DENTRI Max DENTRIα
DENTRI Max DENTRIα is a Class II device made by Hdx Will Corp., cleared under FDA 510(k) K212254 on 19 Oct 2021 and listed in FDA GUDID since 29 Apr 2022 (UDI-DI 08800005200410), 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 | Number08800005200410 | Date29 Apr 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212254 | Date19 Oct 2021 | StatusActive |
Official records
- AccessGUDID record 08800005200410
- FDA 510(k) database K212254
Across registries
- FDA 510(k) K212254 decided 19 Oct 2021 Active
- FDA GUDID UDI-DI 08800005200410 listed 29 Apr 2022 Listed
Timeline
- Cleared FDA 510(k) K212254
- Listed FDA GUDID 08800005200410
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DENTRI Max
- Generic name
- Stationary panoramic/tomographic dental x-ray system, digital
- Model / reference
- DENTRIα
- Primary DI / UDI-DI
- 08800005200410
- 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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