Bio-Screen
by Addent, Inc.
510(k) K082668
Bio-Screen is a Class II device made by Addent, Inc., cleared under FDA 510(k) K082668 on 23 Jan 2009, active as of 10 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 | NumberK082668 | Date23 Jan 2009 | StatusActive |
Official records
- FDA 510(k) database K082668
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NXV
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6350
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K082668
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VIZILITE PRO PLS1001 | PLS1001 / PLS1001 | D813PLS10010 | On the market | |
| ViziLite® PLS1003 | PLS1003 / PLS1003 | D813PLS10030 | On the market |
Similar devices
Other devices filed under FDA product code NXV (Diagnostic Light, Soft Tissue Detector).
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- TRIMIRA OCS 3000 by Remicalm, LLC
- ORALID by Forward Science, LLC
- MODIFICATION TO: VELSCOPE by Led Dental, Inc.
- VIZILITE EYEWEAR by Zila, Inc.
- VELSCOPE VX by Led Dental, Inc.