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 Ortho Source with 9 510(k) clearances. The most recent is a 510(k) clearance dated Aug 27, 1992: FISSURE SEALER.
| Date | Record | Source |
|---|---|---|
| Aug 27, 1992 | FISSURE SEALERK913853 · EBC | 510(k) clearances |
| Jan 14, 1992 | ORTHO LIGHT CUREK913854 · DYH | 510(k) clearances |
| Nov 19, 1991 | SUMO GLASS IONOMER CEMENTK913519 · EMA | 510(k) clearances |
| Feb 23, 1989 | VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINERK884949 · EJK | 510(k) clearances |
| Jan 3, 1989 | MAXIBONDK884575 · DYH | 510(k) clearances |
| May 2, 1986 | ORTHOJOIN, ORTHODONTIC ADHESIVEK861118 · DYH | 510(k) clearances |
| Apr 17, 1986 | PERMABAND (ORTHODONTIC ADHESIVE)K861258 · DYH | 510(k) clearances |
| Apr 11, 1986 | ORTHOSOURCE ETCH SYSTEMSK861245 · EBC | 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
