Mectron RD4 + K10
by Mectron SpA
Mectron RD4 + K10 (03050007-001) 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 3 Mar 2023 (UDI-DI E322030500070010), 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 | NumberE322030500070010 | Date3 Mar 2023 | 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 E322030500070010 listed 3 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K140965
- Listed FDA GUDID E322030500070010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mectron
- Generic name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic
- Model / Ref / Catalog
- RD4 + K10, 03050007-001
- Primary DI / UDI-DI
- E322030500070010
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization