510(k) K100647 ยท ELC Scaler, Ultrasonic
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
| Applicant | A-Dec, Inc., Newberg OR, US |
| Decision | Substantially Equivalent, Jul 9, 2010 |
| Received | Mar 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100647
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.