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U.S. Department of Health and Human Services

Product Classification
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Device intraoral cooling device
Definition An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces
Physical State A removable mouthpiece that contains a liquid or solid coolant at freezing or near freezing temperatures
Technical Method The mouthpiece exhibits cooling technology that allows for heat transfer between the mouthpiece and the oral mucosa thereby cooling the oral mucosa
Target Area Oral Mucosa in the mouth
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeQUA
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5590
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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