Clearance Summary
Nucleoss T6 Dental Implant System received FDA 510(k) clearance under submission number K192062, sponsored by Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-08-27.
- Submission: K192062
- Applicant / Sponsor: Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2020-08-27
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.