Mectron Icp -Us
by Mectron SpA
Mectron Icp -Us (03570003-101) is a Class II device made by Mectron SpA, cleared under FDA 510(k) K151248 on 4 Sep 2015 and listed in FDA GUDID since 3 Sep 2026 (UDI-DI E322035700031010), 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 | NumberE322035700031010 | Date3 Sep 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151248 | Date4 Sep 2015 | StatusActive |
Official records
- FDA 510(k) database K151248
Across registries
- FDA 510(k) K151248 decided 4 Sep 2015 Active
- FDA GUDID UDI-DI E322035700031010 listed 3 Sep 2026 Listed
Timeline
- Cleared FDA 510(k) K151248
- Listed FDA GUDID E322035700031010
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- Withdrawn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
- ICP -US, 03570003-101
- Primary DI / UDI-DI
- E322035700031010
- 510(k) Number
- FDA product code
- ELC, DZI
- GMDN term
- Dental ultrasonic surgical system handpiece tip
- Device class
- Class II
- Regulation number
- 872.4850, 872.4120
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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