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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
Submission Type PMA
Regulation Number 872.6730
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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