QJK — Intraoral Camera Class II

FDA Device Classification

FDA product code QJK covers "Intraoral Camera", a Class II medical device regulated under 21 CFR 872.3661. Submissions are reviewed by the Dental panel.

Classification Details

Product Code
QJK
Device Class
Class II
Regulation Number
872.3661
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Definition

To capture the topographical characteristics of teeth or a stone model