Premier Dental Products Co
Plymouth Meeting, PA, US
PREMIER DENTAL PRODUCTS CO. appears in FDA device records in Plymouth Meeting, PA. FDA records list 44 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 17 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 44 510(k) clearances for Premier Dental Products Co between 1977 and 2026. The busiest year on record is 1984, with 12. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 4 |
| 1979 | 2 |
| 1980 | 2 |
| 1984 | 12 |
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| 2001 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 4 |
| 2009 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260682 | Bond-PR™ Universal Adhesive | KLE | Substantially Equivalent | |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | EBF | Substantially Equivalent | |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite | EBF | Substantially Equivalent | |
| K141839 | PREMIER ETCH | KLE | Substantially Equivalent | |
| K132526 | KNIT-PAK+ | MVL | Substantially Equivalent | |
| K131212 | PREMIER CERAMIC PRIMER | KLE | Substantially Equivalent | |
| K083695 | TRAXODENT | MVL | Substantially Equivalent | |
| K062683 | ENAMEL PRO VARNISH | LBH | Substantially Equivalent | |
| K062166 | ENAMEL PRO | EJR | Substantially Equivalent | |
| K061998 | PREMIER SELF-ETCHING BOND ENHANCER | KLE | Substantially Equivalent | |
| K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | EBC | Substantially Equivalent | |
| K051866 | PREMIER TEMPORARY CEMENT | EMA | Substantially Equivalent | |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | EMA | Substantially Equivalent | |
| K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | EMA | Substantially Equivalent | |
| K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 | EBF | Substantially Equivalent | |
| K010195 | PREMIER ULTRASONIC SCALER AND INSERTS | ELC | Substantially Equivalent | |
| K970992 | PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS | GEH | Substantially Equivalent | |
| K941856 | PREMIER PROMAX BITE GUARD | JXL | Substantially Equivalent | |
| K945395 | PREMIER MIRROR WARMER | ETF | Substantially Equivalent | |
| K923332 | ELECTROSURGICAL ELECTRODES | GEI | Substantially Equivalent | |
| K912149 | HARDCOATED PLASTIC FILLING INSTRUMENT | EKJ | Substantially Equivalent | |
| K891536 | ENAMEL MICROABRASION COMPOUND | EJR | Substantially Equivalent | |
| K842295 | INTRAUTERINE DEVICE REMOVER | HHF | Substantially Equivalent | |
| K841011 | ELEVATOR - VARIOUS | EMS | Substantially Equivalent | |
| K841008 | BIOPSY PUNCH, VARIOUS | GEE | Substantially Equivalent | |
| K841006 | EAR KNIFE-VARIOUS | JYO | Substantially Equivalent | |
| K841005 | TONSIL KNIFE-VARIOUS | KBQ | Substantially Equivalent | |
| K841001 | EAR CURETTE, VARIOUS | JYG | Substantially Equivalent | |
| K841004 | SURGICAL CURETTE, VARIOUS | HCY | Substantially Equivalent | |
| K841007 | OPHTHALMIC CURETTE-VARIOUS | HNZ | Substantially Equivalent | |
| K841002 | LACHRYMAL PROBES-VARIOUS | HNW | Substantially Equivalent | |
| K841010 | SURGICAL HOOKS, VARIOUS | GDG | Substantially Equivalent | |
| K841009 | SURGICAL RETRACTORS-VARIOUS | GAD | Substantially Equivalent | |
| K841003 | PROBES, VARIOUS | KOA | Substantially Equivalent | |
| K800900 | PREMIER TRIPLE TRAY | EHY | Substantially Equivalent | |
| K800827 | PREMIER ABSORBENT POINTS | EKN | Substantially Equivalent | |
| K790325 | REPRODENT | EBI | Substantially Equivalent | |
| K782139 | ZYLOX | ELW | Substantially Equivalent | |
| K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | EMN | Substantially Equivalent | |
| K781034 | PREMIER INLAY PLACER | EKI | Substantially Equivalent | |
| K780796 | ZYTRON | EBF | Substantially Equivalent | |
| K780528 | PREMIER CARVERS, STYLE #21C & 21D | EKH | Substantially Equivalent | |
| K771522 | FORCEPS, STYLE #849 | EMH | Substantially Equivalent | |
| K771451 | SCUTABOND | EMA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2511556 | 2511556 | PREMIER DENTAL PRODUCTS CO. | 1710 Romano Dr, PLYMOUTH MEETING, PA 19462 US | 2026 | and 91 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- EJPArticulators
- EKJBurnisher, Operative
- EKICarrier, Amalgam, Operative
- EKHCarver, Dental Amalgam, Operative
- EIKCarver, Wax, Dental
- EMACement, Dental
- EMMChisel, Osteotome, Surgical
- EKGCondenser, Amalgam And Foil, Operative
- EFNCotton, Roll
- EHKCup, Prophylaxis
- EMSCurette, Periodontic
- EMKCurette, Surgical, Dental
- EHJDisk, Abrasive
- DZADrill, Dental, Intraoral
- EMJElevator, Surgical, Dental
- EKCExcavator, Dental, Operative
- EKBExplorer, Operative
- EMIFile, Bone, Surgical
- EMRFile, Periodontic
- EFKForceps, Articulation Paper
- EMHForceps, Rongeur, Surgical
- EJGForceps, Rubber Dam Clamp
- EMGForceps, Tooth Extractor, Surgical
- EILGauge, Depth, Instrument, Dental
- EJBHandle, Instrument, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- EMDHemostat, Surgical
- EKDInstrument, Cutting, Operative
- DZPInstrument, Diamond, Dental
- EIYInstrument, Filling, Plastic, Dental
- ELAInstrument, Hand, Calculus Removal
- DZNInstruments, Dental Hand
- EJZKnife, Margin Finishing, Operative
- EMOKnife, Periodontic
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- EJYPliers, Operative
- EKRPlugger, Root Canal, Endodontic
- EKNPoint, Paper, Endodontic
- ELRPost, Root Canal
- EKQPreparer, Root Canal Endodontic
- EIXProbe, Periodontic
- EISRemover, Crown
- EBIResin, Denture, Relining, Repairing, Rebasing
- EIGRetractor, All Types
- EMNScaler, Periodontic
- ELCScaler, Ultrasonic
- EIRScissors, Collar And Crown
- EGNScissors, Surgical Tissue, Dental
- EBCSealant, Pit And Fissure, And Conditioner
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- EHMStrip, Polishing Agent
- EIDSyringe, Restorative And Impression Material
- ELLTeeth, Porcelain
- EHYTray, Impression, Preformed
- BTOTube, Tracheostomy (W/Wo Connector)
- EFCWarmer, Anesthetic Tube
- EJQWheel, Polishing Agent
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1408-2025 | Premier Solo Diamond - Large Invented Cone; SKU: 807016C. | The hardness not meeting the material specification and may cause the diamond bur to bend. | Class II | Open, Classified | |
| Z-1471-04 | Laryngectomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050200 size 8 and item number 1050202 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1470-04 | Laryngectomy Tubes, Air Lon Nylon, item number1050170 size 8 and item number 1050172 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1469-04 | Laryngectomy Tubes, Jackson Improved Stainless Steel, item number1037414 size 4, item number 1037415 size 5, item number 1037416 size 6, item number 1037417 size 7, item number 1037418 size 8, item number 1037419 size 9, and item number 1037420 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1468-04 | Laryngectomy Tubes, Jackson Original Stainless Steel, item number 1037214 size 4, item number 1037215 size 5, item number 1037216 size 6, item number 1037217 size 7, item number 1037218 size 8, item number 1037219 size 9, and item number 1037220 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1467-04 | Laryngectomy Tubes, Martin Stainless Steel, item number 1036128 size 8 and item number 1036130 size10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1466-04 | Tracheostomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050180 size 3, item number 1050182 size 4, item number 1050184 size 5, item number 1050186 size 6, item number 1050188 size 7, and item number 1050190 size 8. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1465-04 | Tracheostomy Tubes, Air Lon Nylon, item number 1050150 size 3, item number 1050152 size 4, item number 1050154 size 5, item number 1050156 size 6, item number 1050158 size 7, and item number 1050160 size 8. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1464-04 | Tracheostomy Tubes, Jackson Improved Extra Long Stainless Steel, item number 1034964 size 4, item number 1034965 size 5, item number 1034966 size 6, item number 1034967 size 7, item number 1034968 size 8, item number 1034969 size 9, and item number 1034970 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1463-04 | Tracheostomy Tubes, Jackson Improved Short Stainless Steel with Adapter, item number 8100402 size 3,item number 8100040 size 4, item number 8100041 size 5, item number 8100229 size 6, item number 8100322 size 7, item number 8100374 size 8, item number 8100282 size 9, and item number 8100709 size10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1462-04 | Tracheostomy Tubes, Jackson Improved Short Stainless Steel, item number 1034930 size 00, item number 1034940 size 0, item number 1034941 size 1, item number 1034942 size 2, item number 1034943 size 3, item number 1034944 size 4, item number 1034945 size 5, item number 1034946 size 6, item number 1034947 size 7, item number 1034948 size 8, item number 1034949 size 9, and item number 1034950 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1461-04 | Tracheostomy Tubes, Jackson Improved Stainless Steel with Adapter, item number 8100465 size 1, item number 8100373 size 3, item number 1034924 size 4, item number 1034925 size5, item number 1034926 size 6, item number 1034927 size 7, item number 1034928 size 8, item number 8100468 size 9, and item number 8100234 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1460-04 | Tracheostomy Tubes, Jackson Improved Stainless Steel, item number 1034900 size 00, item number 1034910 size 0, item number 1034911 size 1, item number 1034912 size 2, item number 1034913 size 3, item number 1034914 size 4, item number 1034915 size 5, item number 1034916 size 6, item number 1034917 size 7, item number 1034918 size 8, item number 1034919 size 9, and item number 1034920 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1459-04 | Tracheostomy Tubes, Jackson Original Short Stainless Steel, item number 1034600 size 00, item number 1034610 size 0, item number 1034611 size 1, item number 1034612 size 2, item number 1034613 size 3, item number 1034614 size 4,item number 1034615 size 5, item number 1034616 size 6, item number 1034617 size 7, item number 1034618 size 8, item number 1034619 size 9, and item number 1034620 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-1458-04 | Tracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size 0, item number 1034311 size 1, item number 1034312 size 2, item number 1034313 size 3, item number 1034314 size 4, item number 1034315 size 5, item number 1034316 size 6, item number 1034317 size 7, item number 1034318 size 8, item number 1034319 size 9, and item number 1034320 size 10. | foreign objects (polishing stones) in the tubes | Terminated | ||
| Z-0216-05 | Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument | Cryogen can escape from canister through the seal ring | Terminated | ||
| Z-0215-05 | Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument | Cryogen can escape from canister through the seal ring | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain