Clearance Summary
VarseoSmile Temp received FDA 510(k) clearance under submission number K193553, sponsored by Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-05-18.
- Submission: K193553
- Applicant / Sponsor: Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3770
- Decision date: 2020-05-18
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.