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U.S. Department of Health and Human Services

Product Classification

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Device oral wound dressing w/drug and/or biologic
Definition Intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. Unclassified status per se to mgq.
Physical State A viscous liquid or gel
Technical Method Supplied as an oral rinse or as a gel, liquid or patch to be directly applied to an oral wound.
Target Area Oral mucosal tissue
Review Panel Dental
Product CodeOLS
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible