Comfort-Sonic UL2218
Comfort-Sonic UL2218 (K-61) is a Class II device made by Beyes Dental Canada Inc, cleared under FDA 510(k) K053555 on 21 Aug 2006 and listed in FDA GUDID since 19 Jan 2024 (UDI-DI 00990010306691), active as of 22 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 | Number00990010306691 | Date19 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053555 | Date21 Aug 2006 | StatusActive |
Official records
- AccessGUDID record 00990010306691
- FDA 510(k) database K053555
Across registries
- FDA 510(k) K053555 decided 21 Aug 2006 Active
- FDA GUDID UDI-DI 00990010306691 listed 19 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K053555
- Listed FDA GUDID 00990010306691
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Comfort-Sonic
- Generic name
- Ultrasonic dental scaling/debridement system
- Model / Ref / Catalog
- UL2218, K-61
- Primary DI / UDI-DI
- 00990010306691
- 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
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Ultrasonic dental scaling/debridement system.