SABLE Access II 2000003
SABLE Access II 2000003 is a Class I device made by Sable Industries Inc, cleared under FDA 510(k) K072554 on 14 Nov 2007 and listed in FDA GUDID since 4 Jul 2022 (UDI-DI 00841359010018), 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 | Number00841359010018 | Date4 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK072554 | Date14 Nov 2007 | StatusActive |
Official records
- AccessGUDID record 00841359010018
- FDA 510(k) database K072554
Across registries
- FDA 510(k) K072554 decided 14 Nov 2007 Active
- FDA GUDID UDI-DI 00841359010018 listed 4 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K072554
- Listed FDA GUDID 00841359010018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SABLE Access II
- Generic name
- Dental surgical power tool motorized handpiece/set, pneumatic
- Model / reference
- 2000003
- Primary DI / UDI-DI
- 00841359010018
- 510(k) Number
- FDA product code
- EFB
- GMDN term
- Dental surgical power tool motorized handpiece/set, pneumatic
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental surgical power tool motorized handpiece/set, pneumatic.