510(k) K042614 ยท KLE Agent, Tooth Bonding, Resin
S&C-SELF ETCH PR-BOND
| Applicant | S & C Polymer GmbH, Elmshorn, DE |
| Decision | Substantially Equivalent, Nov 22, 2004 |
| Received | Sep 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042614
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2014 | Novocol, Inc. Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure
Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert. Terminated |
KLE | None listed |
| Jul 29, 2014 | Novocol, Inc. Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 Terminated |
KLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.