# Diagnostic Light, Soft Tissue Detector
> **Product code: NXV** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.6350
## Classification
- **FDA Product Code:** NXV
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.6350
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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

## Market data
- **Cleared 510(k) submissions:** 12
- **Registered establishments:** 6
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NXV)
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