Vit-l-escence 435
Vit-l-escence 435 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K974282 on 29 Jan 1998 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205105691), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00883205105691 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK974282 | Date29 Jan 1998 | StatusActive |
Official records
- AccessGUDID record 00883205105691
- FDA 510(k) database K974282
Across registries
- FDA 510(k) K974282 decided 29 Jan 1998 Active
- FDA GUDID UDI-DI 00883205105691 listed 22 Sep 2016 Listed
Recalls
-
- Ongoing Z-3066-2024
Due to a manufacturing issue, red particulates present in the expressed composite.
Timeline
- Cleared FDA 510(k) K974282
- Listed FDA GUDID 00883205105691
- Recall initiated FDA recalls Z-3066-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vit-l-escence
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- 435
- Primary DI / UDI-DI
- 00883205105691
- 510(k) Number
- FDA product code
- EBF
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3690
- GUDID distribution status
- In Commercial Distribution
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