Clearance Summary
Abutment Design received FDA 510(k) clearance under submission number K200100, sponsored by 3Shape A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-10-07.
- Submission: K200100
- Applicant / Sponsor: 3Shape A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2020-10-07
Classification & Regulation
This clearance is catalogued under FDA product code PNP and 21 CFR 872.3630, within the Dental review panel as a Class II device.