Amelogen Plus 8019
by Ultradent Products, Inc. 2 variants
Amelogen Plus 8019 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K043119 on 17 Dec 2004 and listed in FDA GUDID since 22 Aug 2023 (UDI-DI 00883205037046), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00883205037046 | Date22 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK043119 | Date17 Dec 2004 | StatusActive |
Official records
- AccessGUDID record 00883205037046
- FDA 510(k) database K043119
Across registries
- FDA 510(k) K043119 decided 17 Dec 2004 Active
- FDA GUDID UDI-DI 00883205037046 listed 22 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K043119
- Listed FDA GUDID 00883205037046
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Amelogen Plus
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- 8019
- Primary DI / UDI-DI
- 00883205037046
- 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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