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U.S. Department of Health and Human Services

Product Classification

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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.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNTO
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5580
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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