510(k) K063558 ยท KLE Agent, Tooth Bonding, Resin
PEAK SE, MODEL 5135
| Applicant | Ultradent Products, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Dec 14, 2006 |
| Received | Nov 27, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063558
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2022 | Ultradent Products, Inc. Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill, Part: 5135; Peak Universal Bond Sample SE, Part: S4554. For use i Completed |
KLE | None listed |
| Jun 18, 2012 | Ultradent Products, Inc. Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plas Terminated |
KLE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.