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Diagnostic Light, Soft Tissue Detector

FDA product code NXV · 11 cleared devices

Class 2 Dental
Regulation
21 CFR 872.6350
Review panel
DE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2006-04-27 – 2013-03-13

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

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