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 Bio-Interfaces, Inc., Novabone Products, LLC and Ceramed Corp..

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

1 2 3 4

Bonalive Maxillofacial

Full Golden Biotech Co., Ltd.

Full Golden Biotech Corporation

Dental · 267d

Cleared Feb 21, 2025

Synthetic Bone Graft Particulate

K241186

Shenzhen Dazhou Medical Technology Co., Ltd.

InRoad® Dental Synthetic Bone Graft

OsOpia Synthetic Bone Void Filler

Straumann BoneCeramic

K201051

Institut Straumann AG

ShefaBone SCPC Resorbable Bone Graft

K153230

The Implantech Inc./Shefabone

Medtronic Sofamor Danek USA, Inc.

Augma Biomaterials, Ltd.

Degradable Solutions AG

Dental · 136d

Cleared Dec 20, 2012

CURASAN OSSEOLIVE DENTAL

CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO

K113282

Riemser Arzeimittel AG

Dental · 318d

Cleared Aug 21, 2012

BONE PLUS BCP EAGLE EYE

K122240

Megagen Implant Co., Ltd.

NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT

K112428

Novabone Products, LLC

Olympus Terumo Biomaterials Corporation

Dental · 224d

1 2 3 4

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 →

FDA Product Code LYC: Bone Grafting Material, Synthetic

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

About Product Code LYC - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - LYC Product Code

Related FDA 510(k) Regulatory Insights