510(k) K201795 ยท EBF Material, Tooth Shade, Resin
Transcend
| Applicant | Ultradent Product, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Sep 28, 2020 |
| Received | Jun 30, 2020 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K201795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | Ultradent Products, Inc. Brand Name: Transcend
Product Name: Transcend Econo Kit (UB) - Singles
Model/Catalog Number: 4817-
Software Version: N/A
Product Description: Transcend universal composite is a light-cured, tooth shad Open, Classified |
EBF | None listed |
| Sep 6, 2024 | Ultradent Products, Inc. Brand Name: Transcend
Product Name: Transcend Singles Universal Body (UB) Refill 10pk
Model/Catalog Number: 4757-
Software Version: N/A
Product Description: Transcend universal composite is a light-cu Open, Classified |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.