DENTRIα Series DENTRI-Cα
DENTRIα Series DENTRI-Cα is a Class II device made by Hdx Will Corp., cleared under FDA 510(k) K160140 on 30 Sep 2016 and listed in FDA GUDID since 25 Dec 2016 (UDI-DI 08800005200038), 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 | Number08800005200038 | Date25 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160140 | Date30 Sep 2016 | StatusActive |
Official records
- AccessGUDID record 08800005200038
- FDA 510(k) database K160140
Across registries
- FDA 510(k) K160140 decided 30 Sep 2016 Active
- FDA GUDID UDI-DI 08800005200038 listed 25 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K160140
- Listed FDA GUDID 08800005200038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DENTRIα Series
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / reference
- DENTRI-Cα
- Primary DI / UDI-DI
- 08800005200038
- 510(k) Number
- FDA product code
- OAS
- GMDN term
- Stationary panoramic/tomographic dental x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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