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 13, 2026, FDA's public records list Opusdent, Ltd. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Aug 7, 2002: OPUSDUO EC DENTAL LASER SYSTEM.
| Date | Record | Source |
|---|---|---|
| Aug 7, 2002 | OPUSDUO EC DENTAL LASER SYSTEMK021508 · GEX | 510(k) clearances |
| Jan 8, 2002 | OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2NDK014100 · GEX | 510(k) clearances |
| Aug 30, 2001 | OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2NDK011769 · GEX | 510(k) clearances |
| Dec 12, 2000 | OPUS 20, MODEL 1STK002899 · GEX | 510(k) clearances |
| Jun 23, 2000 | OPUS 10 DENTAL DIODE LASERK000990 · GEX | 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
