MECTRON MANIPOLO PIEZOSURGERY® medical +
by Mectron SpA
MECTRON MANIPOLO PIEZOSURGERY® medical + (03120249-001) is a Class II device made by Mectron SpA, cleared under FDA 510(k) K153743 on 25 May 2016 and listed in FDA GUDID since 16 Jun 2025 (UDI-DI E322031202490010), 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 | NumberE322031202490010 | Date16 Jun 2025 | StatusListed |
| United States | FDA 510(k) | NumberK153743 | Date25 May 2016 | StatusActive |
Official records
- FDA 510(k) database K153743
Across registries
- FDA 510(k) K153743 decided 25 May 2016 Active
- FDA GUDID UDI-DI E322031202490010 listed 16 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K153743
- Listed FDA GUDID E322031202490010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mectron
- Generic name
- Dental ultrasonic surgical system handpiece
- Model / Ref / Catalog
- MANIPOLO PIEZOSURGERY® medical +, 03120249-001
- Primary DI / UDI-DI
- E322031202490010
- 510(k) Number
- FDA product code
- DZI, HWE, HBE, ERL, JDX
- GMDN term
- Dental ultrasonic surgical system handpiece
- Device class
- Class II
- Regulation number
- 872.4120, 878.4820, 882.4310, 874.4250, 888.4580
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization