Piezon Fs-307
by E.M.S. Electro Medical Systems S.A.
Piezon Fs-307 is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K072146 on 18 Dec 2007 and listed in FDA GUDID since 19 Mar 2020 (UDI-DI 07613353196318), 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 | Number07613353196318 | Date19 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK072146 | Date18 Dec 2007 | StatusActive |
Official records
- AccessGUDID record 07613353196318
- FDA 510(k) database K072146
Across registries
- FDA 510(k) K072146 decided 18 Dec 2007 Active
- FDA GUDID UDI-DI 07613353196318 listed 19 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K072146
- Listed FDA GUDID 07613353196318
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Piezon
- Generic name
- Dental ultrasonic surgical system handpiece
- Model / reference
- FS-307
- Primary DI / UDI-DI
- 07613353196318
- 510(k) Number
- FDA product code
- DZI
- GMDN term
- Dental ultrasonic surgical system handpiece
- Device class
- Class II
- Regulation number
- 872.4120
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization