510(k) K192412 ยท EFB Handpiece, Air-Powered, Dental
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
| Applicant | Dentalez, Inc., Lancaster PA, US |
| Decision | Substantially Equivalent, Jan 6, 2020 |
| Received | Sep 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192412
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.