510(k) K010547 ยท KLE Agent, Tooth Bonding, Resin
VERTEX SEALAND L/C ORTHODONTIC SEALANT
| Applicant | Apex Dental Materials, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, Aug 16, 2001 |
| Received | Feb 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010547
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.