Clearance Summary
ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND received FDA 510(k) clearance under submission number K921044, sponsored by Wallace A. Erickson & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1992-11-09.
- Submission: K921044
- Applicant / Sponsor: Wallace A. Erickson & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3750
- Decision date: 1992-11-09
Classification & Regulation
This clearance is catalogued under FDA product code DYH and 21 CFR 872.3750, within the Dental review panel as a Class II device.