Vit-l-escence 418
Vit-l-escence 418 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 00883205105646), 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 | Number00883205105646 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK974282 | Date29 Jan 1998 | StatusActive |
Official records
- AccessGUDID record 00883205105646
- FDA 510(k) database K974282
Across registries
- FDA 510(k) K974282 decided 29 Jan 1998 Active
- FDA GUDID UDI-DI 00883205105646 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 00883205105646
- 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- Withdrawn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
- 418
- Primary DI / UDI-DI
- 00883205105646
- 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
Similar devices in this category
Other devices filed under Dental composite resin.
- SYNERGY D6 8378 by Coltène/Whaledent AG
- DenFil DF104-RA11 by VERICOM CO., LTD.
- Harvard Temp Cem 7081200 by Harvard Dental International GmbH
- SYNERGY D6 8380 by Coltène/Whaledent AG
- REFLECTYS A2O CP CPTYS-A2O by ITENA CLINICAL
- Nexcomp flow B3 9252 by Meta Biomed Co., Ltd.
- Bifix SE 1787 by VOCO GmbH
- DENTOCORE Cartridge white shade DCB-50 by ITENA CLINICAL
- VisCalor bulk 6066 by VOCO GmbH
- Nexcomp flow A3 9247 by Meta Biomed Co., Ltd.