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 Pac-Dent International with 11 510(k) clearances. The most recent is a 510(k) clearance dated Oct 20, 2017: GingiDent Gingival Retraction Paste.
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.
| Oct 20, 2017 | GingiDent Gingival Retraction PasteK162662 · MVL | 510(k) clearances |
| Jul 25, 2016 | PacEndo ChlorhexidineK160577 · KJJ | 510(k) clearances |
| Mar 3, 2016 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmK151123 · PEM | 510(k) clearances |
| Feb 1, 2016 | PacEndo EDTAK153528 · KJJ | 510(k) clearances |
| Nov 10, 2015 | PacEndo Sodium HyprochloriteK151852 · KJJ | 510(k) clearances |
| Jul 28, 2015 | ElementsK151150 · ELW | 510(k) clearances |
| Mar 9, 2015 | PACSEAL PIT & FISSURE SEALANTK141717 · EBC | 510(k) clearances |
| Sep 30, 2014 | PROFLUORO FLUORIDE VARNISHK141422 · LBH | 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
