510(k) K971606 ยท EFA Handpiece, Belt And/Or Gear Driven, Dental
STERILE FLEXOFILE FILES AND INSTRUMENTS
| Applicant | Dentsply Intl., York PA, US |
| Decision | Substantially Equivalent, Jun 3, 1997 |
| Received | May 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971606
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.