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U.S. Department of Health and Human Services

Product Classification
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Device sterilizer, endodontic dry heat
Regulation Description Endodontic dry heat sterilizer.
Definition Call for PMAs on 4/21/97 per 62 FR 2902 on 1/21/97
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeKOK
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type PMA
Regulation Number 872.6730
Device Class 3
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 Not Third Party Eligible
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