Clearance Summary
DTI-1 SLA IMPLANT SYSTEM received FDA 510(k) clearance under submission number K170776, sponsored by Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-04-10.
- Submission: K170776
- Applicant / Sponsor: Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2018-04-10
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.