510(k) K974282 ยท EBF Material, Tooth Shade, Resin
VITALESCENCE
| Applicant | Ultradent Products, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Jan 29, 1998 |
| Received | Nov 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | Ultradent Products, Inc. Brand Name: Vit-l-escence
Product Name: Vit-l-escence Singles A3
Model/Catalog Number: 1203-
Software Version: N/A
Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA e Open, Classified |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.