Clearance Summary
Kit Boxes and Kit Plates received FDA 510(k) clearance under submission number K163600, sponsored by Nobel Biocare AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2018-01-22.
- Submission: K163600
- Applicant / Sponsor: Nobel Biocare AB
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2018-01-22
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.