Product Code: LYC FDA class 2 21 CFR 872.3930

Bone Grafting Material, Synthetic

Dental

The Synthetic Bone Grafting Material (product code LYC) is a synthetically derived implantable dental device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and bony defects of the upper or lower jaw, supporting bone regeneration and dental implant placement. Regulated under 21 CFR 872.3930 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant. The device falls under the Dental medical specialty and is reviewed under the Dental (DE) panel. It is not life-sustaining.

View on FDA

510(k)s

230

FEI Numbers

Registration Numbers

Unique Applicants

117

Years Active

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Basic Information

Product Code: LYC
Device Class: FDA class 2
Regulation Number: 872.3930
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 230 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253883	Bonalive Maxillofacial	May 14, 2026	Substantially Equivalent	Bonalive , Ltd.
K251818	BONTREE PLUS	Mar 06, 2026	Substantially Equivalent	Hudens Bio Co., Ltd.
K244006	FG Bone Graft M	Sep 17, 2025	Substantially Equivalent	Full Golden Biotech Co., Ltd.
K243745	FG Bone Graft B	Aug 29, 2025	Substantially Equivalent	Full Golden Biotech Corporation
K241186	Synthetic Bone Graft Particulate	Feb 21, 2025	Substantially Equivalent	Shenzhen Dazhou Medical Technology Co., Ltd.
K213260	CMFlexTM	Dec 30, 2022	Substantially Equivalent	Dimension Inx Corp.
K202675	InRoad® Dental Synthetic Bone Graft	Mar 04, 2022	Substantially Equivalent	Osteogene Tech Corp
K201546	OsOpia Synthetic Bone Void Filler	Oct 02, 2020	Substantially Equivalent	Revisios BV
K201051	Straumann BoneCeramic	Sep 24, 2020	Substantially Equivalent	Institut Straumann AG
K192597	Cytrans Granules	Aug 17, 2020	Substantially Equivalent	GC America, Inc.
K153676	OSTEON III	Sep 14, 2016	Substantially Equivalent	Genoss Co., Ltd.
K153230	ShefaBone SCPC Resorbable Bone Graft	Jul 14, 2016	Substantially Equivalent	The Implantech Inc./Shefabone
K140374	MASTERGRAFT PUTTY	Jun 10, 2014	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K121177	BOND APATITE	Dec 05, 2013	Substantially Equivalent	Augma Biomaterials, Ltd.
K131385	EASY-GRAFT	Sep 27, 2013	Substantially Equivalent	Degradable Solutions AG
K111105	CURASAN OSSEOLIVE DENTAL	Dec 20, 2012	Substantially Equivalent	Curasan AG
K113282	CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO	Sep 20, 2012	Substantially Equivalent	Riemser Arzeimittel AG
K122240	BONE PLUS BCP EAGLE EYE	Aug 21, 2012	Substantially Equivalent	Megagen Implant Co., Ltd.
K113049	SOCKET GRAFT	Jan 27, 2012	Substantially Equivalent	Steiner Laboratories
K112716	OSTEON II	Jan 17, 2012	Substantially Equivalent	Genoss Co., Ltd.
K110198	BLUE SKY BIO TCP	Dec 22, 2011	Substantially Equivalent	Blue Sky Bio, LLC
K112428	NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT	Dec 16, 2011	Substantially Equivalent	Novabone Products, LLC
K111087	FOUNDATION	Nov 29, 2011	Substantially Equivalent	Olympus Terumo Biomaterials Corporation
K103820	REPROBONE DENTAL GRAFTING MATERIAL	Nov 03, 2011	Substantially Equivalent	Ceramisys, Ltd.
K110449	ENDOBON XENOGRAFT GRANULES	May 13, 2011	Substantially Equivalent	Biomet 3i
K102208	NANOGEN	May 06, 2011	Substantially Equivalent	Orthogen, LLC
K101827	OSTEOSCAF	Apr 20, 2011	Substantially Equivalent	Texas Innovative Medical Devices (Dba) Skeletal
K103709	CERACELL DENTAL	Mar 10, 2011	Substantially Equivalent	Curasan AG
K102872	OSBONE DENTAL	Jan 12, 2011	Substantially Equivalent	Curasan AG
K100883	CARRIGEN	Dec 21, 2010	Substantially Equivalent	Etex Corp.
K102812	GAMMA-BSM; BETA-BSM; EQUIVABONE	Dec 03, 2010	Substantially Equivalent	Etex Corporation
K102015	OSTEON, OSTEON SINUS, OSTEON LIFTING	Nov 19, 2010	Substantially Equivalent	Genoss Co., Ltd.
K101718	OSSEOCONDUCT	Oct 26, 2010	Substantially Equivalent	Steiner Laboratories Div of Steiner Healthcare, LLC
K101014	BOND BONE	Oct 21, 2010	Substantially Equivalent	Mis Implants Technologies , Ltd.
K091618	VITOMATRIX	Sep 27, 2010	Substantially Equivalent	Orthovita, Inc.
K101426	CEROS TCP GRANULES	Sep 15, 2010	Substantially Equivalent	Mathys, Ltd.
K090950	BONE PLUS BCP	Jul 02, 2010	Substantially Equivalent	Megagen Implant Co., Ltd.
K092194	POLYBONE DENTAL	Jun 16, 2010	Substantially Equivalent	Kyung Won Medical Co., Ltd.
K093390	HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025	May 25, 2010	Substantially Equivalent	Depuy Spine, Inc.
K093871	PERIOPHIL B-TCP	Apr 22, 2010	Substantially Equivalent	Cytophil, Inc.
K100671	NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT	Mar 30, 2010	Substantially Equivalent	Novabone Products, LLC
K093122	MBCP+	Mar 15, 2010	Substantially Equivalent	Biomatlante
K092087	MEDTRONIC DENTAL TCP	Dec 30, 2009	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K091729	ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE	Dec 23, 2009	Substantially Equivalent	Etex Corp.
K092788	PERIOPHIL BIPHASIC	Dec 18, 2009	Substantially Equivalent	Cytophil, Inc.
K083372	ARROWBONE-A, ARROWBONE-B	Dec 08, 2009	Substantially Equivalent	Brainbase Corporation
K092567	MODIFICATION TO UNIGRAFT	Nov 25, 2009	Substantially Equivalent	Unicare Biomedical, Inc.
K090850	ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE	Jul 30, 2009	Substantially Equivalent	Apatech , Ltd.
K091484	NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT	Jun 15, 2009	Substantially Equivalent	Novabone Products, LLC
K090793	BONGROS HA	May 19, 2009	Substantially Equivalent	Bioalpha, Inc.
K090083	CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090	Mar 23, 2009	Substantially Equivalent	Unicare Biomedical, Inc.
K083858	BOND BONE	Mar 17, 2009	Substantially Equivalent	Augma Biomaterials, Ltd.
K083005	NANGEL	Mar 04, 2009	Substantially Equivalent	Teknimed, S.A.
K082286	BIOACTYS	Feb 24, 2009	Substantially Equivalent	Graftys
K083742	SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX	Feb 12, 2009	Substantially Equivalent	Collagen Matrix, Inc.
K082917	MASTERGRAFT RESORBABLE CERAMIC GRANULES	Jan 09, 2009	Substantially Equivalent	Medtronic Sofamor Danek
K081784	MASTERGRAFT PUTTY	Sep 17, 2008	Substantially Equivalent	Medtronic Sofamor Danek
K082383	FORTOSS VITAL	Sep 05, 2008	Substantially Equivalent	Biocomposites, Ltd.
K081432	HEALOS II BONE GRAFT SUBSTITUTE	Aug 29, 2008	Substantially Equivalent	Depuy Spine, Inc.
K081721	TRICOS A RESORBABLE SUBSTITUTE	Aug 06, 2008	Substantially Equivalent	Baxter Healthcare Corp
K081561	OSFERION D	Jul 28, 2008	Substantially Equivalent	Olympus Terumo Biomaterials Corporation
K080772	BONEMEDIK-DM	Jun 03, 2008	Substantially Equivalent	Meta Biomed Co., Ltd.
K080308	BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD	Apr 14, 2008	Substantially Equivalent	Bioscaffold International Pte, Ltd.
K073571	TRICOS T RESORBABLE BONE SUBSTITUTE	Apr 08, 2008	Substantially Equivalent	Baxter Healthcare Corporation
K072397	SYNOSS SYNTHETIC BONE GRAFT MATERIAL	Oct 18, 2007	Substantially Equivalent	Collagen Matrix, Inc.
K071817	OSTEOGRAF/N-300	Sep 04, 2007	Substantially Equivalent	Dentsply Interntional
K072052	OSTEOGRAF/D-300	Aug 08, 2007	Substantially Equivalent	Dentsply International, Inc.
K072057	OSTEOGRAF/LD-300	Aug 06, 2007	Substantially Equivalent	Dentsply International, Inc.
K072056	OSTEOGRAF/D-700	Aug 06, 2007	Substantially Equivalent	Dentsply International, Inc.
K072058	MODIFICATION TO: OSTEOGRAF/N-700	Aug 03, 2007	Substantially Equivalent	Dentsply Interntional
K070784	INION BIORESTORE	Jul 24, 2007	Substantially Equivalent	Inion OY
K070055	BONALIVE GRANULES AND BONALIVE PLATES	Jun 25, 2007	Substantially Equivalent	Vivoxid , Ltd.
K063634	RTR SYRINGE	May 11, 2007	Substantially Equivalent	Septodont
K062834	OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050	Apr 24, 2007	Substantially Equivalent	Genoss Co., Ltd.
K062102	ODONCER	Apr 16, 2007	Substantially Equivalent	Teknimed, S.A.
K063596	PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL	Feb 22, 2007	Substantially Equivalent	Novabone Products, LLC
K063549	NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT	Feb 12, 2007	Substantially Equivalent	Novabone Products, LLC
K063010	REGEN BIOCEMENT	Nov 28, 2006	Substantially Equivalent	Steiner Laboratories
K052493	SOCKET GRAFT	Jun 09, 2006	Substantially Equivalent	Steiner Laboratories
K060732	MBCP GEL	Jun 02, 2006	Substantially Equivalent	Biomatlante
K060285	BONEGEN - TR	Mar 16, 2006	Substantially Equivalent	Bio-Lok Intl., Inc.
K053374	OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)	Feb 21, 2006	Substantially Equivalent	Ossacur AG
K053387	PERIOGLAS BONE GRAFT PARTICULATE	Feb 14, 2006	Substantially Equivalent	Novabone Products, LLC
K053022	SYNTHES (USA) CHRONOS-BETA-TCP	Jan 23, 2006	Substantially Equivalent	Synthes (Usa)
K051885	MBCP	Sep 16, 2005	Substantially Equivalent	Biomatlante
K051091	SYNTHOGRAFT	Sep 01, 2005	Substantially Equivalent	Bicon, Inc.
K050170	FORTOSS VITAL BONE GRAFT SUBSTITUTE	Aug 26, 2005	Substantially Equivalent	Biocomposites, Ltd.
K050984	BIOPLANT	Aug 11, 2005	Substantially Equivalent	Kerr Dental Materials Center
K051443	CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO	Jul 22, 2005	Substantially Equivalent	Curasan Ag, Frankfurt Facility
K042583	CALC-I-OSS	Jul 19, 2005	Substantially Equivalent	Ultradent Products, Inc.
K051381	ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE	Jul 15, 2005	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K050260	BIORESORB MACRO PORE	Jul 15, 2005	Substantially Equivalent	Oraltronics Dental Implant Technology GmbH
K042730	CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G	Feb 14, 2005	Substantially Equivalent	Lifecorebiomedical
K030052	OSTIM	Dec 06, 2004	Substantially Equivalent	Heraeus Kulzer, Inc.
K042706	OSSATURA DENTAL	Oct 20, 2004	Substantially Equivalent	Isotis Orthobiologics, Inc.
K040783	FOUNDATION	Oct 13, 2004	Substantially Equivalent	Terumo Corp.
K031813	OSSATURA DENTAL	Aug 20, 2004	Substantially Equivalent	Isotis NV
K041324	CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER	Jul 19, 2004	Substantially Equivalent	Lifecore Biomedical, Inc.
K030195	BBP BONE SUBSTITUTES	Jun 17, 2004	Substantially Equivalent	Oct, USA, Inc.
K040646	STRAUMANN GRANULES	May 03, 2004	Substantially Equivalent	The Straumann Co.
K033098	OSTEOGEN SBRG	Apr 27, 2004	Substantially Equivalent	Impladent , Ltd.
K033994	NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE	Mar 25, 2004	Substantially Equivalent	Novabone Products, LLC
K033729	COLLAGEN DENTAL WOUND DRESSINGS	Mar 17, 2004	Substantially Equivalent	Collagen Matrix, Inc.
K040278	PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE	Mar 01, 2004	Substantially Equivalent	Novabone Products, LLC
K033110	C-GRAFT	Dec 10, 2003	Substantially Equivalent	The Clinician'S Preference, LLC
K031073	PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE	Nov 05, 2003	Substantially Equivalent	Novabone Products, LLC
K030682	CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3	Jun 27, 2003	Substantially Equivalent	Bioform, Inc.
K023998	THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE	Mar 26, 2003	Substantially Equivalent	Therics, Inc.
K023799	FRIOS ALGIPORE	Feb 05, 2003	Substantially Equivalent	Friadent GmbH
K020720	OSSIFORM	May 07, 2002	Substantially Equivalent	Unicare Biomedical, Inc.
K020396	BIOCELLECT -PERIO	Apr 10, 2002	Substantially Equivalent	Imtec Corp.
K014289	ORTHOSS RESORBABLE BONE VOID FILLER	Mar 28, 2002	Substantially Equivalent	Geistlich-Pharma
K013346	GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE	Dec 19, 2001	Substantially Equivalent	W. L. Gore & Associates, Inc.
K012144	CYTOFLEX	Oct 01, 2001	Substantially Equivalent	Unicare Biomedical, Inc.
K012047	3I CALCIUM SULFATE BONE CEMENT	Sep 19, 2001	Substantially Equivalent	Implant Innovations, Inc.
K011403	SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE	Sep 11, 2001	Substantially Equivalent	Orthogen Corp.
K011032	SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA	Jul 03, 2001	Substantially Equivalent	Harvest Technologies, Corp.
K010775	BIOCELLECT	Jun 12, 2001	Substantially Equivalent	Imtec Corp.
K010701	MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER	Jun 05, 2001	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.
K003494	MIMIX BONE REPLACEMENT SYSTEM	Apr 09, 2001	Substantially Equivalent	Biomet, Inc.
K010320	MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM	Mar 01, 2001	Substantially Equivalent	Depuyacromed
K003493	3I CALCIUM SODIUM PHOSPHATE BONE CEMENT	Feb 09, 2001	Substantially Equivalent	Biomet, Inc.
K003286	SYMPHONY GRAFT DELIVERY SYSTEM	Jan 18, 2001	Substantially Equivalent	Depuyacromed
K003457	UNIGRAFT	Jan 09, 2001	Substantially Equivalent	Unicare Biomedical
K994137	ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE	Sep 13, 2000	Substantially Equivalent	Atrix Laboratories, Inc.
K001598	BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION	Aug 22, 2000	Substantially Equivalent	Col-Bar , Ltd.
K970569	BIO-BLOCKS	Aug 14, 2000	Substantially Equivalent	Geistlich-Pharma
K000633	SYNTHETIC GLASS BONE GRAFT MATERIAL	May 25, 2000	Substantially Equivalent	Blue Sky Bio
K993610	CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250	Mar 02, 2000	Substantially Equivalent	Osteogenics Biomedical, Inc.
K000149	NOVABONE-BIOGLASS BONE GRAFT PARTICULATE	Feb 07, 2000	Substantially Equivalent	Usbiomaterials Corp.
K993784	UNIGRAFT	Jan 27, 2000	Substantially Equivalent	Unicare Biomedical
K993238	FORTOSS-CEMA	Jan 14, 2000	Substantially Equivalent	Biocomposites, Ltd.
K990537	OSTEO-PIN MEMBRANE FIXATION PIN	Nov 19, 1999	Substantially Equivalent	Luitpold Pharmaceuticals, Inc.
K992416	PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE	Oct 15, 1999	Substantially Equivalent	Usbiomaterials Corp.
K992216	BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE	Jul 26, 1999	Substantially Equivalent	Integra Lifesciences Corp.
K983104	NORIAN PERIODONTAL/DENTAL CEMENT (PDC)	Feb 12, 1999	Substantially Equivalent	Norian Corp.
K982699	UNIGRAFE	Oct 20, 1998	Substantially Equivalent	Unicare Biomedical
K974399	BIO-OSS COLLAGEN	Sep 16, 1998	Substantially Equivalent	Geistlich-Pharma
K970321	BIO-OSS ANORGANIC BOVINE BONE	Sep 15, 1998	Substantially Equivalent	Geistlich-Pharma
K972817	RESOR-PIN RESORBABLE MEMBRANE PIN	Jul 24, 1998	Substantially Equivalent	Geistlich-Pharma
K981182	OSTEOGRAF/N-300	Jul 02, 1998	Substantially Equivalent	Ceramed Dental, LLC
K981214	OSTEOGRAF/N-700	Jun 26, 1998	Substantially Equivalent	Ceramed Dental, LLC
K980679	ENDOBON	Apr 03, 1998	Substantially Equivalent	Biomet, Inc.
K973594	GORE RESOLUT XT REGENERATIVE MATERIAL	Dec 17, 1997	Substantially Equivalent	W. L. Gore & Associates, Inc.
K972842	INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE	Oct 30, 1997	Substantially Equivalent	Interpore Intl.
K972278	CYTOPLAST REGENTEX TITANIUM 250	Aug 06, 1997	Substantially Equivalent	Osteogenics Co.
K962548	BSM BONE SUBSTITUTE MATERIAL KIT	Aug 05, 1997	Substantially Equivalent	Etex Corp.
K970884	RESOLUT REGENERATIVE MATERIAL	May 08, 1997	Substantially Equivalent	W. L. Gore & Associates, Inc.
K964342	CYTOPLAST GBR	Mar 11, 1997	Substantially Equivalent	Osteogenics Co.
K960267	TBM SPONGE	Nov 05, 1996	Substantially Equivalent	Biocoll Laboratories, Inc.
K940643	OSMED EPI-GUIDE	Oct 15, 1996	Substantially Equivalent	Thm Biomedical, Inc.
K962624	RESOLUT REGENERATIVE MATERIAL	Oct 03, 1996	Substantially Equivalent	W. L. Gore & Associates, Inc.
K962494	PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE	Sep 20, 1996	Substantially Equivalent	Usbiomaterials Corp.
K962838	PERMARIDGE SYRINGE	Aug 20, 1996	Substantially Equivalent	Ceramed Corp.
K962786	OSTEOGRAF STAINLESS STEEL SYRING	Aug 01, 1996	Substantially Equivalent	Ceramed Corp.
K960348	OSTEOGRAF/N-300 HYDROXYLAPATITE	Apr 22, 1996	Substantially Equivalent	Ceramed Corp.
K960368	OSTEOGRAFT/N-700 HYDROXYLAPTITE	Apr 18, 1996	Substantially Equivalent	Ceramed Corp.
K960353	OSTEOGRAF/LD-300 HYDROXYLAPATITE	Apr 18, 1996	Substantially Equivalent	Ceramed Corp.
K960361	PERMAMESH-D HYDROXYLAPATITE MATRIX	Apr 15, 1996	Substantially Equivalent	Ceramed Corp.
K960164	BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140	Apr 10, 1996	Substantially Equivalent	Bio-Interfaces, Inc.
K950306	IMTEC BIOBARRIER	Feb 06, 1996	Substantially Equivalent	Imtec Corp.
K955096	CAPSET CALCIUM SULFATE BONE GRAFT PLASTER	Jan 23, 1996	Substantially Equivalent	Lifecore Biomedical, Inc.
K954763	BIO-INTERFACES, INC,. BII-PLAST	Jan 04, 1996	Substantially Equivalent	Bio-Interfaces, Inc.
K954631	OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE	Jan 02, 1996	Substantially Equivalent	Ceramed Corp.
K952922	BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL	Dec 19, 1995	Substantially Equivalent	Orthovita Co.
K952619	BIO-OSS CERAMIC	Aug 28, 1995	Substantially Equivalent	Geistlich-Pharma
K952618	BIO-OSS	Aug 28, 1995	Substantially Equivalent	Geistlich-Pharma
K950598	BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT	Aug 23, 1995	Substantially Equivalent	Bio-Interfaces, Inc.
K924408	COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE	Aug 22, 1995	Substantially Equivalent	Colla-Tec, Inc.
K952617	BIO-OSS	Aug 07, 1995	Substantially Equivalent	Geistlich-Pharma
K923310	OSTEOGEN (HA RESORB)	May 31, 1995	Substantially Equivalent	Impladent
K950567	BIO-APATITE 6140 HA PARTICLES	May 09, 1995	Substantially Equivalent	Bio-Interfaces, Inc.
K950511	BLL-FIL 6140 PARTICLES	Apr 27, 1995	Substantially Equivalent	Bio-Interfaces, Inc.
K943186	CAPSET CALCIUM SULFATE BONE GRAFT PLASTER	Apr 10, 1995	Substantially Equivalent	Lifecore Biomedical, Inc.
K950165	INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS	Mar 28, 1995	Substantially Equivalent	Interpore Intl.
K932866	RESOLUT REGENERATIVE MATERIAL	Mar 28, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K941780	ORTHOVITA BIOGRAN	Feb 10, 1995	Substantially Equivalent	Orthovita Co.
K942946	OSTEOGRAF/D-100 HYDROXYLAPATITE	Oct 05, 1994	Substantially Equivalent	Ceramed Corp.
K942212	OSTEOGRAF/LD-300 HYDROXYLAPATITE	Aug 23, 1994	Substantially Equivalent	Ceramed Corp.
K934049	BII-PORE(TM) CANAL WALL PROSTHESIS	Jul 19, 1994	Substantially Equivalent	Bio-Interfaces, Inc.
K933688	BII-PORE	Jul 19, 1994	Substantially Equivalent	Bio-Interfaces, Inc.
K934430	BON APATITE HA PARTICLES	May 18, 1994	Substantially Equivalent	Bio-Interfaces, Inc.
K934947	BII-PLAST	Jan 26, 1994	Substantially Equivalent	Bio-Interfaces, Inc.
K930115	PERIOGLASS	Nov 04, 1993	Substantially Equivalent	Usbiomaterials Corp.
K924287	710 POROUS HA PARTICLES-BII-PORE	Apr 30, 1993	Substantially Equivalent	Bio-Interfaces, Inc.
K924288	B1018 POROUS HA BII-PORE	Apr 14, 1993	Substantially Equivalent	Bio-Interfaces, Inc.
K924286	4060 POROUS HA PARTICULES BII PORE	Apr 14, 1993	Substantially Equivalent	Bio-Interfaces, Inc.
K922487	BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE	Apr 14, 1993	Substantially Equivalent	Bio-Interfaces, Inc.
K921776	1840 HA PARTICLES	Dec 04, 1992	Substantially Equivalent	Bio-Interfaces, Inc.
K920508	BIO-OSS BLOCKS	Nov 24, 1992	Substantially Equivalent	Geistlich-Pharma
K921468	PERMAMESH HYDROXYLAPATITE MATRIX	Aug 21, 1992	Substantially Equivalent for Some Indications	Ceramed Corp.
K921469	OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH	Jun 25, 1992	Substantially Equivalent	Ceramed Corp.
K910432	HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER	May 01, 1991	Substantially Equivalent	Lifecore Biomedical, Inc.
K900136	CEROS 80 (HA)	Jan 29, 1991	Substantially Equivalent	Mathys Corp.
K902295	OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH	Dec 11, 1990	Substantially Equivalent	Ceramed Corp.
K891173	OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60	Sep 01, 1989	Substantially Equivalent	Ceramed Corp.
K885067	4060 HA PARTICLES	Jan 11, 1989	Substantially Equivalent	Bio-Interfaces, Inc.
K880371	BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER	Nov 18, 1988	Substantially Equivalent	American Biomaterials Corp.
K882098	DENTORIDGE(TM) HYDROXYYLAPATITE	Jun 13, 1988	Substantially Equivalent	Norian Corp.
K873763	BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE	Dec 08, 1987	Substantially Equivalent	Geistlich-Pharma
K871773	BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT	Aug 24, 1987	Substantially Equivalent for Some Indications	Geistlich-Pharma
K863237	HYDROXYLAPATITE BONE GRAFT MATERIAL	Dec 29, 1986	Substantially Equivalent	Richards Medical Co., Inc.
K863176	ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+	Nov 26, 1986	Substantially Equivalent for Some Indications	Coors Biomedical Co.
K862324	OSTEOGRAF/AR AND OSTEOGRAF/AR+	Aug 15, 1986	Substantially Equivalent	Coors Biomedical Co.
K862061	OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40	Jul 29, 1986	Substantially Equivalent	Coors Biomedical Co.
K861041	ENHANCE	May 30, 1986	Substantially Equivalent	Packaging Technologies, Inc.
K860983	INTERPORE 200 POROUS HYDROXYAPATITE	May 23, 1986	Substantially Equivalent	Interpore Intl.
K861084	OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH	Apr 30, 1986	Substantially Equivalent	Coors Biomedical Co.
K861083	OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH	Apr 30, 1986	Substantially Equivalent	Coors Biomedical Co.
K852766	HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI	Oct 21, 1985	Substantially Equivalent	Orthomatrix, Inc.
K852199	OSTEOGRAF 2040 OSTEOGRAF 4060	Oct 07, 1985	Substantially Equivalent	Osteotech, Inc.
K852742	OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40	Sep 26, 1985	Substantially Equivalent	Coors Biomedical Co.
K852765	HA-2000 HYDROXYLAPATITE	Sep 23, 1985	Substantially Equivalent	Orthomatrix, Inc.
K852682	CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG	Sep 23, 1985	Substantially Equivalent	Calcitek, Inc.
K850012	ALLOTROPAT/HEYLTEX CORP. BONE GRAFTING DENSE HYDRO	Apr 22, 1985	Substantially Equivalent	Heyltex Corp.
K843398	OSTEOGEN	Dec 27, 1984	Substantially Equivalent	Impladent
K842718	HYDROXYAPATITE	Nov 07, 1984	Substantially Equivalent	Depuy, Inc.
K843154	TOOTH ROOT SOCKET GAUGE	Oct 01, 1984	Substantially Equivalent	Interpore Intl.
K843153	ANTERIOR ALVEOLAR RIDGE SIZER	Sep 27, 1984	Substantially Equivalent	Interpore Intl.
K842163	RIDGEMATRIX 20/40 MESH, PERIOMATRIX	Aug 09, 1984	Substantially Equivalent	Orthomatrix, Inc.
K841201	POROUS HYDROXYAPATITE BG200	Aug 03, 1984	Substantially Equivalent	Interpore Intl.
K840260	PERIOGRAF DURAPATITE 40-60 MESH	Apr 05, 1984	Substantially Equivalent	Sterling Drug, Inc.
K832509	MBS HARD TISSUE REPLACEMENT SYSTEM	Nov 29, 1983	Substantially Equivalent	Medical Biological Sciences, Inc.
K830304	REPLAM HYDROXYAPATITE	Apr 06, 1983	Substantially Equivalent	Replam Corp.
K821752	SYNTHOGRAFT LG-AUGMENTATION & BONE FILL	Aug 12, 1982	Substantially Equivalent	Depuy, Inc.
K820023	CONAGRAF TM DURAPATITE CONES	Feb 24, 1982	Substantially Equivalent	Sterling Drug, Inc.
K813070	PERIOGRAF	Nov 20, 1981	Substantially Equivalent	Sterling Drug, Inc.
K811101	HYDROXYLAPATITE	Nov 20, 1981	Substantially Equivalent	Carbomedics, Inc.
K810382	HYDROXYLAPATITE ALVEOLAR RIDGE MAIN	Mar 20, 1981	Substantially Equivalent	Carbomedics, Inc.
K791416	PYROLITE CARBON ALVEOLAR MAINTEN IMPLANT	Oct 09, 1979	Substantially Equivalent	Carbomedics, Inc.