Premier Dental Products Co.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Premier Dental Products Co.” (first 1977, latest 2014), across 33 product codes in 7 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 112 |
| 2014 | 1 | 132 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMA | Cement, Dental | 4 | 4 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 2 | 2 |
| MVL | Cord, Retraction | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EHY | Tray, Impression, Preformed | 1 | 1 |
| EKH | Carver, Dental Amalgam, Operative | 1 | 1 |
| EKI | Carrier, Amalgam, Operative | 1 | 1 |
Plus 23 more product codes.
Review panels
- Dental (26)
- General and Plastic Surgery (5)
- Ear, Nose and Throat (4)
- Obstetrics and Gynecology (2)
- Ophthalmic (2)
- Gastroenterology and Urology (1)
- Neurology (1)
Most recent Premier Dental Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141839 | PREMIER ETCH | KLE | 2014-11-17 | 132 |
| K132526 | KNIT-PAK+ | MVL | 2013-11-26 | 106 |
| K131212 | PREMIER CERAMIC PRIMER | KLE | 2013-08-26 | 119 |
| K083695 | TRAXODENT | MVL | 2009-04-28 | 134 |
| K062683 | ENAMEL PRO VARNISH | LBH | 2006-11-21 | 74 |
| K062166 | ENAMEL PRO | EJR | 2006-11-21 | 116 |
| K061998 | PREMIER SELF-ETCHING BOND ENHANCER | KLE | 2006-10-04 | 82 |
| K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | EBC | 2006-10-04 | 82 |
| K051866 | PREMIER TEMPORARY CEMENT | EMA | 2005-09-06 | 57 |
| K042215 | RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT | EMA | 2004-09-21 | 36 |
31 earlier clearances. See the full list in Caduvo.
Recalls
17 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2025-02-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Premier Laser Systems, Inc. (14 510(k)s)
- Premier North America, Inc. (6 510(k)s)
- Premier Dental Company Products (3 510(k)s)
- Premier Dental Products Company (3 510(k)s)
- Premier Medical (3 510(k)s)
- Premier Biotech, Inc. (2 510(k)s)
- Premier (1 510(k)s)
- Premier Anesthesia Systems (1 510(k)s)
- Premier Brands of America, Inc. (1 510(k)s)
- Premier Dental (1 510(k)s)
- Premier Designs (1 510(k)s)
- Premier Dynamics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Premier Dental Products Co.?
FDA lists 41 510(k) clearances under the applicant name “Premier Dental Products Co.” (first 1977, latest 2014), across 33 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Premier Dental Products Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Premier Dental Products Co. is 76 days.
Which FDA product codes appear under Premier Dental Products Co.?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 4); KLE (Agent, Tooth Bonding, Resin, 3); EBF (Material, Tooth Shade, Resin, 2).
Next steps
- See all 41 Premier Dental Products Co. clearances with predicates and recalls
- Run predicate analysis for product code EMA, Premier Dental Products Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.