510(k) K243280 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
| Applicant | W&H Dentalwerk Buermoos GmbH, Buermoos, AT |
| Decision | Substantially Equivalent, Jul 3, 2025 |
| Received | Oct 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243280
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.