PIEZO Tip BE-2
PIEZO Tip BE-2 is an ultrasonic dental scaling/debridement system (FDA Class II; FDA product code ELC, Scaler, Ultrasonic) made by Bonart Co., Ltd., cleared under FDA 510(k) K071981 on 26 Oct 2007 and listed in FDA GUDID since 27 Apr 2018 (UDI-DI 04719873121120), active as of 21 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 | Number04719873121120 | Date27 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071981 | Date26 Oct 2007 | StatusActive |
Official records
- AccessGUDID record 04719873121120
- FDA 510(k) database K071981
Across registries
- FDA 510(k) K071981 decided 26 Oct 2007 Active
- FDA GUDID UDI-DI 04719873121120 listed 27 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K071981
- Listed FDA GUDID 04719873121120
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Ultrasonic dental scaling/debridement system
- Model / reference
- BE-2
- Primary DI / UDI-DI
- 04719873121120
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Ultrasonic dental scaling/debridement system.