Clearance Summary
S & C -BRACKET ADHESIVES received FDA 510(k) clearance under submission number K031420, sponsored by S & C Polymer GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2003-08-20.
- Submission: K031420
- Applicant / Sponsor: S & C Polymer GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3750
- Decision date: 2003-08-20
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.