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U.S. Department of Health and Human Services

Product Classification

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Device cement, ear, nose and throat
Regulation Description Dental cement.
Regulation Medical Specialty Dental
Review Panel Ear Nose & Throat
Product CodeNEA
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 872.3275
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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