Clearance Summary
BEL-CYPHER, MODEL Y977 received FDA 510(k) clearance under submission number K090020, sponsored by Takara-Belmont Co., 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 2009-03-13.
- Submission: K090020
- Applicant / Sponsor: Takara-Belmont Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2009-03-13
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.