Clearance Summary
ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 received FDA 510(k) clearance under submission number K984503, 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 1999-02-26.
- Submission: K984503
- Applicant / Sponsor: Wallace A. Erickson & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 1999-02-26
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.