NXV
12 FDA 510(k) clearances · Product code
90 daysmedian time to decision
133 days90th percentile
12clearances measured
FDA profile
- Official device name
- Diagnostic Light, Soft Tissue Detector
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.6350
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- FDA definition
- To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| G.o.c.c.l.e.s. (K151630) | Pierrel Pharma S.R.L. | 2015-09-15 |
| ORALID (K123169) | Forward Science, LLC | 2013-03-13 |
| MICROLUX/DL MICROLUX/BLU BIO/SCREEN (K121282) | Addent, Inc. | 2012-07-24 |
| VELSCOPE VX (K102083) | Led Dental, Inc. | 2010-11-18 |
| DENTLIGHT ORAL EXAM LIGHT KIT (K101140) | Dentlight, Inc. | 2010-07-15 |
| TRIMIRA IDENTAFI 3000 (K090135) | Remicalm, LLC | 2009-02-17 |
| BIO-SCREEN (K082668) | Addent, Inc. | 2009-01-23 |
| TRIMIRA OCS 3000 (K082603) | Remicalm, LLC | 2008-12-12 |
| VIZILITE EYEWEAR (K080043) | Zila, Inc. | 2008-04-04 |
| SAPPHIRE O/E ORAL EXAMINATION SYSTEM (K073483) | Den-Mat Holdings, LLC | 2008-04-03 |
| MODIFICATION TO: VELSCOPE (K070523) | Led Dental, Inc. | 2007-04-05 |
| VELSCOPE (K060920) | Led Medical Diagnostics, Inc. | 2006-04-27 |
Track NXV automatically
Every clearance here is in the API, with alerts when new ones post.