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Panels › Dental › Product code LYC · Class 2

Bone Grafting Material, Synthetic

Regulation 872.3930

3510(k)s in 12 months (231 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
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Top companies in LYC

Company510(k)sRecalls
Bio-Interfaces, Inc.150
Ceramed Corp.130
Geistlich-Pharma110
Novabone Products, LLC90
Unicare Biomedical70
Coors Biomedical Co.60
Interpore Intl.60
Lifecore Biomedical, Inc.41
Medtronic Sofamor Danek50
W. L. Gore & Associates, Inc.50
DateFirm and productCodeLinked 510(k)
Nov 9, 2018Collagen Matrix, Inc.
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Terminated		 LYCK062846
Sep 7, 2016Osteogenics Biomedical, Inc.
Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
Terminated		 LYCK972278
Feb 9, 2016Biomet France SARL
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the fo
Terminated		 LYCK110449
Mar 19, 2014Biomet 3i, LLC
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma
Terminated		 LYCK980679
May 10, 2013Integra LifeSciences Corporation
BioMend Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to
Terminated		 LYCK924408
May 10, 2013Integra LifeSciences Corporation
BioMend Extend" Absorbable Collagen Membrane BioMend Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodo
Terminated		 LYCK992216
May 10, 2013Integra LifeSciences Corporation
OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to en
Terminated		 LYCK924408
Nov 20, 2012Kerr Corporation
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a
Terminated		 LYCNone listed
Feb 13, 2012Cytophil, Inc
Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc
Terminated		 LYCK092788
Jun 16, 2010Ace Surgical Supply Co., Inc.
Calcium Sulfate Hemihydrate 1.0 gram kits.
Terminated		 LYCK051381
Jun 16, 2010Ace Surgical Supply Co., Inc.
Calcium Sulfate Hemihydrate 0.5 gram kits.
Terminated		 LYCK051381
Feb 6, 2009Zimmer Inc.
Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003. Device is used fo
Terminated		 LYCK811101
Feb 4, 2006QLT USA, Inc.
Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
Terminated		 LYCK982865
Jul 20, 2004Lifecore Biomedical, Inc.
TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.
Terminated		 LYCK935137

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