Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Premier Dental Products Company with 47 510(k) clearances, 1 drug recall and 1 device recall. The most recent is a drug recall dated Apr 14, 2026: Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Prem….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 14, 2026 | Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth MeClass III · Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 inst | Drug recalls |
| Mar 3, 2026 | Bond-PR™ Universal AdhesiveK260682 · KLE | 510(k) clearances |
| Nov 7, 2025 | MultiMatch Flow Chameleon AntiMicrobial CompositeK253513 · EBF | 510(k) clearances |
| Feb 27, 2025 | Premier Solo Diamond - Large Invented Cone; SKU: 807016C.Class II · The hardness not meeting the material specification and may cause the diamond bur to bend. | Device recalls |
| Dec 6, 2022 | Premier's MultiMatch Universal Chameleon Restorative CompositeK223632 · EBF | 510(k) clearances |
| Feb 27, 2019 | AeroPro Cordless Prophy SystemK180682 · EKX | 510(k) clearances |
| Oct 18, 2016 | Premier SealantK161580 · EBC | 510(k) clearances |
| Jul 22, 2015 | Zeramic Adhesive Resin CementK150601 · EMA | 510(k) clearances |
| Nov 17, 2014 | PREMIER ETCHK141839 · KLE | 510(k) clearances |
| Nov 26, 2013 | KNIT-PAK+K132526 · MVL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
