510(k) K983183 ยท EFB Handpiece, Air-Powered, Dental
GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
| Applicant | Bien Air USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 10, 1998 |
| Received | Sep 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983183
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.