510(k) K922615 ยท KLE Agent, Tooth Bonding, Resin
COLTENE A.R.T. BOND
| Applicant | Coltene/Whaledent, Inc., New York NY, US |
| Decision | Substantially Equivalent, Aug 3, 1992 |
| Received | Jun 2, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922615
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.