Alpha-Core® DC 122.0003.002
Alpha-Core® DC 122.0003.002 is a Class II device made by Dental Technologies, Inc., cleared under FDA 510(k) K070191 on 7 Mar 2007 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI D73512200030020), 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 | NumberD73512200030020 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK070191 | Date7 Mar 2007 | StatusActive |
Official records
- FDA 510(k) database K070191
Across registries
- FDA 510(k) K070191 decided 7 Mar 2007 Active
- FDA GUDID UDI-DI D73512200030020 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K070191
- Listed FDA GUDID D73512200030020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alpha-Core® DC
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- 122.0003.002
- Primary DI / UDI-DI
- D73512200030020
- 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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