Dental Basics BE12
Dental Basics BE12 is a Class II device made by Dental Basics Inc., cleared under FDA 510(k) K163447 on 20 Jun 2017 and listed in FDA GUDID since 8 May 2024 (UDI-DI 00850061028044), active as of 22 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 | Number00850061028044 | Date8 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163447 | Date20 Jun 2017 | StatusActive |
Official records
- AccessGUDID record 00850061028044
- FDA 510(k) database K163447
Across registries
- FDA 510(k) K163447 decided 20 Jun 2017 Active
- FDA GUDID UDI-DI 00850061028044 listed 8 May 2024 Listed
Timeline
- Cleared FDA 510(k) K163447
- Listed FDA GUDID 00850061028044
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dental Basics
- Generic name
- Digital imaging cassette
- Model / reference
- BE12
- Primary DI / UDI-DI
- 00850061028044
- 510(k) Number
- FDA product code
- PEM
- GMDN term
- Digital imaging cassette
- Device class
- Class II
- Regulation number
- 878.4370
- GUDID distribution status
- In Commercial Distribution
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