A-dec 54.0875.00
by A-Dec, Inc.
A-dec 54.0875.00 is a Class I device made by A-Dec, Inc., cleared under FDA 510(k) K130560 on 27 Sep 2013 and listed in FDA GUDID since 7 Nov 2022 (UDI-DI 10194665004477), 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 | Number10194665004477 | Date7 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130560 | Date27 Sep 2013 | StatusActive |
Official records
- AccessGUDID record 10194665004477
- FDA 510(k) database K130560
Across registries
- FDA 510(k) K130560 decided 27 Sep 2013 Active
- FDA GUDID UDI-DI 10194665004477 listed 7 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K130560
- Listed FDA GUDID 10194665004477
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- A-dec
- Generic name
- Pneumatic dental power tool system handpiece tip, reusable
- Model / Ref / Catalog
- 54.0875.00
- Primary DI / UDI-DI
- 10194665004477
- 510(k) Number
- FDA product code
- EFB
- GMDN term
- Pneumatic dental power tool system handpiece tip, reusable
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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