Clearance Summary
PREMIUM Implant Systems SHELTA Implant Systems received FDA 510(k) clearance under submission number K161989, sponsored by Sweden & Martina S.P.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2018-02-01.
- Submission: K161989
- Applicant / Sponsor: Sweden & Martina S.P.A.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2018-02-01
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.