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., Ceramed Corp. and Novabone Products, LLC.

231
Total
231
Cleared
169d
Avg days
1979
Since
231 devices
121–144 of 231
Cleared Aug 07, 1995
BIO-OSS
K952617
Geistlich-Pharma
Dental · 62d
Cleared May 09, 1995
BIO-APATITE 6140 HA PARTICLES
K950567
Bio-Interfaces, Inc.
Dental · 90d
Cleared Apr 27, 1995
BLL-FIL 6140 PARTICLES
K950511
Bio-Interfaces, Inc.
Dental · 80d
Cleared Apr 10, 1995
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K943186
Lifecore Biomedical, Inc.
Dental · 279d
Cleared Mar 28, 1995
RESOLUT REGENERATIVE MATERIAL
K932866
W.L. Gore & Associates, Inc.
Dental · 652d
Cleared Mar 28, 1995
INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS
K950165
Interpore Intl.
Dental · 70d
Cleared Oct 05, 1994
OSTEOGRAF/D-100 HYDROXYLAPATITE
K942946
Ceramed Corp.
Dental · 104d
Cleared Aug 23, 1994
OSTEOGRAF/LD-300 HYDROXYLAPATITE
K942212
Ceramed Corp.
Dental · 109d
Cleared Jul 19, 1994
BII-PORE
K933688
Bio-Interfaces, Inc.
Dental · 355d
Cleared Jul 19, 1994
BII-PORE(TM) CANAL WALL PROSTHESIS
K934049
Bio-Interfaces, Inc.
Dental · 334d
Cleared May 18, 1994
BON APATITE HA PARTICLES
K934430
Bio-Interfaces, Inc.
Dental · 247d
Cleared Jan 26, 1994
BII-PLAST
K934947
Bio-Interfaces, Inc.
Dental · 100d
Cleared Apr 30, 1993
710 POROUS HA PARTICLES-BII-PORE
K924287
Bio-Interfaces, Inc.
Dental · 248d
Cleared Apr 14, 1993
BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE
K922487
Bio-Interfaces, Inc.
Dental · 322d
Cleared Apr 14, 1993
4060 POROUS HA PARTICULES BII PORE
K924286
Bio-Interfaces, Inc.
Dental · 232d
Cleared Apr 14, 1993
B1018 POROUS HA BII-PORE
K924288
Bio-Interfaces, Inc.
Dental · 232d
Cleared Dec 04, 1992
1840 HA PARTICLES
K921776
Bio-Interfaces, Inc.
Dental · 235d
Cleared May 01, 1991
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K910432
Lifecore Biomedical, Inc.
Dental · 90d
Cleared Jan 11, 1989
4060 HA PARTICLES
K885067
Bio-Interfaces, Inc.
Dental · 36d
Cleared Dec 29, 1986
HYDROXYLAPATITE BONE GRAFT MATERIAL
K863237
Richards Medical Co., Inc.
Dental · 130d
Cleared May 23, 1986
INTERPORE 200 POROUS HYDROXYAPATITE
K860983
Interpore Intl.
Dental · 67d
Cleared Oct 07, 1985
OSTEOGRAF 2040 OSTEOGRAF 4060
K852199
Osteotech, Inc.
Dental · 140d
Cleared Sep 23, 1985
CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
K852682
Calcitek, Inc.
Dental · 90d
Cleared Nov 07, 1984
HYDROXYAPATITE
K842718
Depuy, Inc.
Dental · 117d