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
97–120 of 231
Cleared Dec 17, 1997
GORE RESOLUT XT REGENERATIVE MATERIAL
K973594
W.L. Gore & Associates, Inc.
Dental · 86d
Cleared Oct 30, 1997
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
K972842
Interpore Intl.
Dental · 90d
Cleared Aug 06, 1997
CYTOPLAST REGENTEX TITANIUM 250
K972278
Osteogenics Co.
Dental · 49d
Cleared Aug 05, 1997
BSM BONE SUBSTITUTE MATERIAL KIT
K962548
Etex Corp.
Dental · 403d
Cleared May 08, 1997
RESOLUT REGENERATIVE MATERIAL
K970884
W.L. Gore & Associates, Inc.
Dental · 59d
Cleared Mar 11, 1997
CYTOPLAST GBR
K964342
Osteogenics Co.
Dental · 131d
Cleared Nov 05, 1996
TBM SPONGE
K960267
Biocoll Laboratories, Inc.
Dental · 292d
Cleared Oct 15, 1996
OSMED EPI-GUIDE
K940643
Thm Biomedical, Inc.
Dental · 974d
Cleared Oct 03, 1996
RESOLUT REGENERATIVE MATERIAL
K962624
W.L. Gore & Associates, Inc.
Dental · 90d
Cleared Sep 20, 1996
PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE
K962494
Usbiomaterials Corp.
Dental · 86d
Cleared Aug 20, 1996
PERMARIDGE SYRINGE
K962838
Ceramed Corp.
Dental · 29d
Cleared Aug 01, 1996
OSTEOGRAF STAINLESS STEEL SYRING
K962786
Ceramed Corp.
Dental · 15d
Cleared Apr 22, 1996
OSTEOGRAF/N-300 HYDROXYLAPATITE
K960348
Ceramed Corp.
Dental · 88d
Cleared Apr 18, 1996
OSTEOGRAF/LD-300 HYDROXYLAPATITE
K960353
Ceramed Corp.
Dental · 84d
Cleared Apr 18, 1996
OSTEOGRAFT/N-700 HYDROXYLAPTITE
K960368
Ceramed Corp.
Dental · 84d
Cleared Apr 15, 1996
PERMAMESH-D HYDROXYLAPATITE MATRIX
K960361
Ceramed Corp.
Dental · 81d
Cleared Apr 10, 1996
BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140
K960164
Bio-Interfaces, Inc.
Dental · 85d
Cleared Feb 06, 1996
IMTEC BIOBARRIER
K950306
Imtec Corp.
Dental · 377d
Cleared Jan 23, 1996
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K955096
Lifecore Biomedical, Inc.
Dental · 77d
Cleared Jan 04, 1996
BIO-INTERFACES, INC,. BII-PLAST
K954763
Bio-Interfaces, Inc.
Dental · 79d
Cleared Jan 02, 1996
OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE
K954631
Ceramed Corp.
Dental · 88d
Cleared Aug 28, 1995
BIO-OSS
K952618
Geistlich-Pharma
Dental · 83d
Cleared Aug 28, 1995
BIO-OSS CERAMIC
K952619
Geistlich-Pharma
Dental · 83d
Cleared Aug 23, 1995
BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT
K950598
Bio-Interfaces, Inc.
Dental · 195d