LYC · Class II · 21 CFR 872.3930

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 W.L. Gore & Associates, Inc., Biomet, Inc. and Medtronic Sofamor Danek USA, Inc..

231
Total
231
Cleared
169d
Avg days
1979
Since
Growing category - 6 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 256d recently vs 166d historically

FDA 510(k) Cleared Bone Grafting Material, Synthetic Devices (Product Code LYC)

231 devices
1–24 of 231
Cleared Jul 06, 2026
Cytrans™ Elashield
K253317
GC America, Inc.
Dental · 279d
Cleared May 14, 2026
Bonalive Maxillofacial
K253883
Bonalive , Ltd.
Dental · 161d
Cleared Mar 06, 2026
BONTREE PLUS
K251818
Hudens Bio Co., Ltd.
Dental · 266d
Cleared Sep 17, 2025
FG Bone Graft M
K244006
Full Golden Biotech Co., Ltd.
Dental · 265d
Cleared Aug 29, 2025
FG Bone Graft B
K243745
Full Golden Biotech Corporation
Dental · 267d
Cleared Feb 21, 2025
Synthetic Bone Graft Particulate
K241186
Shenzhen Dazhou Medical Technology Co., Ltd.
Dental · 298d
Cleared Dec 30, 2022
CMFlexTM
K213260
Dimension Inx Corp.
Dental · 456d
Cleared Mar 04, 2022
InRoad® Dental Synthetic Bone Graft
K202675
Osteogene Tech Corp
Dental · 535d
Cleared Oct 02, 2020
OsOpia Synthetic Bone Void Filler
K201546
Revisios BV
Dental · 115d
Cleared Sep 24, 2020
Straumann BoneCeramic
K201051
Institut Straumann AG
Dental · 156d
Cleared Aug 17, 2020
Cytrans Granules
K192597
GC America, Inc.
Dental · 332d
Cleared Jun 10, 2014
MASTERGRAFT PUTTY
K140374
Medtronic Sofamor Danek USA, Inc.
Dental · 116d
Cleared May 25, 2010
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
K093390
Depuy Spine, Inc.
Dental · 208d
Cleared Dec 30, 2009
MEDTRONIC DENTAL TCP
K092087
Medtronic Sofamor Danek USA, Inc.
Dental · 174d
Cleared Feb 12, 2009
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K083742
Collagen Matrix, Inc.
Dental · 58d
Cleared Jan 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917
Medtronic Sofamor Danek
Dental · 101d
Cleared Sep 17, 2008
MASTERGRAFT PUTTY
K081784
Medtronic Sofamor Danek
Dental · 85d
Cleared Aug 29, 2008
HEALOS II BONE GRAFT SUBSTITUTE
K081432
Depuy Spine, Inc.
Dental · 100d
Cleared Aug 06, 2008
TRICOS A RESORBABLE SUBSTITUTE
K081721
Baxter Healthcare Corp
Dental · 49d
Cleared Apr 08, 2008
TRICOS T RESORBABLE BONE SUBSTITUTE
K073571
Baxter Healthcare Corporation
Dental · 110d
Cleared Oct 18, 2007
SYNOSS SYNTHETIC BONE GRAFT MATERIAL
K072397
Collagen Matrix, Inc.
Dental · 52d
Cleared Aug 08, 2007
OSTEOGRAF/D-300
K072052
Dentsply International, Inc.
Dental · 13d
Cleared Aug 06, 2007
OSTEOGRAF/D-700
K072056
Dentsply International, Inc.
Dental · 11d
Cleared Aug 06, 2007
OSTEOGRAF/LD-300
K072057
Dentsply International, Inc.
Dental · 11d

About Product Code LYC - Regulatory Context

510(k) Submission Activity

231 total 510(k) submissions under product code LYC since 1979, with 231 receiving FDA clearance (average review time: 169 days).

Submission volume has increased in recent years - 6 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 256 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 →