Clearance Summary
PROLINK ADHESIVES (PROLINK, PROLINK SE) received FDA 510(k) clearance under submission number K110403, sponsored by Silmet , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-09-08.
- Submission: K110403
- Applicant / Sponsor: Silmet , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2011-09-08
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.