DeviceClearance

Product code NXV— Dental

BIO-SCREEN

Classification name
Diagnostic Light, Soft Tissue Detector
Device class
Class 2
Regulation
21 CFR 872.6350
Advisory panel
Dental
Total cleared
12
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code NXV under 21 CFR 872.6350, via openFDA

Market context for product code NXV

FDA has cleared 12 devices under product code NXV between 2006 and 2015, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NXV

Recent clearances under product code NXV

Data sourced from openFDA. This site is unofficial and independent of the FDA.