Clearance Summary
CURA-Temp received FDA 510(k) clearance under submission number K202965, sponsored by Mgnewton , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-12-21.
- Submission: K202965
- Applicant / Sponsor: Mgnewton , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2022-12-21
Classification & Regulation
This clearance is catalogued under FDA product code EBG and 21 CFR 872.3770, within the Dental review panel as a Class II device.