Product code NXV

Device name

Diagnostic Light, Soft Tissue Detector

Medical specialty

Dental

Device class

2

Regulation number

872.6350

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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

Source

FDA openFDA device classification dataset