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U.S. Department of Health and Human Services

Product Classification

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Device diagnostic light, soft tissue detector
Regulation Description Ultraviolet detector.
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
Physical State The device consists of a light source with light guide cable or a handpiece based light emitting apparatus. Added components may or may not block or filter out light inundesired frequencies. The reflected light reveals tissue characteristics that are abnormal, or are suspected to be abnormal.
Technical Method The device emits a light in a specific wavelength range causing intraoral tissues to fluoresce or return or reflect light in another wavelength range in a detectable manner.
Target Area Intraoral soft tissues.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNXV
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.6350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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