Valo, Model 5919
510(k) K083647
Valo, Model 5919 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K083647 on 23 Jan 2009, 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 | FDA 510(k)SESE | NumberK083647 | Date23 Jan 2009 | StatusActive |
Official records
- FDA 510(k) database K083647
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBZ
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6070
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent