Acteon Handpiece Newtron Slim 54.0580.00
by Satelec
Acteon Handpiece Newtron Slim 54.0580.00 (F12916) is a Class II device made by Satelec, cleared under FDA 510(k) K132322 on 11 Mar 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 03609820129167), 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 | Number03609820129167 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132322 | Date11 Mar 2014 | StatusActive |
Official records
- AccessGUDID record 03609820129167
- FDA 510(k) database K132322
Across registries
- FDA 510(k) K132322 decided 11 Mar 2014 Active
- FDA GUDID UDI-DI 03609820129167 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K132322
- Listed FDA GUDID 03609820129167
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acteon
- Generic name
- Ultrasonic dental scaling/debridement system handpiece
- Model / Ref / Catalog
- HANDPIECE NEWTRON SLIM 54.0580.00, F12916
- Primary DI / UDI-DI
- 03609820129167
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system handpiece
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization