Clearance Summary
BONE PLUS BCP EAGLE EYE received FDA 510(k) clearance under submission number K122240, sponsored by Megagen Implant Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-08-21.
- Submission: K122240
- Applicant / Sponsor: Megagen Implant Co., Ltd.
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2012-08-21
Classification & Regulation
This clearance is catalogued under FDA product code LYC and 21 CFR 872.3930, within the Dental review panel as a Class II device.