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Prosthetic devices · 21 CFR 872 Subpart D

Synthetic Bone Grafting Material

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.

FDA codeLYCClass221 CFR872.3930Pathway510(k)ImplantCategoryBone grafts & membranes
Companies listing it
6344 makers
Brands and models
273
510(k) clearances
2318 in five years
FDA name
Bone Grafting Material, Synthetic
1979: 11981: 31982: 21983: 21984: 71985: 61986: 81987: 21988: 21989: 21990: 11991: 21992: 41993: 51994: 61995: 131996: 151997: 61998: 71999: 42000: 82001: 122002: 32003: 52004: 112005: 92006: 72007: 132008: 82009: 142010: 132011: 92012: 52013: 22014: 12016: 22020: 32022: 22025: 32026: 319801990200020102020

510(k) clearances per year, 1976–2026

Companies that list LYC

63 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerStraumann BoneCeramic2122026
Dentsply Sirona, Inc.United StatesMakerBondBone · 4BONE BCH1482026
GC America Inc.United StatesMakerCytrans Elashield · Cytrans Granules · Foundation1372026
GENOSS Co., Ltd.South KoreaMakerDT7B0320 · DT7B0420 · DT7B0440 · DT7B0510 · +118232025
Meta Biomed Co, LtdUnited StatesMakerBoneMedik-DM · Renew-Cera242024
Keystone Dental Inc.United StatesMakerCalforma Calcium Sulfate Bone Graft · Calmatrix Calcium Sulfate Bone Graf72024
Collagen Matrix, Inc.United StatesMakerGuidor easy-graft CLASSIC · Guidor easy-graft CLASSIC+ · Guidor easy-graft CRYSTAL · Guidor easy-graft CRYSTAL+ · +3202024
Beijing Naton Technology Group Co. Ltd.ChinaMakerInion BioRestore Synthetic Bone Graft Substitute102025
Bonalive LtdFinlandMakerBonalive Maxillofacial12026
Hudens Bio Co., Ltd.South KoreaMakerBONTREE PLUS12026
Osteogene Tech Inc.United StatesMakerInRoad Synthetic Bone Graft12022
Bicon, LLCUnited StatesMakerSynthoGraft182015
SeptodontFranceMaker—172021
Zimmer IncUnited StatesMakerENDOBON XENOGRAFT GRANULES142001
Medtronic, Inc.United StatesMakerMastergraft Mini Granules · MASTERGRAFT PUTTY112014
Impladent , Ltd.United StatesMakerOsteoGen102014
Novabone Products, LLCUnited StatesMakerBioactive Synthetic Bone Graft Dental Morsels · Bioactive Synthetic Bone Graft Dental Putty Cartridges · Cartridge Dispenser · NovaBone Cartridge Applicator Gun · +392011
Unicare Biomedical, Inc.United StatesMakerCytoflex Resorb · Cytoflex Tefguard · Unigraft92015
SYNTHES (USA) Products LLCUnited StatesMakerbone grafting material · chronOS - ß-TCP - LPK72020
SYNTHES GMBH / Synthes Produktions GmbHUnited StatesMakerbone grafting material52013
Osteogenics Biomedical, Inc.United StatesMakerCytoplast GBR/TXT d-PTFE Membranes · Cytoplast Titanium-Reinforced PTFE Membranes52021
curasan AGGermanyMakerCeracell Dental · CERASORB Bioactive · Cerasorb Dental · IngeniOs Beta-TCP Bioactive · +352012
Baxter Healthcare CorpUnited StatesMakerActifuse42009
Integra LifeSciences CorporationUnited StatesMakerBioMend Absorbable Collagen Membrane · Biomend Extend Absorbable Collagen Membrane · HeliMend Absorbable Collagen Membrane · HeliMend Advanced Absorbable Collagen Membrane · +222014
DePuy Spine, Inc.United StatesMakerHEALOS Dental · HEALOS Dental Bone Graft Replacement · Healos II Bone Graft Substitute · Symphony · +122010
Augma BiomaterialsIsraelMakerBond Apatite · 3D Bond · 3D Bond+22013
Cytophil, IncUnited StatesMaker—22010
TeknimedFranceMaker—22009
Dsm BiomedicalUnited StatesMakerEpi-Guide Bioresorb Barrier Matrix12020
Ceramisys LtdUnited KingdomMakerReproBone¿ Synthetic · Resorbable Bone Graft Substitute12011
BBF Sterilisationsservice GmbHGermanyMakerCeracell DENTAL · IngeniOs ß-TCP Bioactive · Osseolive DENTAL——
DePuy Synthes, Inc.United StatesMakerSymphony——
Advanced Medical Solutions Group PLCUnited KingdomMakerECLIPSE · ECLIPSE Putty · In'Oss · MBCP · +6——
UFP Technologies, Inc.United StatesMakerSYNTHOGRAFT——
Steiner Biotechnology LLCUnited StatesMakerOsseoConduct · Sinus Graft · Socket Graft——
CG Bio Co., Ltd.South KoreaMakerBongros——
GFS Chemicals, Inc.United StatesMakerBeta Tricalcium Phosphate——
Globus Medical IncUnited StatesMakerHarvest SmartJet——
Medos International SARLUnited StatesMakerSYMPHONY - GDS——
VB Spine, LLCUnited StatesMakerVITOMATRIX BONE GRAFTING MATERIAL——
韩国速压科技有限公司SOYAGREENTEC Co.,Ltd.South KoreaMakerOSTEON——
Arctic Biomaterials OyFinlandMaker———
Cam BioceramicsNetherlandsMaker———
Highridge Medical, LLCUnited StatesMaker———
Prismatik Dentalcraft, Inc.United StatesContract manufacturer—562026
Nobel Biocare Services AGSwitzerlandContract manufacturercreos942026
Young Innovations IncUnited StatesContract manufacturerFULFILL Socket Preservation Plug · Salvin Orastruct232025
Park Dental Research CorpUnited StatesContract manufacturerStarGraft Granules · StarGraft Putty82026
J. Morita USA, Inc.United StatesForeign exporterFoundation422022
Olympus CorporationJapanForeign exporterKartush Hydroxlapatite Disks · Porous Hydroxlapatite granules12007
Sotera Health LLCUnited StatesContract manufacturerActifuse Shape (size 1-2mm/contents 1.6 mL) · Actifuse Shape (size 1-2mm/contents 15.8 mL) · Actifuse Shape (size 1-2mm/contents 2.6 mL) · Actifuse Shape (size 1-2mm/contents 8 mL) · +29——
Sweden & Martina INCUnited StatesListerECLIPSE——
STERIS CorporationUnited StatesContract sterilizerATRISORB®-D Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline · BiconDental1716 (NR) - SynthoGraft · MedtronicSofamore (AH) - BIPHASIC CALCIUM BO · Osteogene8842 (WH) - InRoad Dental Synthetic Bone Graft · +1——
HANSAMED LIMITED dba CITAGENIXCanadaForeign exporterEclipse · Eclipse Putty · PreservaRidge——
Epione BidcoFranceContract sterilizerRESORBA Synthetic Bone——
Midwest Sterilization Corp.United StatesContract sterilizerKartush hydroxylapatite disk 10mm · Kartush hydroxylapatite disk 14mm · Kartush hydroxylapatite disk 20mm · Kartush hydroxylapatite disk 7mm · +4——
Steritec Services LLCUnited StatesContract sterilizer———
Steritech, Inc.United StatesContract sterilizerD187800——
ZIMMER GmbHSwitzerlandForeign exporterENDOBON XENOGRAFT GRANULES——
GAMMATOM SrlItalyContract sterilizer———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Parter Sterilization Services / Parter Medical ProductsUnited StatesContract sterilizer———
Systagenix Wound Management Manufacturing LimitedUnited KingdomContract sterilizer———

510(k) clearances

Decided510(k)DeviceApplicant
6 Jul 2026K253317Cytrans™ ElashieldGC America Inc.
14 May 2026K253883Bonalive MaxillofacialBonalive Ltd
6 Mar 2026K251818BONTREE PLUSHudens Bio Co., Ltd.
17 Sep 2025K244006FG Bone Graft MFull Golden Biotech Co., Ltd.
29 Aug 2025K243745FG Bone Graft BFull Golden Biotech Co., Ltd.
21 Feb 2025K241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.
30 Dec 2022K213260CMFlexTMDimension Inx Corp.
4 Mar 2022K202675InRoad® Dental Synthetic Bone GraftOsteogene Tech Inc.
2 Oct 2020K201546OsOpia Synthetic Bone Void FillerRevisios BV
24 Sep 2020K201051Straumann BoneCeramicInstitut Straumann AG
17 Aug 2020K192597Cytrans GranulesGC America Inc.
14 Sep 2016K153676OSTEON IIIGENOSS Co., Ltd.
14 Jul 2016K153230ShefaBone SCPC Resorbable Bone GraftThe Implantech Inc./Shefabone
10 Jun 2014K140374MASTERGRAFT PUTTYMedtronic, Inc.
5 Dec 2013K121177BOND APATITEAugma Biomaterials
27 Sep 2013K131385EASY-GRAFTDegradable Solutions AG
20 Dec 2012K111105CURASAN OSSEOLIVE DENTALcurasan AG
20 Sep 2012K113282CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIORiemser Arzeimittel AG
21 Aug 2012K122240BONE PLUS BCP EAGLE EYEMegagen Implant Co., Ltd.
27 Jan 2012K113049SOCKET GRAFTSteiner Laboratories
17 Jan 2012K112716OSTEON IIGENOSS Co., Ltd.
22 Dec 2011K110198BLUE SKY BIO TCPBlue Sky Bio, LLC
16 Dec 2011K112428NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC
29 Nov 2011K111087FOUNDATIONOlympus Terumo Biomaterials Corporation
3 Nov 2011K103820REPROBONE DENTAL GRAFTING MATERIALCeramisys Ltd
13 May 2011K110449ENDOBON XENOGRAFT GRANULESBiomet 3i, LLC
6 May 2011K102208NANOGENOrthogen, LLC
20 Apr 2011K101827OSTEOSCAFTexas Innovative Medical Devices (Dba) Skeletal
10 Mar 2011K103709CERACELL DENTALcurasan AG
12 Jan 2011K102872OSBONE DENTALcurasan AG
21 Dec 2010K100883CARRIGENEtex Corp.
3 Dec 2010K102812GAMMA-BSM; BETA-BSM; EQUIVABONEEtex Corp.
19 Nov 2010K102015OSTEON, OSTEON SINUS, OSTEON LIFTINGGENOSS Co., Ltd.
26 Oct 2010K101718OSSEOCONDUCTSteiner Laboratories Div of Steiner Healthcare, LLC
21 Oct 2010K101014BOND BONEDentsply Sirona, Inc.
27 Sep 2010K091618VITOMATRIXOrthovita, Inc.
15 Sep 2010K101426CEROS TCP GRANULESMathys, Ltd.
2 Jul 2010K090950BONE PLUS BCPMegagen Implant Co., Ltd.
16 Jun 2010K092194POLYBONE DENTALKyung Won Medical Co., Ltd.
25 May 2010K093390HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025DePuy Spine, Inc.
22 Apr 2010K093871PERIOPHIL B-TCPCytophil, Inc
30 Mar 2010K100671NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC
15 Mar 2010K093122MBCP+Biomatlante
30 Dec 2009K092087MEDTRONIC DENTAL TCPMedtronic, Inc.
23 Dec 2009K091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEEtex Corp.
18 Dec 2009K092788PERIOPHIL BIPHASICCytophil, Inc
8 Dec 2009K083372ARROWBONE-A, ARROWBONE-BBrainbase Corporation
25 Nov 2009K092567MODIFICATION TO UNIGRAFTUnicare Biomedical, Inc.
30 Jul 2009K090850ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTEBaxter Healthcare Corp
15 Jun 2009K091484NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC
19 May 2009K090793BONGROS HABioalpha, Inc.
23 Mar 2009K090083CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090Unicare Biomedical, Inc.
17 Mar 2009K083858BOND BONEAugma Biomaterials
4 Mar 2009K083005NANGELTeknimed
24 Feb 2009K082286BIOACTYSGraftys
12 Feb 2009K083742SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIXCollagen Matrix, Inc.
9 Jan 2009K082917MASTERGRAFT RESORBABLE CERAMIC GRANULESMedtronic Sofamor Danek
17 Sep 2008K081784MASTERGRAFT PUTTYMedtronic Sofamor Danek
5 Sep 2008K082383FORTOSS VITALBiocomposites, Ltd.
29 Aug 2008K081432HEALOS II BONE GRAFT SUBSTITUTEDePuy Spine, Inc.
6 Aug 2008K081721TRICOS A RESORBABLE SUBSTITUTEBaxter Healthcare Corp
28 Jul 2008K081561OSFERION DOlympus Terumo Biomaterials Corporation
3 Jun 2008K080772BONEMEDIK-DMMeta Biomed Co, Ltd
14 Apr 2008K080308BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLDBioscaffold International Pte, Ltd.
8 Apr 2008K073571TRICOS T RESORBABLE BONE SUBSTITUTEBaxter Healthcare Corp
18 Oct 2007K072397SYNOSS SYNTHETIC BONE GRAFT MATERIALCollagen Matrix, Inc.
4 Sep 2007K071817OSTEOGRAF/N-300Dentsply Interntional
8 Aug 2007K072052OSTEOGRAF/D-300Dentsply International, Inc.
6 Aug 2007K072057OSTEOGRAF/LD-300Dentsply International, Inc.
6 Aug 2007K072056OSTEOGRAF/D-700Dentsply International, Inc.
3 Aug 2007K072058MODIFICATION TO: OSTEOGRAF/N-700Dentsply Interntional
24 Jul 2007K070784INION BIORESTOREBeijing Naton Technology Group Co. Ltd.
25 Jun 2007K070055BONALIVE GRANULES AND BONALIVE PLATESVivoxid , Ltd.
11 May 2007K063634RTR SYRINGESeptodont
24 Apr 2007K062834OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050GENOSS Co., Ltd.
16 Apr 2007K062102ODONCERTeknimed
22 Feb 2007K063596PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GELNovabone Products, LLC
12 Feb 2007K063549NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC
28 Nov 2006K063010REGEN BIOCEMENTSteiner Laboratories
9 Jun 2006K052493SOCKET GRAFTSteiner Laboratories
2 Jun 2006K060732MBCP GELBiomatlante
16 Mar 2006K060285BONEGEN - TRBio-Lok Intl., Inc.
21 Feb 2006K053374OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)Ossacur AG
14 Feb 2006K053387PERIOGLAS BONE GRAFT PARTICULATENovabone Products, LLC
23 Jan 2006K053022SYNTHES (USA) CHRONOS-BETA-TCPSynthes (Usa)
16 Sep 2005K051885MBCPBiomatlante
1 Sep 2005K051091SYNTHOGRAFTBicon, LLC
26 Aug 2005K050170FORTOSS VITAL BONE GRAFT SUBSTITUTEBiocomposites, Ltd.
11 Aug 2005K050984BIOPLANTKerr Dental Materials Center
22 Jul 2005K051443CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIOcurasan AG
19 Jul 2005K042583CALC-I-OSSUltradent Products, Inc.
15 Jul 2005K051381ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATEAce Surgical Supply Company, Inc.
15 Jul 2005K050260BIORESORB MACRO POREOraltronics Dental Implant Technology GmbH
14 Feb 2005K042730CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0GLifecore Biomedical, Inc.
6 Dec 2004K030052OSTIMHeraeus Kulzer, LLC
20 Oct 2004K042706OSSATURA DENTALSeaSpine Orthopedics Corporation
13 Oct 2004K040783FOUNDATIONTerumo Corp.
20 Aug 2004K031813OSSATURA DENTALIsotis NV
19 Jul 2004K041324CALMATRIX CALCIUM SULFATE BONE GRAFT BINDERLifecore Biomedical, Inc.
17 Jun 2004K030195BBP BONE SUBSTITUTESOct, USA, Inc.
3 May 2004K040646STRAUMANN GRANULESThe Straumann Co.
27 Apr 2004K033098OSTEOGEN SBRGImpladent , Ltd.
25 Mar 2004K033994NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTENovabone Products, LLC
17 Mar 2004K033729COLLAGEN DENTAL WOUND DRESSINGSCollagen Matrix, Inc.
1 Mar 2004K040278PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTENovabone Products, LLC
10 Dec 2003K033110C-GRAFTThe Clinician'S Preference, LLC
5 Nov 2003K031073PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTENovabone Products, LLC
27 Jun 2003K030682CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3Bioform, Inc.
26 Mar 2003K023998THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTETherics, Inc.
5 Feb 2003K023799FRIOS ALGIPOREFriadent GmbH
7 May 2002K020720OSSIFORMUnicare Biomedical, Inc.
10 Apr 2002K020396BIOCELLECT -PERIOImtec Corp.
28 Mar 2002K014289ORTHOSS RESORBABLE BONE VOID FILLERGeistlich Pharma AG
19 Dec 2001K013346GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANEW. L. Gore & Associates, Inc.
1 Oct 2001K012144CYTOFLEXUnicare Biomedical, Inc.
19 Sep 2001K0120473I CALCIUM SULFATE BONE CEMENTImplant Innovations, Inc.
11 Sep 2001K011403SURGIPLASTER CALCIUM SULFATE HEMIHYDRATEOrthogen, LLC
3 Jul 2001K011032SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULAHarvest Technologies, Corp.
12 Jun 2001K010775BIOCELLECTImtec Corp.
5 Jun 2001K010701MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLERMedtronic, Inc.
9 Apr 2001K003494MIMIX BONE REPLACEMENT SYSTEMZimmer Inc
1 Mar 2001K010320MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEMDepuyacromed
9 Feb 2001K0034933I CALCIUM SODIUM PHOSPHATE BONE CEMENTZimmer Inc
18 Jan 2001K003286SYMPHONY GRAFT DELIVERY SYSTEMDepuyacromed
9 Jan 2001K003457UNIGRAFTUnicare Biomedical, Inc.
13 Sep 2000K994137ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINEAtrix Laboratories, Inc.
22 Aug 2000K001598BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATIONCol-Bar , Ltd.
14 Aug 2000K970569BIO-BLOCKSGeistlich Pharma AG
25 May 2000K000633SYNTHETIC GLASS BONE GRAFT MATERIALBlue Sky Bio, LLC
2 Mar 2000K993610CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250Osteogenics Biomedical, Inc.
7 Feb 2000K000149NOVABONE-BIOGLASS BONE GRAFT PARTICULATEUsbiomaterials Corp.
27 Jan 2000K993784UNIGRAFTUnicare Biomedical, Inc.
14 Jan 2000K993238FORTOSS-CEMABiocomposites, Ltd.
19 Nov 1999K990537OSTEO-PIN MEMBRANE FIXATION PINLuitpold Pharmaceuticals, Inc.
15 Oct 1999K992416PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATEUsbiomaterials Corp.
26 Jul 1999K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANEIntegra LifeSciences Corporation
12 Feb 1999K983104NORIAN PERIODONTAL/DENTAL CEMENT (PDC)Norian Corp.
20 Oct 1998K982699UNIGRAFEUnicare Biomedical, Inc.
16 Sep 1998K974399BIO-OSS COLLAGENGeistlich Pharma AG
15 Sep 1998K970321BIO-OSS ANORGANIC BOVINE BONEGeistlich Pharma AG
24 Jul 1998K972817RESOR-PIN RESORBABLE MEMBRANE PINGeistlich Pharma AG
2 Jul 1998K981182OSTEOGRAF/N-300Ceramed Dental, LLC
26 Jun 1998K981214OSTEOGRAF/N-700Ceramed Dental, LLC
3 Apr 1998K980679ENDOBONZimmer Inc
17 Dec 1997K973594GORE RESOLUT XT REGENERATIVE MATERIALW. L. Gore & Associates, Inc.
30 Oct 1997K972842INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGEInterpore Intl.
6 Aug 1997K972278CYTOPLAST REGENTEX TITANIUM 250Osteogenics Co.
5 Aug 1997K962548BSM BONE SUBSTITUTE MATERIAL KITEtex Corp.
8 May 1997K970884RESOLUT REGENERATIVE MATERIALW. L. Gore & Associates, Inc.
11 Mar 1997K964342CYTOPLAST GBROsteogenics Co.
5 Nov 1996K960267TBM SPONGEBiocoll Laboratories, Inc.
15 Oct 1996K940643OSMED EPI-GUIDEThm Biomedical, Inc.
3 Oct 1996K962624RESOLUT REGENERATIVE MATERIALW. L. Gore & Associates, Inc.
20 Sep 1996K962494PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATEUsbiomaterials Corp.
20 Aug 1996K962838PERMARIDGE SYRINGECeramed Corp.
1 Aug 1996K962786OSTEOGRAF STAINLESS STEEL SYRINGCeramed Corp.
22 Apr 1996K960348OSTEOGRAF/N-300 HYDROXYLAPATITECeramed Corp.
18 Apr 1996K960368OSTEOGRAFT/N-700 HYDROXYLAPTITECeramed Corp.
18 Apr 1996K960353OSTEOGRAF/LD-300 HYDROXYLAPATITECeramed Corp.
15 Apr 1996K960361PERMAMESH-D HYDROXYLAPATITE MATRIXCeramed Corp.
10 Apr 1996K960164BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140Bio-Interfaces, Inc.
6 Feb 1996K950306IMTEC BIOBARRIERImtec Corp.
23 Jan 1996K955096CAPSET CALCIUM SULFATE BONE GRAFT PLASTERLifecore Biomedical, Inc.
4 Jan 1996K954763BIO-INTERFACES, INC,. BII-PLASTBio-Interfaces, Inc.
2 Jan 1996K954631OSTEOGRAF/N-BLOCCK HYDROXYLAPATITECeramed Corp.
19 Dec 1995K952922BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIALOrthovita, Inc.
28 Aug 1995K952619BIO-OSS CERAMICGeistlich Pharma AG
28 Aug 1995K952618BIO-OSSGeistlich Pharma AG
23 Aug 1995K950598BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFTBio-Interfaces, Inc.
22 Aug 1995K924408COLLA-TEC ABSORBABLE COLLAGEN MEMBRANEColla-Tec, Inc.
7 Aug 1995K952617BIO-OSSGeistlich Pharma AG
31 May 1995K923310OSTEOGEN (HA RESORB)Impladent , Ltd.
9 May 1995K950567BIO-APATITE 6140 HA PARTICLESBio-Interfaces, Inc.
27 Apr 1995K950511BLL-FIL 6140 PARTICLESBio-Interfaces, Inc.
10 Apr 1995K943186CAPSET CALCIUM SULFATE BONE GRAFT PLASTERLifecore Biomedical, Inc.
28 Mar 1995K950165INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONSInterpore Intl.
28 Mar 1995K932866RESOLUT REGENERATIVE MATERIALW. L. Gore & Associates, Inc.
10 Feb 1995K941780ORTHOVITA BIOGRANOrthovita, Inc.
5 Oct 1994K942946OSTEOGRAF/D-100 HYDROXYLAPATITECeramed Corp.
23 Aug 1994K942212OSTEOGRAF/LD-300 HYDROXYLAPATITECeramed Corp.
19 Jul 1994K934049BII-PORE(TM) CANAL WALL PROSTHESISBio-Interfaces, Inc.
19 Jul 1994K933688BII-POREBio-Interfaces, Inc.
18 May 1994K934430BON APATITE HA PARTICLESBio-Interfaces, Inc.
26 Jan 1994K934947BII-PLASTBio-Interfaces, Inc.
4 Nov 1993K930115PERIOGLASSUsbiomaterials Corp.
30 Apr 1993K924287710 POROUS HA PARTICLES-BII-POREBio-Interfaces, Inc.
14 Apr 1993K924288B1018 POROUS HA BII-POREBio-Interfaces, Inc.
14 Apr 1993K9242864060 POROUS HA PARTICULES BII POREBio-Interfaces, Inc.
14 Apr 1993K922487BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-POREBio-Interfaces, Inc.
4 Dec 1992K9217761840 HA PARTICLESBio-Interfaces, Inc.
24 Nov 1992K920508BIO-OSS BLOCKSGeistlich Pharma AG
21 Aug 1992K921468PERMAMESH HYDROXYLAPATITE MATRIXCeramed Corp.
25 Jun 1992K921469OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESHCeramed Corp.
1 May 1991K910432HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLifecore Biomedical, Inc.
29 Jan 1991K900136CEROS 80 (HA)Mathys, Ltd.
11 Dec 1990K902295OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESHCeramed Corp.
1 Sep 1989K891173OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60Ceramed Corp.
11 Jan 1989K8850674060 HA PARTICLESBio-Interfaces, Inc.
18 Nov 1988K880371BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINERAmerican Biomaterials Corp.
13 Jun 1988K882098DENTORIDGE(TM) HYDROXYYLAPATITENorian Corp.

Showing the 200 most recent of 231.

Official records: FDA product classification for LYC · 21 CFR 872.3930.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026