510(k) K101485 ยท KLE Agent, Tooth Bonding, Resin
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E
| Applicant | Bisco, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, Aug 26, 2010 |
| Received | May 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101485
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.