Clearance Summary
RN SYNOCTA TEMPORARY MESO ABUTMENT received FDA 510(k) clearance under submission number K051717, sponsored by Institut Straumann SA. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-07-07.
- Submission: K051717
- Applicant / Sponsor: Institut Straumann SA
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2005-07-07
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.