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Oral Lubricant

FDA product code ONK · 1 cleared devices

Class 1 General Hospital
Regulation
21 CFR 880.6375
Review panel
DE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2009-05-21 – 2009-05-21

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.

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