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
231 devices
49–72 of 231
Cleared Apr 24, 2007
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
K062834
Genoss Co., Ltd.
Dental · 215d
Cleared Feb 22, 2007
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
K063596
Novabone Products, LLC
Dental · 80d
Cleared Feb 12, 2007
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K063549
Novabone Products, LLC
Dental · 80d
Cleared Feb 14, 2006
PERIOGLAS BONE GRAFT PARTICULATE
K053387
Novabone Products, LLC
Dental · 71d
Cleared Jan 23, 2006
SYNTHES (USA) CHRONOS-BETA-TCP
K053022
Synthes (Usa)
Dental · 89d
Cleared Sep 01, 2005
SYNTHOGRAFT
K051091
Bicon, Inc.
Dental · 126d
Cleared Aug 26, 2005
FORTOSS VITAL BONE GRAFT SUBSTITUTE
K050170
Biocomposites, Ltd.
Dental · 212d
Cleared Aug 11, 2005
BIOPLANT
K050984
Kerr Dental Materials Center
Dental · 114d
Cleared Jul 22, 2005
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO
K051443
Curasan Ag, Frankfurt Facility
Dental · 50d
Cleared Jul 19, 2005
CALC-I-OSS
K042583
Ultradent Products, Inc.
Dental · 300d
Cleared Jul 15, 2005
BIORESORB MACRO PORE
K050260
Oraltronics Dental Implant Technology GmbH
Dental · 162d
Cleared Jul 15, 2005
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
K051381
Ace Surgical Supply Co., Inc.
Dental · 49d
Cleared Feb 14, 2005
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
K042730
Lifecorebiomedical
Dental · 136d
Cleared Dec 06, 2004
OSTIM
K030052
Heraeus Kulzer, Inc.
Dental · 700d
Cleared Oct 20, 2004
OSSATURA DENTAL
K042706
Isotis Orthobiologics, Inc.
Dental · 20d
Cleared Oct 13, 2004
FOUNDATION
K040783
Terumo Corp.
Dental · 201d
Cleared Jul 19, 2004
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
K041324
Lifecore Biomedical, Inc.
Dental · 62d
Cleared Mar 25, 2004
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
K033994
Novabone Products, LLC
Dental · 92d
Cleared Mar 17, 2004
COLLAGEN DENTAL WOUND DRESSINGS
K033729
Collagen Matrix, Inc.
Dental · 110d
Cleared Mar 01, 2004
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
K040278
Novabone Products, LLC
Dental · 25d
Cleared Nov 05, 2003
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
K031073
Novabone Products, LLC
Dental · 215d
Cleared Feb 05, 2003
FRIOS ALGIPORE
K023799
Friadent GmbH
Dental · 83d
Cleared Apr 10, 2002
BIOCELLECT -PERIO
K020396
Imtec Corp.
Dental · 63d
Cleared Mar 28, 2002
ORTHOSS RESORBABLE BONE VOID FILLER
K014289
Geistlich-Pharma
Dental · 90d