Clearance Summary
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 received FDA 510(k) clearance under submission number K221955, sponsored by Realcloud Imaging Inc. Dba Realcloud Imaging. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-08-31.
- Submission: K221955
- Applicant / Sponsor: Realcloud Imaging Inc. Dba Realcloud Imaging
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2022-08-31
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.