FDA Product Code LYC: Bone Grafting Material, Synthetic
A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.
Leading manufacturers include Shenzhen Dazhou Medical Technology Co., Ltd., Full Golden Biotech Corporation and Full Golden Biotech Co., Ltd..
FDA 510(k) Cleared Bone Grafting Material, Synthetic Devices (Product Code LYC)
About Product Code LYC - Regulatory Context
510(k) Submission Activity
229 total 510(k) submissions under product code LYC since 1979, with 229 receiving FDA clearance (average review time: 168 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LYC have taken an average of 274 days to reach a decision - up from 166 days historically. Manufacturers should account for longer review timelines in current project planning.
LYC devices are reviewed by the Dental panel. Browse all Dental devices →