510(k) K130137 ยท ELC Scaler, Ultrasonic
BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER
| Applicant | Coltene/Whaledent, Cleveland OH, US |
| Decision | Substantially Equivalent, Aug 23, 2013 |
| Received | Jan 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130137
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.