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U.S. Department of Health and Human Services

Product Classification

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Device crown & 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 Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Not Classified Reason For Export Only
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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