A-dec 54.1041.00
by A-Dec, Inc.
A-dec 54.1041.00 is a Class II device made by A-Dec, Inc., cleared under FDA 510(k) K182712 on 23 Nov 2019 and listed in FDA GUDID since 11 Feb 2025 (UDI-DI 10194665007928), 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 | Number10194665007928 | Date11 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182712 | Date23 Nov 2019 | StatusActive |
Official records
- AccessGUDID record 10194665007928
- FDA 510(k) database K182712
Across registries
- FDA 510(k) K182712 decided 23 Nov 2019 Active
- FDA GUDID UDI-DI 10194665007928 listed 11 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K182712
- Listed FDA GUDID 10194665007928
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- A-dec
- Generic name
- Intraoral camera
- Model / Ref / Catalog
- 54.1041.00
- Primary DI / UDI-DI
- 10194665007928
- 510(k) Number
- FDA product code
- NTK
- GMDN term
- Intraoral camera
- Device class
- Class II
- Regulation number
- 872.1745
- GUDID distribution status
- In Commercial Distribution
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