Clearance Summary
3Shape Splint Design received FDA 510(k) clearance under submission number K191911, 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 2019-11-27.
- Submission: K191911
- Applicant / Sponsor: 3Shape A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2019-11-27
Classification & Regulation
This clearance is catalogued under FDA product code PNN and 21 CFR 872.5470, within the Dental review panel as a Class II device.