Mectron D1 + K10
by Mectron SpA
Mectron D1 + K10 (02990001-001) is a Class II device made by Mectron SpA, cleared under FDA 510(k) K140965 on 20 Aug 2014 and listed in FDA GUDID since 11 Sep 2019 (UDI-DI E322029900010010), 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 | NumberE322029900010010 | Date11 Sep 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140965 | Date20 Aug 2014 | StatusActive |
Official records
- FDA 510(k) database K140965
Across registries
- FDA 510(k) K140965 decided 20 Aug 2014 Active
- FDA GUDID UDI-DI E322029900010010 listed 11 Sep 2019 Listed
Timeline
- Cleared FDA 510(k) K140965
- Listed FDA GUDID E322029900010010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mectron
- Generic name
- Ultrasonic dental scaling/debridement system
- Model / Ref / Catalog
- D1 + K10, 02990001-001
- Primary DI / UDI-DI
- E322029900010010
- 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
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Ultrasonic dental scaling/debridement system.