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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
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

MDR Year MDR Reports MDR Events
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 1 1