Mectron PD0328A -Us-
by Mectron SpA
Mectron PD0328A -Us- (04800003-101) is a Class II device made by Mectron SpA, cleared under FDA 510(k) K242432 on 19 Aug 2024 and listed in FDA GUDID since 15 Oct 2024 (UDI-DI E322048000031010), 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 | NumberE322048000031010 | Date15 Oct 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242432 | Date19 Aug 2024 | StatusActive |
Official records
- FDA 510(k) database K242432
Across registries
- FDA 510(k) K242432 decided 19 Aug 2024 Active
- FDA GUDID UDI-DI E322048000031010 listed 15 Oct 2024 Listed
Timeline
- Cleared FDA 510(k) K242432
- Listed FDA GUDID E322048000031010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mectron
- Generic name
- Dental ultrasonic surgical system handpiece tip
- Model / Ref / Catalog
- PD0328A -US-, 04800003-101
- Primary DI / UDI-DI
- E322048000031010
- 510(k) Number
- FDA product code
- DZI, ELC
- GMDN term
- Dental ultrasonic surgical system handpiece tip
- Device class
- Class II
- Regulation number
- 872.4120, 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization