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U.S. Department of Health and Human Services

Product Classification
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Device pad, denture, over the counter
Regulation Description OTC denture cushion or pad.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEHR
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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