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U.S. Department of Health and Human Services

Product Classification

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Device material, tooth shade, resin
Regulation Description Tooth shade resin material.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEBF
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 872.3690
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff
Third Party Review
Accredited Persons

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