510(k) K100539 ยท EJR Agent, Polishing, Abrasive, Oral Cavity
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
| Applicant | Preventive Technologies, Inc., Indian Trial NC, US |
| Decision | Substantially Equivalent, Jun 17, 2010 |
| Received | Feb 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100539
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.