510(k) K980543 ยท EHD Unit, X-Ray, Extraoral With Timer
DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
| Applicant | Dentsply Intl., Des Plaines IL, US |
| Decision | Substantially Equivalent, Apr 14, 1998 |
| Received | Feb 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980543
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.