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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
Product CodeNXV
Regulation Number 872.6350
Device Class 2


Premarket Reviews
ManufacturerDecision
REMICALM, LLC
  SUBSTANTIALLY EQUIVALENT 2

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