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., Ceramed Corp. and Novabone Products, LLC.

231
Total
231
Cleared
169d
Avg days
1979
Since
231 devices
25–48 of 231
Cleared Nov 03, 2011
REPROBONE DENTAL GRAFTING MATERIAL
K103820
Ceramisys, Ltd.
Dental · 308d
Cleared May 13, 2011
ENDOBON XENOGRAFT GRANULES
K110449
Biomet 3i
Dental · 86d
Cleared Mar 10, 2011
CERACELL DENTAL
K103709
Curasan AG
Dental · 80d
Cleared Dec 21, 2010
CARRIGEN
K100883
Etex Corp.
Dental · 266d
Cleared Nov 19, 2010
OSTEON, OSTEON SINUS, OSTEON LIFTING
K102015
Genoss Co., Ltd.
Dental · 126d
Cleared Sep 27, 2010
VITOMATRIX
K091618
Orthovita, Inc.
Dental · 481d
Cleared Jul 02, 2010
BONE PLUS BCP
K090950
Megagen Implant Co., Ltd.
Dental · 455d
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 Mar 30, 2010
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K100671
Novabone Products, LLC
Dental · 21d
Cleared Dec 30, 2009
MEDTRONIC DENTAL TCP
K092087
Medtronic Sofamor Danek USA, Inc.
Dental · 174d
Cleared Dec 23, 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091729
Etex Corp.
Dental · 195d
Cleared Jun 15, 2009
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K091484
Novabone Products, LLC
Dental · 27d
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 Sep 05, 2008
FORTOSS VITAL
K082383
Biocomposites, Ltd.
Dental · 17d
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 Jun 03, 2008
BONEMEDIK-DM
K080772
Meta Biomed Co., Ltd.
Dental · 76d
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