Varios E7
Varios E7 is a Class II device made by Nakanishi Inc., cleared under FDA 510(k) K113530 on 31 Jan 2013 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04560264563377), 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 | Number04560264563377 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113530 | Date31 Jan 2013 | StatusActive |
Official records
- AccessGUDID record 04560264563377
- FDA 510(k) database K113530
Across registries
- FDA 510(k) K113530 decided 31 Jan 2013 Active
- FDA GUDID UDI-DI 04560264563377 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K113530
- Listed FDA GUDID 04560264563377
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Varios
- Generic name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic
- Model / reference
- E7
- Primary DI / UDI-DI
- 04560264563377
- 510(k) Number
- FDA product code
- ELC
- GMDN term
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic
- Device class
- Class II
- Regulation number
- 872.4850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization