Company · US
Premier Dental Products Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2026. Name variants (Inc, Corp, punctuation) are merged.
47510(k) clearances (1 in 12 months)
17recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | 14 |
| EMA | Cement, Dental | 5 |
| EBF | Material, Tooth Shade, Resin | 4 |
| KLE | Agent, Tooth Bonding, Resin | 4 |
| GEH | Unit, Cryosurgical, Accessories | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 2 |
| MVL | Cord, Retraction | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 |
| EHY | Tray, Impression, Preformed | 1 |
| EJL | Bur, Dental | 1 |
| EKH | Carver, Dental Amalgam, Operative | 1 |
| EKI | Carrier, Amalgam, Operative | 1 |
| EKJ | Burnisher, Operative | 1 |
| EKN | Point, Paper, Endodontic | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 |
| ELC | Scaler, Ultrasonic | 1 |
| ELW | Material, Impression | 1 |
| EMH | Forceps, Rongeur, Surgical | 1 |
| EMN | Scaler, Periodontic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 3, 2026 | K260682 | Bond-PR Universal Adhesive Premier Dental Products Company | KLE |
| Nov 7, 2025 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite Premier Dental Products Company | EBF |
| Dec 6, 2022 | K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite Premier Dental Products Company | EBF |
| Feb 27, 2019 | K180682 | AeroPro Cordless Prophy System Premier Dental Company Products | EKX |
| Oct 18, 2016 | K161580 | Premier Sealant Premier Dental Company Products | EBC |
| Jul 22, 2015 | K150601 | Zeramic Adhesive Resin Cement Premier Dental Company Products | EMA |
| Nov 17, 2014 | K141839 | PREMIER ETCH Premier Dental Products Co. | KLE |
| Nov 26, 2013 | K132526 | KNIT-PAK+ Premier Dental Products Co. | MVL |
| Aug 26, 2013 | K131212 | PREMIER CERAMIC PRIMER Premier Dental Products Co. | KLE |
| Apr 28, 2009 | K083695 | TRAXODENT Premier Dental Products Co. | MVL |
| Nov 21, 2006 | K062683 | ENAMEL PRO VARNISH Premier Dental Products Co. | LBH |
| Nov 21, 2006 | K062166 | ENAMEL PRO Premier Dental Products Co. | EJR |
| Oct 4, 2006 | K061998 | PREMIER SELF-ETCHING BOND ENHANCER Premier Dental Products Co. | KLE |
| Oct 4, 2006 | K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT Premier Dental Products Co. | EBC |
| Sep 6, 2005 | K051866 | PREMIER TEMPORARY CEMENT Premier Dental Products Co. | EMA |
| Sep 21, 2004 | K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT Premier Dental Products Co. | EMA |
| Jan 26, 2004 | K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 Premier Dental Products Co. | EMA |
| Sep 27, 2001 | K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 Premier Dental Products Co. | EBF |
| Apr 17, 2001 | K010195 | PREMIER ULTRASONIC SCALER AND INSERTS Premier Dental Products Co. | ELC |
| Jun 17, 1997 | K970992 | PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS Premier Dental Products Co. | GEH |
| Apr 5, 1995 | K941856 | PREMIER PROMAX BITE GUARD Premier Dental Products Co. | JXL |
| Jan 18, 1995 | K945395 | PREMIER MIRROR WARMER Premier Dental Products Co. | ETF |
| Oct 13, 1992 | K923332 | ELECTROSURGICAL ELECTRODES Premier Dental Products Co. | GEI |
| Jun 24, 1991 | K912149 | HARDCOATED PLASTIC FILLING INSTRUMENT Premier Dental Products Co. | EKJ |
| Jun 9, 1989 | K891536 | ENAMEL MICROABRASION COMPOUND Premier Dental Products Co. | EJR |
| Oct 12, 1984 | K842295 | INTRAUTERINE DEVICE REMOVER Premier Dental Products Co. | HHF |
| Jun 15, 1984 | K841011 | ELEVATOR - VARIOUS Premier Dental Products Co. | EMS |
| Jun 8, 1984 | K841008 | BIOPSY PUNCH, VARIOUS Premier Dental Products Co. | GEE |
| May 30, 1984 | K841006 | EAR KNIFE-VARIOUS Premier Dental Products Co. | JYO |
| May 30, 1984 | K841005 | TONSIL KNIFE-VARIOUS Premier Dental Products Co. | KBQ |
| May 29, 1984 | K841001 | EAR CURETTE, VARIOUS Premier Dental Products Co. | JYG |
| May 11, 1984 | K841004 | SURGICAL CURETTE, VARIOUS Premier Dental Products Co. | HCY |
| May 9, 1984 | K841007 | OPHTHALMIC CURETTE-VARIOUS Premier Dental Products Co. | HNZ |
| May 9, 1984 | K841002 | LACHRYMAL PROBES-VARIOUS Premier Dental Products Co. | HNW |
| May 1, 1984 | K841010 | SURGICAL HOOKS, VARIOUS Premier Dental Products Co. | GDG |
| May 1, 1984 | K841009 | SURGICAL RETRACTORS-VARIOUS Premier Dental Products Co. | GAD |
| Mar 20, 1984 | K841003 | PROBES, VARIOUS Premier Dental Products Co. | KOA |
| Apr 29, 1980 | K800900 | PREMIER TRIPLE TRAY Premier Dental Products Co. | EHY |
| Apr 29, 1980 | K800827 | PREMIER ABSORBENT POINTS Premier Dental Products Co. | EKN |
| Mar 2, 1979 | K790325 | REPRODENT Premier Dental Products Co. | EBI |
| Feb 21, 1979 | K782139 | ZYLOX Premier Dental Products Co. | ELW |
| Jun 30, 1978 | K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX Premier Dental Products Co. | EMN |
| Jun 30, 1978 | K781034 | PREMIER INLAY PLACER Premier Dental Products Co. | EKI |
| Jun 22, 1978 | K780796 | ZYTRON Premier Dental Products Co. | EBF |
| Apr 19, 1978 | K780528 | PREMIER CARVERS, STYLE #21C & 21D Premier Dental Products Co. | EKH |
| Aug 16, 1977 | K771522 | FORCEPS, STYLE #849 Premier Dental Products Co. | EMH |
| Aug 16, 1977 | K771451 | SCUTABOND Premier Dental Products Co. | EMA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2025 | Premier Dental Products Co Premier Solo Diamond - Large Invented Cone; SKU: 807016C. Open, Classified |
EJL | None listed |
| Nov 20, 2004 | Premier Dental Products Co Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument Terminated |
GEH | K970992 |
| Nov 20, 2004 | Premier Dental Products Co Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument Terminated |
GEH | K970992 |
| Sep 15, 2004 | Premier Dental Products Co Laryngectomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050200 size 8 and item number 1050202 size 10. Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co Laryngectomy Tubes, Air Lon Nylon, item number1050170 size 8 and item number 1050172 size 10. Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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 nu Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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 n Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co Laryngectomy Tubes, Martin Stainless Steel, item number 1036128 size 8 and item number 1036130 size10. Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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, ite Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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 s Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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 siz Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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 8100 Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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, Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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 si Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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 Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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, Terminated |
JOH | None listed |
| Sep 15, 2004 | Premier Dental Products Co 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 Terminated |
JOH | None listed |