Clearance Summary
PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE received FDA 510(k) clearance under submission number K912171, sponsored by Jack James. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-08-13.
- Submission: K912171
- Applicant / Sponsor: Jack James
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 1991-08-13
Classification & Regulation
This clearance is catalogued under FDA product code EJF and 21 CFR 872.5410, within the Dental review panel as a Class I device.