Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Premier Dental Products Co. · Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
119 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141839 | PREMIER ETCH | Premier Dental Products Co. | 2014-11-17 | 132 | 0 |
| K132526 | KNIT-PAK+ | Premier Dental Products Co. | 2013-11-26 | 106 | 0 |
| K131212 | PREMIER CERAMIC PRIMER | Premier Dental Products Co. | 2013-08-26 | 119 | 0 |
| K083695 | TRAXODENT | Premier Dental Products Co. | 2009-04-28 | 134 | 0 |
| K062683 | ENAMEL PRO VARNISH | Premier Dental Products Co. | 2006-11-21 | 74 | 0 |
| K062166 | ENAMEL PRO | Premier Dental Products Co. | 2006-11-21 | 116 | 0 |
| K061998 | PREMIER SELF-ETCHING BOND ENHANCER | Premier Dental Products Co. | 2006-10-04 | 82 | 0 |
| K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | Premier Dental Products Co. | 2006-10-04 | 82 | 0 |
| K051866 | PREMIER TEMPORARY CEMENT | Premier Dental Products Co. | 2005-09-06 | 57 | 0 |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | Premier Dental Products Co. | 2004-09-21 | 36 | 0 |
| K033309 | PREMIER IMPLANT CEMENT, MODEL 3001450 | Premier Dental Products Co. | 2004-01-26 | 104 | 0 |
| K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 | Premier Dental Products Co. | 2001-09-27 | 78 | 0 |
| K010195 | PREMIER ULTRASONIC SCALER AND INSERTS | Premier Dental Products Co. | 2001-04-17 | 85 | 0 |
| K970992 | PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS | Premier Dental Products Co. | 1997-06-17 | 90 | 2 |
| K941856 | PREMIER PROMAX BITE GUARD | Premier Dental Products Co. | 1995-04-05 | 355 | 0 |
| K945395 | PREMIER MIRROR WARMER | Premier Dental Products Co. | 1995-01-18 | 76 | 0 |
| K923332 | ELECTROSURGICAL ELECTRODES | Premier Dental Products Co. | 1992-10-13 | 98 | 0 |
| K912149 | HARDCOATED PLASTIC FILLING INSTRUMENT | Premier Dental Products Co. | 1991-06-24 | 40 | 0 |
| K891536 | ENAMEL MICROABRASION COMPOUND | Premier Dental Products Co. | 1989-06-09 | 84 | 0 |
| K842295 | INTRAUTERINE DEVICE REMOVER | Premier Dental Products Co. | 1984-10-12 | 123 | 0 |
| K841011 | ELEVATOR - VARIOUS | Premier Dental Products Co. | 1984-06-15 | 98 | 0 |
| K841008 | BIOPSY PUNCH, VARIOUS | Premier Dental Products Co. | 1984-06-08 | 91 | 0 |
| K841005 | TONSIL KNIFE-VARIOUS | Premier Dental Products Co. | 1984-05-30 | 82 | 0 |
| K841006 | EAR KNIFE-VARIOUS | Premier Dental Products Co. | 1984-05-30 | 82 | 0 |
| K841001 | EAR CURETTE, VARIOUS | Premier Dental Products Co. | 1984-05-29 | 81 | 0 |
| K841004 | SURGICAL CURETTE, VARIOUS | Premier Dental Products Co. | 1984-05-11 | 63 | 0 |
| K841002 | LACHRYMAL PROBES-VARIOUS | Premier Dental Products Co. | 1984-05-09 | 61 | 0 |
| K841007 | OPHTHALMIC CURETTE-VARIOUS | Premier Dental Products Co. | 1984-05-09 | 61 | 0 |
| K841010 | SURGICAL HOOKS, VARIOUS | Premier Dental Products Co. | 1984-05-01 | 53 | 0 |
| K841009 | SURGICAL RETRACTORS-VARIOUS | Premier Dental Products Co. | 1984-05-01 | 53 | 0 |
| K841003 | PROBES, VARIOUS | Premier Dental Products Co. | 1984-03-20 | 11 | 0 |
| K800827 | PREMIER ABSORBENT POINTS | Premier Dental Products Co. | 1980-04-29 | 15 | 0 |
| K800900 | PREMIER TRIPLE TRAY | Premier Dental Products Co. | 1980-04-29 | 11 | 0 |
| K790325 | REPRODENT | Premier Dental Products Co. | 1979-03-02 | 15 | 0 |
| K782139 | ZYLOX | Premier Dental Products Co. | 1979-02-21 | 56 | 0 |
| K781034 | PREMIER INLAY PLACER | Premier Dental Products Co. | 1978-06-30 | 11 | 0 |
| K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | Premier Dental Products Co. | 1978-06-30 | 11 | 0 |
| K780796 | ZYTRON | Premier Dental Products Co. | 1978-06-22 | 38 | 0 |
| K780528 | PREMIER CARVERS, STYLE #21C & 21D | Premier Dental Products Co. | 1978-04-19 | 16 | 0 |
| K771522 | FORCEPS, STYLE #849 | Premier Dental Products Co. | 1977-08-16 | 8 | 0 |
| K771451 | SCUTABOND | Premier Dental Products Co. | 1977-08-16 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda