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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oral lubricant
Regulation Description Patient lubricant.
Definition An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.
Product CodeONK
Regulation Number 880.6375
Device Class 1