ONK · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6375
Classification
FDA Product Code
ONK
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.6375
Review panel
DE
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.