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U.S. Department of Health and Human Services

Product Classification

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Device cushion, denture, over the counter
Regulation Description OTC denture cushion or pad.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEHS
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 872.3540
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; Final
Third Party Review
Accredited Persons

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