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U.S. Department of Health and Human Services

Product Classification
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Device crown and bridge material, resin based
Definition Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications.
Physical State Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications
Technical Method Used for dental crown restorations by single crown, bridge, etc, or for indirect repair of dental crown fabrications
Target Area Tooth
Review Panel Dental
Product CodePKJ
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
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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