Clearance Summary
Evogue Dental Unit received FDA 510(k) clearance under submission number K152100, sponsored by Takara Belmont Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2016-01-22.
- Submission: K152100
- Applicant / Sponsor: Takara Belmont Corporation
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2016-01-22
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.