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