OAJ · Class I — Low Risk (general controls) · General, Plastic Surgery · 21 CFR 878.4200
Classification
FDA Product Code
OAJ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 878.4200
Review panel
DE
Medical specialty
General, Plastic Surgery
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones