Cavitron® 80395
Cavitron® 80395 is a Class II device made by Dentsply Professional, listed in FDA GUDID since 23 Sep 2016 (UDI-DI D003803951), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD003803951 | Date23 Sep 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Cavitron®
- Generic name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal
- Model / reference
- 80395
- Description
- FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K FSI®-SLI®-10S
- Primary DI / UDI-DI
- D003803951
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization