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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Den-Mat Holdings with 9 510(k) clearances and 2 drug recalls. The most recent is a 510(k) clearance dated Sep 24, 2026: MPa Max adhesive.
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.
| Sep 24, 2026 | MPa Max adhesiveK262252 · KLE | 510(k) clearances |
| Oct 15, 2024 | DenMat Bulk Fill CompositeK242097 · EBF | 510(k) clearances |
| Jan 16, 2024 | Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-1Class II · CGMP Deviations: products may not conform to the labeled specifications. | Drug recalls |
| Jan 16, 2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Class II · CGMP Deviations: products may not conform to the labeled specifications. | Drug recalls |
| Mar 24, 2017 | nuance UNIVERSALK162967 · EBF | 510(k) clearances |
| May 1, 2015 | Nuance FLOWK143679 · EBF | 510(k) clearances |
| Aug 20, 2014 | TENURE4GK140537 · KLE | 510(k) clearances |
| Feb 10, 2011 | SPPHINE PLUS STM 3W DIODE LASERK110079 · GEX | 510(k) clearances |
| Dec 29, 2010 | SAPPHIRE ST PORTABLE DIODE LASERK103667 · GEX | 510(k) clearances |
| Nov 21, 2008 | SAPPHIRE PLASMA ARC DENTAL CURING LIGHTK081287 · EBZ | 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
