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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State viscous liquid or gel
Technical Method direct application
Target Area oral hard and soft tissue
Regulation Medical Specialty General Hospital
Review Panel Dental
Product CodeONK
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 880.6375
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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