Clearance Summary
TRAY-LINK received FDA 510(k) clearance under submission number K992001, sponsored by Silicon-Und Composite Spezialitaten 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 1999-11-02.
- Submission: K992001
- Applicant / Sponsor: Silicon-Und Composite Spezialitaten GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1999-11-02
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.