510(k) K052501 ยท KLE Agent, Tooth Bonding, Resin
MULTIPLE RESIN TOOTH BONDING AGENT
| Applicant | Cosmedent, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Oct 21, 2005 |
| Received | Sep 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052501
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2017 | Cosmedent, Inc. Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes.
Used for etching enamel and dentin. Terminated |
KLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.