510(k) K101717 ยท EFB Handpiece, Air-Powered, Dental
DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING
| Applicant | Aerobine, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 20, 2010 |
| Received | Jun 18, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101717
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.