Clearance Summary
Membrane Screws and Membrane Tacks received FDA 510(k) clearance under submission number K201561, sponsored by Neoss Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-10-05.
- Submission: K201561
- Applicant / Sponsor: Neoss Limited
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4880
- Decision date: 2020-10-05
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.