Coltene /Whaledent AG
Cuyahoga Falls, OH, US
COLTENE/WHALEDENT AG appears in FDA device records in Cuyahoga Falls, OH. FDA records list 39 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 15 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 39 510(k) clearances for Coltene /Whaledent AG between 1991 and 2022. The busiest year on record is 2005, with 5. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 3 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2011 | 1 |
| 2013 | 2 |
| 2015 | 2 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220097 | PRESIDENT The Original | ELW | Substantially Equivalent | |
| K191385 | BRILLIANT COMPONEER | EBF | Substantially Equivalent | |
| K190597 | BRILLIANT EverGlow Flow | EBF | Substantially Equivalent | |
| K181500 | BRILLIANT Crios | EBF | Substantially Equivalent | |
| K160800 | DuoCem | EMA | Substantially Equivalent | |
| K152927 | BRILLIANT EVERGLOW | EBF | Substantially Equivalent | |
| K152243 | One Coat 7 Universal | KLE | Substantially Equivalent | |
| K150218 | Fill-Up! | EBF | Substantially Equivalent | |
| K130137 | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER | ELC | Substantially Equivalent | |
| K121621 | SOLOCEM | EMA | Substantially Equivalent | |
| K112168 | COMPONEER | EBF | Substantially Equivalent | |
| K083304 | TEMPOSIL 2 | EMA | Substantially Equivalent | |
| K072604 | DUO TEMP | EMA | Substantially Equivalent | |
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | EKZ | Substantially Equivalent | |
| K052820 | PARAPOST PARACORE AUTOMIX 5ML | EBF | Substantially Equivalent | |
| K053040 | PARACEM UNIVERSAL DC | EMA | Substantially Equivalent | |
| K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM | KMH | Substantially Equivalent | |
| K051243 | JET BLUE BITE | ELW | Substantially Equivalent | |
| K050426 | TEMPOSIL, MODEL 6720 | EMA | Substantially Equivalent | |
| K050013 | RETRACTOFOAM | ELW | Substantially Equivalent | |
| K040551 | COLTOLUX LED CURING LIGHT | EBZ | Substantially Equivalent | |
| K033760 | ONE COAT SE BOND | KLE | Substantially Equivalent | |
| K031752 | COLTOSOL F | EMA | Substantially Equivalent | |
| K013400 | SYNERGY FLOW | EBF | Substantially Equivalent | |
| K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | EBF | Substantially Equivalent | |
| K993545 | TENAX WHITE POST | ELR | Substantially Equivalent | |
| K000311 | PARAPOST FIBER WHITE | ELR | Substantially Equivalent | |
| K993710 | MODIFICATION OF PARAPOST CEMENT | EMA | Substantially Equivalent | |
| K993835 | PARAPOST SYSTEM STERILIZABLE ORGANIZER | FRG | Substantially Equivalent | |
| K993255 | BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE | FRG | Substantially Equivalent | |
| K983727 | BIOSONIC ULTRASONIC SCALER SYSTEM | ELC | Substantially Equivalent | |
| K974906 | ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM | KLE | Substantially Equivalent | |
| K974465 | SYNERGY | EBF | Substantially Equivalent | |
| K950106 | COLTOLUX LIGHT METER | EBZ | Substantially Equivalent | |
| K945698 | COLTOLUX 3, COLTOLUX 4 | EBZ | Substantially Equivalent | |
| K945366 | PARAPOST CEMENT | EMA | Substantially Equivalent | |
| K934192 | PARAPOST XT SYSTEM | ELR | Substantially Equivalent | |
| K922615 | COLTENE A.R.T. BOND | KLE | Substantially Equivalent | |
| K912485 | COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC | ELW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613375 | 3002806620 | COLTENE/WHALEDENT AG | FELDWIESENSTRASSE 20, ALTSTAETTEN Sankt Gallen CH-9450 CH | 2026 | and 3 more, listed in full below |
| 2416455 | 2416455 | COLTENE/WHALEDENT INC. | 235 Ascot Pkwy, CUYAHOGA FALLS, OH 44223 US | 2026 | and 24 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- NDPAccessories, Implant, Dental, Endosseous
- EIFAccessories, Retractor, Dental
- EBZActivator, Ultraviolet, For Polymerization
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EJLBur, Dental
- EMACement, Dental
- EEFClamp, Rubber Dam
- FLGCleaner, Ultrasonic, Medical Instrument
- KJJCleanser, Root Canal
- EBGCrown And Bridge, Temporary, Resin
- EIEDam, Rubber
- LRJDisinfectant, Medical Devices
- EHJDisk, Abrasive
- KYXDispenser, Liquid Medication
- DZADrill, Dental, Intraoral
- EKSFile, Pulp Canal, Endodontic
- EJGForceps, Rubber Dam Clamp
- EJEFrame, Rubber Dam
- EJBHandle, Instrument, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- DZPInstrument, Diamond, Dental
- DZNInstruments, Dental Hand
- LQYLocator, Root Apex
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- DZMNeedle, Dental
- EBLPin, Retentive And Splinting, And Accessory Instruments
- EHLPoint, Abrasive
- ELRPost, Root Canal
- EKQPreparer, Root Canal Endodontic
- KIFResin, Root Canal Filling
- ELCScaler, Ultrasonic
- KMHSterilizer, Dry Heat
- EHMStrip, Polishing Agent
- EICSyringe, Periodontic, Endodontic, Irrigating
- EIDSyringe, Restorative And Impression Material
- EATTester, Pulp
- EHYTray, Impression, Preformed
- EKZUnit, Electrosurgical, And Accessories, Dental
- EGDWax, Dental, Intraoral
- EJQWheel, Polishing Agent
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1208-2023 | SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001 | Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button | Class II | Open, Classified | |
| Z-1494-2021 | Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741 | The incorrect dental pins were packaged and subsequently distributed. | Class II | Open, Classified | |
| Z-0468-2021 | Strauss 25 Carbide Dental Burs (100057XXV) | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | Class II | Open, Classified | |
| Z-0467-2021 | CEI Cutting Edge Instruments (PTC-57C) | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | Class II | Open, Classified | |
| Z-0466-2021 | Clinic Pack 100 Pieces FG 57 100057C (100057C) | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | Class II | Open, Classified | |
| Z-0465-2021 | FG 57 100057X (100057X) | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | Class II | Open, Classified | |
| Z-0464-2021 | Alpen Clinic 100 Carbide Instruments (R100057C) | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. | Class II | Open, Classified | |
| Z-2422-2020 | HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam. | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | Class II | Open, Classified | |
| Z-2421-2020 | HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam. | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | Class II | Open, Classified | |
| Z-2420-2020 | HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam. | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | Class II | Open, Classified | |
| Z-2419-2020 | HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam. | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | Class II | Open, Classified | |
| Z-2436-2019 | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length. | Class II | Terminated | |
| Z-0376-2019 | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. | ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 | Class II | Terminated | |
| Z-1883-2018 | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. | The products are labeled with an incorrect product number. | Class II | Terminated | |
| Z-2151-2014 | Latex Dental Dams labeled as Non-Latex Dental Dams | Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain