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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rinse, oral, antibacterial (by physical means)
Regulation Description Oral rinse to reduce the adhesion of dental plaque.
Definition Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.
Product CodeNTO
Regulation Number 872.5580
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 1 1
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Complaint, Ill-Defined 2 2
Shaking/Tremors 1 1
Anaphylactoid 1 1

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