Hu-Friedy UI30PPSB
Hu-Friedy UI30PPSB is a Class II device made by Hu-Friedy Mfg Co., LLC, cleared under FDA 510(k) K012060 on 27 Jul 2001 and listed in FDA GUDID since 19 Dec 2020 (UDI-DI 10889950124960), 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 | Number10889950124960 | Date19 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK012060 | Date27 Jul 2001 | StatusActive |
Official records
- AccessGUDID record 10889950124960
- FDA 510(k) database K012060
Across registries
- FDA 510(k) K012060 decided 27 Jul 2001 Active
- FDA GUDID UDI-DI 10889950124960 listed 19 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K012060
- Listed FDA GUDID 10889950124960
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hu-Friedy
- Generic name
- Ultrasonic dental scaling/debridement system handpiece
- Model / Ref / Catalog
- UI30PPSB
- Primary DI / UDI-DI
- 10889950124960
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system handpiece
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Safe
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