Sybron Dental Specialties, Inc.
Orange, CA, US
Sybron Dental Specialties, Inc. appears in FDA device records in Orange, CA. FDA records list 176 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 93 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
4 namesFDA records resolved to Sybron Dental Specialties, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Albert Browne , Ltd.registration, 510(k)
- Kerr Corporationrecall
- Kerr/Pentron, DBA Kerr Corporation and Pentron Clinicalenforcement report, recall
- Sybronendorecall
510(k) clearance history
Showing 50 of 176FDA records hold 176 510(k) clearances for Sybron Dental Specialties, Inc. between 1994 and 2019. The busiest year on record is 1999, with 17. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 12 |
| 1995 | 7 |
| 1996 | 9 |
| 1997 | 10 |
| 1998 | 9 |
| 1999 | 17 |
| 2000 | 10 |
| 2001 | 17 |
| 2002 | 10 |
| 2003 | 8 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 9 |
| 2007 | 8 |
| 2008 | 5 |
| 2009 | 4 |
| 2010 | 9 |
| 2011 | 4 |
| 2013 | 3 |
| 2015 | 4 |
| 2016 | 7 |
| 2017 | 5 |
| 2018 | 2 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K191548 | Nexus Universal Self-Cure | EMA | Substantially Equivalent | |
| K182162 | OptiBond eXTRa Universal | KLE | Substantially Equivalent | |
| K182826 | Ormco Spark Aligner System | NXC | Substantially Equivalent | |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | MVL | Substantially Equivalent | |
| K163064 | Demi Ultra | EBZ | Substantially Equivalent | |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | KCT | Substantially Equivalent | |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord | MVL | Substantially Equivalent | |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord | MVL | Substantially Equivalent | |
| K162436 | EndoVac Pure | NYL | Substantially Equivalent | |
| K162257 | P1145 Dental Restorative | EBF | Substantially Equivalent | |
| K160097 | Image Fast Set, Image Regular Set | ELW | Substantially Equivalent | |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress | KIF | Substantially Equivalent | |
| K160441 | Identic and KromaFaze Alginate Dental Impression Materials | ELW | Substantially Equivalent | |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWT | KIF | Substantially Equivalent | |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | KIF | Substantially Equivalent | |
| K151526 | Zone, ZoneFree, Zone A1 | EMA | Substantially Equivalent | |
| K151332 | Nexus Universal, Nexus Universal Chroma | EMA | Substantially Equivalent | |
| K150559 | Life Fast Set, Life Regular Set | EJK | Substantially Equivalent | |
| K143209 | SonicFill 2 | EBF | Substantially Equivalent | |
| K130869 | TAKE 1 ADVANCE | ELW | Substantially Equivalent | |
| K123468 | DEMI ULTRA | EBZ | Substantially Equivalent | |
| K123595 | NEXUS RMGI | EMA | Substantially Equivalent | |
| K110747 | TEMPFLEX | EBG | Substantially Equivalent | |
| K110092 | TAKE 1 ADVANCED RIGID TRAY | ELW | Substantially Equivalent | |
| K102621 | SOLSTICE | EBZ | Substantially Equivalent | |
| K103351 | DMC COMPOSITE 2 | EBF | Substantially Equivalent | |
| K101756 | TSC | MVL | Substantially Equivalent | |
| K102163 | REALSEAL XT SEALER | KIF | Substantially Equivalent | |
| K102133 | GIRAFFE2 | MVL | Substantially Equivalent | |
| K101423 | OPTIBOND XTR | KLE | Substantially Equivalent | |
| K100347 | OPTIBOND SE | KLE | Substantially Equivalent | |
| K093341 | CENTURY MODEL 105C | EFB | Substantially Equivalent | |
| K100083 | ESTHETICA | EBF | Substantially Equivalent | |
| K092176 | TAKE 1 ADVANCED RIGID TRAY | ELW | Substantially Equivalent | |
| K093484 | PREMISE FLOWABLE MODIFIED | EBF | Substantially Equivalent | |
| K091091 | SONICFILL 2010 | EBF | Substantially Equivalent | |
| K091613 | TAKE 1 | ELW | Substantially Equivalent | |
| K091023 | METAMORPHOSIS | EBF | Substantially Equivalent | |
| K090292 | PREMISE MODIFIED | EBF | Substantially Equivalent | |
| K082671 | HERCULITE ULTRA | EBF | Substantially Equivalent | |
| K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | ELC | Substantially Equivalent | |
| K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | EFB | Substantially Equivalent | |
| K081695 | DMC COMPOSITE | EBF | Substantially Equivalent | |
| K073209 | MAXCEM 2 | MZW | Substantially Equivalent | |
| K072622 | STANDOUT 2 | ELW | Substantially Equivalent | |
| K071615 | FIXAFLOSS | EEF | Substantially Equivalent | |
| K071429 | TI2200 TRANSILLUMINATION CABLE | NTK | Substantially Equivalent | |
| K071251 | DEMI | EBZ | Substantially Equivalent | |
| K071288 | MODIFICATION TO KAVO QUATTROCARE | EBF | Substantially Equivalent | |
| K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR | LRK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8021896 | 3001168737 | ALBERT BROWNE LTD. | Rayns Way, LEICESTER LE7 1PF GB | 2026 | |
| 2024312 | 2024312 | Kerr Corporation | 1717 W Collins Ave, ORANGE, CA 92867 US | 2026 | and 37 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EJJAlloy, Amalgam
- EFDAmalgamator, Dental, Ac-Powered
- IWOApron, Protective
- DYWBracket, Plastic, Orthodontic
- DZSCapsule, Dental, Amalgam
- EMACement, Dental
- EEFClamp, Rubber Dam
- FLGCleaner, Ultrasonic, Medical Instrument
- KJJCleanser, Root Canal
- EBWController, Foot, Handpiece And Cord
- EBGCrown And Bridge, Temporary, Resin
- LRKDevice, Anti-Snoring
- MECDisinfector, Medical Devices
- DZADrill, Dental, Intraoral
- EKBExplorer, Operative
- EKSFile, Pulp Canal, Endodontic
- EILGauge, Depth, Instrument, Dental
- EFBHandpiece, Air-Powered, Dental
- EFAHandpiece, Belt And/Or Gear Driven, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- HBMHeadrest, Neurosurgical
- FRCIndicator, Biological Sterilization Process
- JOJIndicator, Physical/Chemical Sterilization Process
- LRTIndicator, Sterilization
- EIYInstrument, Filling, Plastic, Dental
- DZNInstruments, Dental Hand
- EJKLiner, Cavity, Calcium Hydroxide
- LQYLocator, Root Apex
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- ELYMercury
- FWZOperating Room Accessories Table Tray
- EFHPaper, Articulation
- JEXPlier, Orthodontic
- EJYPliers, Operative
- EKRPlugger, Root Canal, Endodontic
- EKNPoint, Paper, Endodontic
- EKQPreparer, Root Canal Endodontic
- BRWProtector, Dental
- EKPReamer, Pulp Canal, Endodontic
- EBIResin, Denture, Relining, Repairing, Rebasing
- KIFResin, Root Canal Filling
- EIGRetractor, All Types
- ELBScaler, Rotary
- ELCScaler, Ultrasonic
- EBCSealant, Pit And Fissure, And Conditioner
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- BWNTable And Attachments, Operating-Room
- FQOTable, Operating-Room, Ac-Powered
- GDCTable, Operating-Room, Electrical
- EATTester, Pulp
- KMTTray, Fluoride, Disposable
- FSMTray, Surgical, Instrument
- EIAUnit, Operative Dental
- FRGWrap, Sterilization
- EMBZinc Oxide Eugenol
Recall records
Showing 25 of 93| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1824-2020 | Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments. | An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures. | Class II | Terminated | |
| Z-1721-2019 | Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution | Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. | Class II | Terminated | |
| Z-1291-2015 | Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500 | Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination. | Class II | Terminated | |
| Z-2259-2013 | NX3 Try-In Gel. The product is used as a tooth shade resin material. | Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled. | Class II | Terminated | |
| Z-2195-2013 | AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic. | The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly. | Class II | Terminated | |
| Z-1076-2013 | Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations. | Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite is causing the material to prematurely polymerize in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to placing restorations on the tooth or core build-up. As a result, the restoration may not be seated properly. | Class II | Terminated | |
| Z-0401-2013 | BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement. | The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process. | Class II | Terminated | |
| Z-0186-2012 | Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations. | Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product. | Terminated | ||
| Z-0157-2012 | 37% Etching Gel-5ml syringe, part #N01IB The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label. | Terminated | ||
| Z-0156-2012 | 37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label. | Terminated | ||
| Z-0155-2012 | 37% Etching Gel-1ml syringe 50 pk, part # T06B The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label. | Terminated | ||
| Z-0154-2012 | 37% Etching Gel-1ml syringe 20 pk, part # T06A The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label. | Terminated | ||
| Z-0153-2012 | 37% Etching Gel-1ml syringe, part # T06 The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent. | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label. | Terminated | ||
| Z-0454-2012 | Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives. | The firm initiated a recall because the product sets faster than specified in the "Directions for Use" and in release specifications. | Terminated | ||
| Z-1205-2012 | Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth. | The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste, and it may set faster than specified. | Terminated | ||
| Z-0990-2012 | Flow Tec Nano-Hybrid Flowable Affected Product Syringe Part No. Value Pack Part. No. Shade BEN3784-514 BEN3786-754 A1 BEN3784-532 BEN3786-763 A2 BEN3784-541 BEN3784-738 A3 BEN3784-550 BEN3784-747 A3.5 BEN3784-569 BEN3784-756 A4 BEN3784-578 BEN3784-765 B1 BEN3784-596 BEN3784-774 B2 BEN3784-603 BEN3784-783 C1 BEN3784-612 BEN3784-792 C2 BEN3784-621 BEN3784-809 C3 BEN3784-649 BEN3784-818 D2 BEN3784-722 BEN3784-818 Universal Opaque BEN3784-685 BEN3784-827 A0 BEN3784-701 BEN3784-836 Incisal. The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. | The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. | Terminated | ||
| Z-0989-2012 | Artiste Nano-Hybrid Affected Product. Syringe Part No. Value Pack Part. No Shade N28A N28VA A1 N28B N28VB A2 N28C N28VC A3 N28D N28VD A3.5 N28E N28VE A4 N28F N28VF B1 N28G N28VG B2 N28J N28VJ C1 N28K N28VK C2 N28L N28VL C3 N28N N28VP D2 N28R N28VR Universal Opaque N28XA N28VXA A0 N28XC N28VXC Incisal. The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. | The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. | Terminated | ||
| Z-0455-2012 | Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. | The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product. | Terminated | ||
| Z-0915-2012 | Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants | The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds. | Terminated | ||
| Z-1100-2012 | Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts. | The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in inadequate bond strength. | Terminated | ||
| Z-1146-2012 | Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material. | Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker. | Terminated | ||
| Z-1007-2012 | Flow Tec Part Number 3786-754, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | Terminated | ||
| Z-1006-2012 | Flow Tec Part Number 3784-514, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | Terminated | ||
| Z-1000-2012 | Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | Terminated | ||
| Z-1005-2012 | Artiste Flowable Part Number N28A, Syringe Lot Number 165741 The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc. | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain