510(k) K013647 ยท EBF Material, Tooth Shade, Resin
REVOLUTION FORMULA 2
| Applicant | Sybron Dental Specialties, Inc., Orange CA, US |
| Decision | Substantially Equivalent, Jan 16, 2002 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013647
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2010 | Patterson Dental Supply, Inc. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493.
SDS Kerr Revolution Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.