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U.S. Department of Health and Human Services

Product Classification

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Device powder, porcelain
Regulation Description Porcelain powder for clinical use.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEIH
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.6660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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