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
73–96 of 231
Cleared Dec 19, 2001
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K013346
W.L. Gore & Associates, Inc.
Dental · 71d
Cleared Sep 19, 2001
3I CALCIUM SULFATE BONE CEMENT
K012047
Implant Innovations, Inc.
Dental · 82d
Cleared Jun 12, 2001
BIOCELLECT
K010775
Imtec Corp.
Dental · 90d
Cleared Jun 05, 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701
Medtronic Sofamor Danek USA, Inc.
Dental · 89d
Cleared Apr 09, 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494
Biomet, Inc.
Dental · 147d
Cleared Mar 01, 2001
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K010320
Depuyacromed
Dental · 27d
Cleared Feb 09, 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K003493
Biomet, Inc.
Dental · 88d
Cleared Jan 18, 2001
SYMPHONY GRAFT DELIVERY SYSTEM
K003286
Depuyacromed
Dental · 90d
Cleared Sep 13, 2000
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE
K994137
Atrix Laboratories, Inc.
Dental · 281d
Cleared Aug 14, 2000
BIO-BLOCKS
K970569
Geistlich-Pharma
Dental · 1294d
Cleared Mar 02, 2000
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
K993610
Osteogenics Biomedical, Inc.
Dental · 129d
Cleared Jan 27, 2000
UNIGRAFT
K993784
Unicare Biomedical
Dental · 80d
Cleared Jan 14, 2000
FORTOSS-CEMA
K993238
Biocomposites, Ltd.
Dental · 109d
Cleared Nov 19, 1999
OSTEO-PIN MEMBRANE FIXATION PIN
K990537
Luitpold Pharmaceuticals, Inc.
Dental · 273d
Cleared Oct 15, 1999
PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE
K992416
Usbiomaterials Corp.
Dental · 87d
Cleared Jul 26, 1999
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
K992216
Integra Lifesciences Corp.
Dental · 25d
Cleared Feb 12, 1999
NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
K983104
Norian Corp.
Dental · 161d
Cleared Oct 20, 1998
UNIGRAFE
K982699
Unicare Biomedical
Dental · 78d
Cleared Sep 16, 1998
BIO-OSS COLLAGEN
K974399
Geistlich-Pharma
Dental · 299d
Cleared Sep 15, 1998
BIO-OSS ANORGANIC BOVINE BONE
K970321
Geistlich-Pharma
Dental · 595d
Cleared Jul 24, 1998
RESOR-PIN RESORBABLE MEMBRANE PIN
K972817
Geistlich-Pharma
Dental · 360d
Cleared Jul 02, 1998
OSTEOGRAF/N-300
K981182
Ceramed Dental, LLC
Dental · 92d
Cleared Jun 26, 1998
OSTEOGRAF/N-700
K981214
Ceramed Dental, LLC
Dental · 85d
Cleared Apr 03, 1998
ENDOBON
K980679
Biomet, Inc.
Dental · 42d