Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 2 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list Performance Health and its 2 subsidiaries with 67 510(k) clearances. The most recent is a 510(k) clearance dated Jan 26, 1996: DENTAL DAM.
| Jan 26, 1996 | DENTAL DAMK954990 · EIE | 510(k) clearances |
| May 27, 1993 | ENDO-ICE-PULP TESTER-THERMALK930764 · EAT | 510(k) clearances |
| Jul 25, 1991 | GATES GLIDDEN DRILLSK905418 · DZA | 510(k) clearances |
| Apr 17, 1991 | TRAY DOUGHK911225 · KGS | 510(k) clearances |
| Mar 5, 1991 | SOLID CORE GUTTA PERCHA CARRIERK905640 · EKS | 510(k) clearances |
| May 15, 1990 | NOVUS BONDING AGENTK900301 · EBI | 510(k) clearances |
| Apr 16, 1990 | WEDJETSK900844 · EIE | 510(k) clearances |
| Jan 10, 1990 | DENTAL ENDODONTIC CEMENT (MODIFICATION)K894092 · KIF | 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
