510(k) K102053 ยท EJR Agent, Polishing, Abrasive, Oral Cavity
BUTLER CALCI-FLOR PROPHYLAXIS PASTE
| Applicant | Sunstar Americas, Inc., Lake Bluff IL, US |
| Decision | Substantially Equivalent, Feb 3, 2011 |
| Received | Jul 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102053
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.