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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device denture repair kit
Regulation Description OTC denture repair kit.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeEBO
Regulation Number 872.3570
Device Class 2

Device Problems
Missing Value Reason 1
Total Device Problems 1


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