FDA 510(k) Applications for Medical Device Product Code "LYC"
(Bone Grafting Material, Synthetic)
| 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 |
| K110198 | BLUE SKY BIO, LLC | BLUE SKY BIO TCP | 12/22/2011 |
| 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 |
| K103709 | CURASAN AG | CERACELL DENTAL | 03/10/2011 |
| 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 |
| K241186 | Shenzhen Dazhou Medical Technology Co., Ltd. | Synthetic Bone Graft Particulate | 02/21/2025 |
| 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 |
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