QJJ — Indirect Bonding Tray Class I
FDA product code QJJ covers "Indirect Bonding Tray", a Class I medical device regulated under 21 CFR 872.5410. Submissions are reviewed by the Dental panel.
Classification Details
- Product Code
- QJJ
- Device Class
- Class I
- Regulation Number
- 872.5410
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces.