Art-M3II Pro
Art-M3II Pro is a Class II device made by Bonart Co., Ltd., cleared under FDA 510(k) K081550 on 28 Aug 2008 and listed in FDA GUDID since 27 Apr 2026 (UDI-DI 04719873121861), 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 | Number04719873121861 | Date27 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081550 | Date28 Aug 2008 | StatusActive |
Official records
- AccessGUDID record 04719873121861
- FDA 510(k) database K081550
Across registries
- FDA 510(k) K081550 decided 28 Aug 2008 Active
- FDA GUDID UDI-DI 04719873121861 listed 27 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K081550
- Listed FDA GUDID 04719873121861
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Art
- Generic name
- Ultrasonic dental scaling/debridement system
- Model / reference
- ART-M3II PRO
- Primary DI / UDI-DI
- 04719873121861
- 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
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