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 Biomet, Inc., Depuy, Inc. and GC America, Inc..
230
Total
230
Cleared
168d
Avg days
1979
Since
Growing category -
5 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
251d
recently vs 166d historically
FDA 510(k) Cleared Bone Grafting Material, Synthetic Devices (Product Code LYC)
230 devices
Cleared
May 14, 2026
Bonalive Maxillofacial
Bonalive , Ltd.
Dental
161d
Cleared
Mar 06, 2026
BONTREE PLUS
Hudens Bio Co., Ltd.
Dental
266d
Cleared
Sep 17, 2025
FG Bone Graft M
Full Golden Biotech Co., Ltd.
Dental
265d
Cleared
Aug 29, 2025
FG Bone Graft B
Full Golden Biotech Corporation
Dental
267d
Cleared
Feb 21, 2025
Synthetic Bone Graft Particulate
Shenzhen Dazhou Medical Technology Co., Ltd.
Dental
298d
Cleared
Dec 30, 2022
CMFlexTM
Dimension Inx Corp.
Dental
456d
Cleared
Mar 04, 2022
InRoad® Dental Synthetic Bone Graft
Osteogene Tech Corp
Dental
535d
Cleared
Oct 02, 2020
OsOpia Synthetic Bone Void Filler
Revisios BV
Dental
115d
Cleared
Sep 24, 2020
Straumann BoneCeramic
Institut Straumann AG
Dental
156d
Cleared
Aug 17, 2020
Cytrans Granules
GC America, Inc.
Dental
332d
Cleared
Aug 06, 2008
TRICOS A RESORBABLE SUBSTITUTE
Baxter Healthcare Corp
Dental
49d
Cleared
Jan 23, 2006
SYNTHES (USA) CHRONOS-BETA-TCP
Synthes (Usa)
Dental
89d
Cleared
Apr 09, 2001
MIMIX BONE REPLACEMENT SYSTEM
Biomet, Inc.
Dental
147d
Cleared
Feb 09, 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
Biomet, Inc.
Dental
88d
Cleared
Apr 03, 1998
ENDOBON
Biomet, Inc.
Dental
42d
Cleared
Nov 07, 1984
HYDROXYAPATITE
Depuy, Inc.
Dental
117d
Cleared
Aug 12, 1982
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
Depuy, Inc.
Dental
58d
About Product Code LYC - Regulatory Context
510(k) Submission Activity
230 total 510(k) submissions under product code LYC since 1979, with 230 receiving FDA clearance (average review time: 168 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - LYC Product Code
Recent submissions under LYC have taken an average of 251 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 →