Acteon Newt Booster Hp Newt. Us KITV4
by Satelec
Acteon Newt Booster Hp Newt. Us KITV4 (F60211) is a Class II device made by Satelec, cleared under FDA 510(k) K131997 on 26 Nov 2013 and listed in FDA GUDID since 24 Dec 2019 (UDI-DI 03609820602110), 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 | Number03609820602110 | Date24 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131997 | Date26 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 03609820602110
- FDA 510(k) database K131997
Across registries
- FDA 510(k) K131997 decided 26 Nov 2013 Active
- FDA GUDID UDI-DI 03609820602110 listed 24 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K131997
- Listed FDA GUDID 03609820602110
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acteon
- Generic name
- Ultrasonic dental scaling/debridement system
- Model / Ref / Catalog
- NEWT BOOSTER HP NEWT. US KITV4, F60211
- Description
- Automatic power regulation and perfectly controlled vibrations with the NEWTRON® technology Increased tactile sense for the practitioner.
- Primary DI / UDI-DI
- 03609820602110
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under Ultrasonic dental scaling/debridement system.