Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Apex Dental Materials, Inc. with 15 510(k) clearances. The most recent is a 510(k) clearance dated Nov 8, 2019: BA Pit & Fissure Sealant.
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.
| Nov 8, 2019 | BA Pit & Fissure SealantK190998 · EBC | 510(k) clearances |
| Mar 17, 2017 | RnD TE and RnD SEK161077 · KLE | 510(k) clearances |
| Sep 10, 2013 | APEX UNIVERSAL ADHESIVEK131043 · KLE | 510(k) clearances |
| Aug 27, 2013 | ZRPK131049 · KLE | 510(k) clearances |
| May 31, 2012 | CLEAN AND BOOSTK120620 · KLE | 510(k) clearances |
| Jun 23, 2011 | METAL OPAQUERK110859 · EBF | 510(k) clearances |
| Oct 1, 2009 | SEAMFREEK092539 · EBF | 510(k) clearances |
| Sep 21, 2009 | INJECTAFILK091647 · EBF | 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
