FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K051381 |
ACE SURGICAL SUPPLY CO., INC. |
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE |
07/15/2005 |
K090850 |
APATECH LTD. |
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE |
07/30/2009 |
K994137 |
ATRIX LABORATORIES, INC. |
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE |
09/13/2000 |
K121177 |
AUGMA BIOMATERIALS, LTD. |
BOND APATITE |
12/05/2013 |
K083858 |
AUGMA BIOMATERIALS, LTD. |
BOND BONE |
03/17/2009 |
K081721 |
BAXTER HEALTHCARE CORP. |
TRICOS A RESORBABLE SUBSTITUTE |
08/06/2008 |
K073571 |
BAXTER HEALTHCARE CORPORATION |
TRICOS T RESORBABLE BONE SUBSTITUTE |
04/08/2008 |
K051091 |
BICON, INC. |
SYNTHOGRAFT |
09/01/2005 |
K954763 |
BIO-INTERFACES, INC. |
BIO-INTERFACES, INC,. BII-PLAST |
01/04/1996 |
K960164 |
BIO-INTERFACES, INC. |
BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140 |
04/10/1996 |
K060285 |
BIO-LOK INTL., INC. |
BONEGEN - TR |
03/16/2006 |
K090793 |
BIOALPHA, INC. |
BONGROS HA |
05/19/2009 |
K960267 |
BIOCOLL LABORATORIES, INC. |
TBM SPONGE |
11/05/1996 |
K082383 |
BIOCOMPOSITES LTD. |
FORTOSS VITAL |
09/05/2008 |
K050170 |
BIOCOMPOSITES LTD. |
FORTOSS VITAL BONE GRAFT SUBSTITUTE |
08/26/2005 |
K993238 |
BIOCOMPOSITES LTD. |
FORTOSS-CEMA |
01/14/2000 |
K030682 |
BIOFORM, INC. |
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 |
06/27/2003 |
K051885 |
BIOMATLANTE |
MBCP |
09/16/2005 |
K060732 |
BIOMATLANTE |
MBCP GEL |
06/02/2006 |
K093122 |
BIOMATLANTE |
MBCP+ |
03/15/2010 |
K110449 |
BIOMET 3I |
ENDOBON XENOGRAFT GRANULES |
05/13/2011 |
K003493 |
BIOMET, INC. |
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT |
02/09/2001 |
K980679 |
BIOMET, INC. |
ENDOBON |
04/03/1998 |
K003494 |
BIOMET, INC. |
MIMIX BONE REPLACEMENT SYSTEM |
04/09/2001 |
K080308 |
BIOSCAFFOLD INTERNATIONAL PTE LTD |
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD |
04/14/2008 |
K000633 |
BLUE SKY BIO |
SYNTHETIC GLASS BONE GRAFT MATERIAL |
05/25/2000 |
K083372 |
BRAINBASE CORPORATION |
ARROWBONE-A, ARROWBONE-B |
12/08/2009 |
K962786 |
CERAMED CORP. |
OSTEOGRAF STAINLESS STEEL SYRING |
08/01/1996 |
K960353 |
CERAMED CORP. |
OSTEOGRAF/LD-300 HYDROXYLAPATITE |
04/18/1996 |
K960348 |
CERAMED CORP. |
OSTEOGRAF/N-300 HYDROXYLAPATITE |
04/22/1996 |
K954631 |
CERAMED CORP. |
OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE |
01/02/1996 |
K960368 |
CERAMED CORP. |
OSTEOGRAFT/N-700 HYDROXYLAPTITE |
04/18/1996 |
K960361 |
CERAMED CORP. |
PERMAMESH-D HYDROXYLAPATITE MATRIX |
04/15/1996 |
K962838 |
CERAMED CORP. |
PERMARIDGE SYRINGE |
08/20/1996 |
K981182 |
CERAMED DENTAL, LLC. |
OSTEOGRAF/N-300 |
07/02/1998 |
K981214 |
CERAMED DENTAL, LLC. |
OSTEOGRAF/N-700 |
06/26/1998 |
K103820 |
CERAMISYS LTD |
REPROBONE DENTAL GRAFTING MATERIAL |
11/03/2011 |
K001598 |
COL-BAR LTD. |
BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION |
08/22/2000 |
K033729 |
COLLAGEN MATRIX, INC. |
COLLAGEN DENTAL WOUND DRESSINGS |
03/17/2004 |
K083742 |
COLLAGEN MATRIX, INC. |
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX |
02/12/2009 |
K072397 |
COLLAGEN MATRIX, INC. |
SYNOSS SYNTHETIC BONE GRAFT MATERIAL |
10/18/2007 |
K111105 |
CURASAN AG |
CURASAN OSSEOLIVE DENTAL |
12/20/2012 |
K102872 |
CURASAN AG |
OSBONE DENTAL |
01/12/2011 |
K051443 |
CURASAN AG, FRANKFURT FACILITY |
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO |
07/22/2005 |
K093871 |
CYTOPHIL INC |
PERIOPHIL B-TCP |
04/22/2010 |
K092788 |
CYTOPHIL INC |
PERIOPHIL BIPHASIC |
12/18/2009 |
K131385 |
Degradable Solutions AG |
EASY-GRAFT |
09/27/2013 |
K072052 |
DENTSPLY INTERNATIONAL, INC. |
OSTEOGRAF/D-300 |
08/08/2007 |
K072056 |
DENTSPLY INTERNATIONAL, INC. |
OSTEOGRAF/D-700 |
08/06/2007 |
K072057 |
DENTSPLY INTERNATIONAL, INC. |
OSTEOGRAF/LD-300 |
08/06/2007 |
K072058 |
DENTSPLY INTERNTIONAL |
MODIFICATION TO: OSTEOGRAF/N-700 |
08/03/2007 |
K071817 |
DENTSPLY INTERNTIONAL |
OSTEOGRAF/N-300 |
09/04/2007 |
K010320 |
DEPUY ACROMED |
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM |
03/01/2001 |
K003286 |
DEPUY ACROMED |
SYMPHONY GRAFT DELIVERY SYSTEM |
01/18/2001 |
K093390 |
DEPUY SPINE, INC. |
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 |
05/25/2010 |
K081432 |
DEPUY SPINE, INC. |
HEALOS II BONE GRAFT SUBSTITUTE |
08/29/2008 |
K213260 |
Dimension Inx Corp. |
CMFlexTM |
12/30/2022 |
K091729 |
ETEX CORP. |
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE |
12/23/2009 |
K962548 |
ETEX CORP. |
BSM BONE SUBSTITUTE MATERIAL KIT |
08/05/1997 |
K100883 |
ETEX CORP. |
CARRIGEN |
12/21/2010 |
K102812 |
ETEX CORPORATION |
GAMMA-BSM; BETA-BSM; EQUIVABONE |
12/03/2010 |
K023799 |
FRIADENT GMBH |
FRIOS ALGIPORE |
02/05/2003 |
K192597 |
GC America, Inc. |
Cytrans Granules |
08/17/2020 |
K970569 |
GEISTLICH-PHARMA |
BIO-BLOCKS |
08/14/2000 |
K970321 |
GEISTLICH-PHARMA |
BIO-OSS ANORGANIC BOVINE BONE |
09/15/1998 |
K974399 |
GEISTLICH-PHARMA |
BIO-OSS COLLAGEN |
09/16/1998 |
K014289 |
GEISTLICH-PHARMA |
ORTHOSS RESORBABLE BONE VOID FILLER |
03/28/2002 |
K972817 |
GEISTLICH-PHARMA |
RESOR-PIN RESORBABLE MEMBRANE PIN |
07/24/1998 |
K112716 |
GENOSS CO., LTD. |
OSTEON II |
01/17/2012 |
K153676 |
GENOSS CO., LTD. |
OSTEON III |
09/14/2016 |
K062834 |
GENOSS CO., LTD. |
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 |
04/24/2007 |
K102015 |
GENOSS CO., LTD. |
OSTEON, OSTEON SINUS, OSTEON LIFTING |
11/19/2010 |
K082286 |
GRAFTYS |
BIOACTYS |
02/24/2009 |
K011032 |
HARVEST TECHNOLOGIES, CORP. |
SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA |
07/03/2001 |
K030052 |
HERAEUS KULZER, INC. |
OSTIM |
12/06/2004 |
K033098 |
IMPLADENT, LTD. |
OSTEOGEN SBRG |
04/27/2004 |
K012047 |
IMPLANT INNOVATIONS, INC. |
3I CALCIUM SULFATE BONE CEMENT |
09/19/2001 |
K010775 |
IMTEC CORP. |
BIOCELLECT |
06/12/2001 |
K020396 |
IMTEC CORP. |
BIOCELLECT -PERIO |
04/10/2002 |
K950306 |
IMTEC CORP. |
IMTEC BIOBARRIER |
02/06/1996 |
K070784 |
INION OY |
INION BIORESTORE |
07/24/2007 |
K201051 |
Institut Straumann AG |
Straumann BoneCeramic |
09/24/2020 |
K992216 |
INTEGRA LIFESCIENCES CORP. |
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE |
07/26/1999 |
K972842 |
INTERPORE INTL. |
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE |
10/30/1997 |
K031813 |
ISOTIS NV |
OSSATURA DENTAL |
08/20/2004 |
K042706 |
ISOTIS ORTHOBIOLOGICS, INC |
OSSATURA DENTAL |
10/20/2004 |
K050984 |
KERR DENTAL MATERIALS CENTER |
BIOPLANT |
08/11/2005 |
K092194 |
KYUNGWON MEDICAL CO., LTD. |
POLYBONE DENTAL |
06/16/2010 |
K042730 |
LIFECORE BIOMEDICAL |
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G |
02/14/2005 |
K041324 |
LIFECORE BIOMEDICAL, INC. |
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER |
07/19/2004 |
K955096 |
LIFECORE BIOMEDICAL, INC. |
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER |
01/23/1996 |
K990537 |
LUITPOLD PHARMACEUTICALS, INC. |
OSTEO-PIN MEMBRANE FIXATION PIN |
11/19/1999 |
K101014 |
M.I.S. IMPLANTS TECHNOLOGIES LTD. |
BOND BONE |
10/21/2010 |
K101426 |
MATHYS LTD |
CEROS TCP GRANULES |
09/15/2010 |
K081784 |
MEDTRONIC SOFAMOR DANEK |
MASTERGRAFT PUTTY |
09/17/2008 |
K082917 |
MEDTRONIC SOFAMOR DANEK |
MASTERGRAFT RESORBABLE CERAMIC GRANULES |
01/09/2009 |
K140374 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MASTERGRAFT PUTTY |
06/10/2014 |
K092087 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MEDTRONIC DENTAL TCP |
12/30/2009 |
K010701 |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER |
06/05/2001 |
K090950 |
MEGAGEN IMPLANT CO., LTD |
BONE PLUS BCP |
07/02/2010 |
K122240 |
MEGAGEN IMPLANT CO., LTD |
BONE PLUS BCP EAGLE EYE |
08/21/2012 |
K080772 |
META BIOMED CO., LTD. |
BONEMEDIK-DM |
06/03/2008 |
K983104 |
NORIAN CORP. |
NORIAN PERIODONTAL/DENTAL CEMENT (PDC) |
02/12/1999 |
K112428 |
NovaBone Products, LLC |
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT |
12/16/2011 |
K091484 |
NovaBone Products, LLC |
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT |
06/15/2009 |
K100671 |
NovaBone Products, LLC |
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
03/30/2010 |
K063549 |
NovaBone Products, LLC |
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
02/12/2007 |
K033994 |
NovaBone Products, LLC |
NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE |
03/25/2004 |
K053387 |
NovaBone Products, LLC |
PERIOGLAS BONE GRAFT PARTICULATE |
02/14/2006 |
K031073 |
NovaBone Products, LLC |
PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE |
11/05/2003 |
K063596 |
NovaBone Products, LLC |
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL |
02/22/2007 |
K040278 |
NovaBone Products, LLC |
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE |
03/01/2004 |
K030195 |
OCT, USA, INC. |
BBP BONE SUBSTITUTES |
06/17/2004 |
K111087 |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
FOUNDATION |
11/29/2011 |
K081561 |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
OSFERION D |
07/28/2008 |
K050260 |
ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH |
BIORESORB MACRO PORE |
07/15/2005 |
K011403 |
ORTHOGEN CORP. |
SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE |
09/11/2001 |
K102208 |
ORTHOGEN, LLC |
NANOGEN |
05/06/2011 |
K091618 |
ORTHOVITA, INC. |
VITOMATRIX |
09/27/2010 |
K053374 |
OSSACUR AG |
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM) |
02/21/2006 |
K202675 |
Osteogene Tech Corp |
InRoad« Dental Synthetic Bone Graft |
03/04/2022 |
K993610 |
OSTEOGENICS BIOMEDICAL, INC. |
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 |
03/02/2000 |
K964342 |
OSTEOGENICS CO. |
CYTOPLAST GBR |
03/11/1997 |
K972278 |
OSTEOGENICS CO. |
CYTOPLAST REGENTEX TITANIUM 250 |
08/06/1997 |
K201546 |
RevisiOs BV |
OsOpia Synthetic Bone Void Filler |
10/02/2020 |
K113282 |
RIEMSER ARZEIMITTEL AG |
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO |
09/20/2012 |
K063634 |
SEPTODONT |
RTR SYRINGE |
05/11/2007 |
K063010 |
STEINER LABORATORIES |
REGEN BIOCEMENT |
11/28/2006 |
K052493 |
STEINER LABORATORIES |
SOCKET GRAFT |
06/09/2006 |
K113049 |
STEINER LABORATORIES |
SOCKET GRAFT |
01/27/2012 |
K101718 |
STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC |
OSSEOCONDUCT |
10/26/2010 |
K053022 |
SYNTHES (USA) |
SYNTHES (USA) CHRONOS-BETA-TCP |
01/23/2006 |
K083005 |
TEKNIMED SA |
NANGEL |
03/04/2009 |
K062102 |
TEKNIMED SA |
ODONCER |
04/16/2007 |
K040783 |
TERUMO CORP. |
FOUNDATION |
10/13/2004 |
K101827 |
TEXAS INNOVATIVE MEDICAL DEVICES (DBA) SKELETAL |
OSTEOSCAF |
04/20/2011 |
K033110 |
THE CLINICIAN'S PREFERENCE LLC |
C-GRAFT |
12/10/2003 |
K153230 |
THE IMPLANTECH INC./SHEFABONE |
ShefaBone SCPC Resorbable Bone Graft |
07/14/2016 |
K040646 |
THE STRAUMANN CO. |
STRAUMANN GRANULES |
05/03/2004 |
K023998 |
THERICS, INC. |
THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE |
03/26/2003 |
K940643 |
THM BIOMEDICAL, INC. |
OSMED EPI-GUIDE |
10/15/1996 |
K000149 |
U.S. BIOMATERIALS CORP. |
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE |
02/07/2000 |
K962494 |
U.S. BIOMATERIALS CORP. |
PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE |
09/20/1996 |
K992416 |
U.S. BIOMATERIALS CORP. |
PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE |
10/15/1999 |
K042583 |
ULTRADENT PRODUCTS, INC. |
CALC-I-OSS |
07/19/2005 |
K982699 |
UNICARE BIOMEDICAL |
UNIGRAFE |
10/20/1998 |
K003457 |
UNICARE BIOMEDICAL |
UNIGRAFT |
01/09/2001 |
K993784 |
UNICARE BIOMEDICAL |
UNIGRAFT |
01/27/2000 |
K012144 |
UNICARE BIOMEDICAL, INC. |
CYTOFLEX |
10/01/2001 |
K090083 |
UNICARE BIOMEDICAL, INC. |
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 |
03/23/2009 |
K092567 |
UNICARE BIOMEDICAL, INC. |
MODIFICATION TO UNIGRAFT |
11/25/2009 |
K020720 |
UNICARE BIOMEDICAL, INC. |
OSSIFORM |
05/07/2002 |
K070055 |
VIVOXID LTD. |
BONALIVE GRANULES AND BONALIVE PLATES |
06/25/2007 |
K013346 |
W.L. GORE & ASSOCIATES,INC |
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE |
12/19/2001 |
K973594 |
W.L. GORE & ASSOCIATES,INC |
GORE RESOLUT XT REGENERATIVE MATERIAL |
12/17/1997 |
K962624 |
W.L. GORE & ASSOCIATES,INC |
RESOLUT REGENERATIVE MATERIAL |
10/03/1996 |
K970884 |
W.L. GORE & ASSOCIATES,INC |
RESOLUT REGENERATIVE MATERIAL |
05/08/1997 |