Clearance Summary
MC BIO Supertack Tack 3mm, 4mm and 5mm received FDA 510(k) clearance under submission number K151540, sponsored by Eli-Ka Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-05-26.
- Submission: K151540
- Applicant / Sponsor: Eli-Ka Technologies
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 2016-05-26
Classification & Regulation
This clearance is catalogued under FDA product code DZL and 21 CFR 872.4880, within the Dental review panel as a Class II device.