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 W.L. Gore & Associates, Inc., Biomet, Inc. and Medtronic Sofamor Danek USA, Inc..

231
Total
231
Cleared
169d
Avg days
1979
Since
231 devices
25–48 of 231
Cleared Jan 23, 2006
SYNTHES (USA) CHRONOS-BETA-TCP
K053022
Synthes (Usa)
Dental · 89d
Cleared Jul 19, 2005
CALC-I-OSS
K042583
Ultradent Products, Inc.
Dental · 300d
Cleared Dec 06, 2004
OSTIM
K030052
Heraeus Kulzer, Inc.
Dental · 700d
Cleared Mar 17, 2004
COLLAGEN DENTAL WOUND DRESSINGS
K033729
Collagen Matrix, Inc.
Dental · 110d
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 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 Apr 03, 1998
ENDOBON
K980679
Biomet, Inc.
Dental · 42d
Cleared Dec 17, 1997
GORE RESOLUT XT REGENERATIVE MATERIAL
K973594
W.L. Gore & Associates, Inc.
Dental · 86d
Cleared May 08, 1997
RESOLUT REGENERATIVE MATERIAL
K970884
W.L. Gore & Associates, Inc.
Dental · 59d
Cleared Oct 03, 1996
RESOLUT REGENERATIVE MATERIAL
K962624
W.L. Gore & Associates, Inc.
Dental · 90d
Cleared Mar 28, 1995
RESOLUT REGENERATIVE MATERIAL
K932866
W.L. Gore & Associates, Inc.
Dental · 652d
Cleared Dec 29, 1986
HYDROXYLAPATITE BONE GRAFT MATERIAL
K863237
Richards Medical Co., Inc.
Dental · 130d
Cleared Nov 07, 1984
HYDROXYAPATITE
K842718
Depuy, Inc.
Dental · 117d
Cleared Aug 12, 1982
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752
Depuy, Inc.
Dental · 58d