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Prosthetic devices · 21 CFR 872 Subpart D

Animal Source Bone Grafting Material

A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.

FDA codeNPMClass221 CFR872.3930Pathway510(k)ImplantCategoryBone grafts & membranes
Companies listing it
3921 makers
Brands and models
88
510(k) clearances
4211 in five years
FDA name
Bone Grafting Material, Animal Source
2004: 12005: 12009: 12010: 22011: 32012: 22013: 22014: 22015: 42016: 12017: 52018: 22020: 32021: 22023: 22024: 32025: 32026: 319801990200020102020

510(k) clearances per year, 1976–2026

Companies that list NPM

39 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerStraumann XenoGraft2122026
Osstem Implant Co., Ltd.South KoreaMakerA-Graft682026
Geistlich Pharma AGSwitzerlandMakerCombi-Kit Collagen · Geistlich Bio-Gide® · Geistlich Bio-Gide® Compressed · Geistlich Bio-Gide® Forte · +10302025
Hiossen Inc.United StatesMakerA-Graft262026
Meta Biomed Co, LtdUnited StatesMakerBoneMedik-DM · Renew-Cera242024
PURGO BIOLOGICS Inc.South KoreaMakerTHE Graft · THE Graft Collagen52024
SigmaGraft, Inc.United StatesMakerInterOss · InterOss Collagen · Maxxeus · Maxxeus Dental Xenograft Particulates · +132023
MEDPARK.Co., Ltd.South KoreaMakerEndobon® Bovine Xenograft Moldable · Endobon® Bovine Xenograft Particulate22026
Collagen Matrix, Inc.United StatesMakerMatrixOss Granules · MatrixOss Syringe · SynOss Plug · X-GEN Granules · +1202024
WishboneBelgiumMakerW-Bone · Wishbone HA · Wishbone HAE22026
Aroa Biosurgery LtdNew ZealandMakerAroa Dental Membrane · Endoform Dental Membrane12024
botiss biomaterials GmbHGermanyMakercerabone · Straumann cerabone12025
Medtronic, Inc.United StatesMakerMASTERGRAFT Putty112014
Impladent , Ltd.United StatesMakerOsteoTape / OsteoGen Plug / OsteoGen Strip102014
NIBEC Co LtdSouth KoreaMakerbone grafting material, animal source · Creos Xenogain · Creos Xenogain Collagen · Instradent Xenograft · +742015
Odontit S.A.ArgentinaMakerCevOss · CITAGENIX · Kalos Biomedical · Osseo Seal · +132014
DePuy Spine, Inc.United StatesMakerHEALOS Dental · HEALOS Dental Bone Graft Replacement22010
Dsm BiomedicalUnited StatesMakerDSM Dental Bone Graft · DSM Dental Bone Graft Plus12020
Chiyewon Co., Ltd.South KoreaMaker—12015
RTI Surgical, Inc. (dba RTI Biologics, Inc.)United StatesMaker———
Maxigen Biotech IncTaiwanMakerbone grafting material, animal source——
Dentsply Sirona, Inc.United StatesContract manufacturerOSSIX™ Bone1482026
Prismatik Dentalcraft, Inc.United StatesContract manufacturer—562026
Nobel Biocare Services AGSwitzerlandContract manufacturercreos942026
Young Innovations IncUnited StatesContract manufacturerFULFILL Socket Preservation Plug · SalvinOSS · SalvinOSS Collagen232025
Park Dental Research CorpUnited StatesContract manufacturerStarGraft Putty82026
Neoss ABSwedenForeign exporter—102022
Osteogenics Biomedical, Inc.United StatesContract manufacturerZCORE EXPAND Expandable Collagen-Enriched Porcine Xenograft · Zcore Porcine Xenograft Particulate · ZCORE porcine xenograft particulate IN SYRINGE52021
Bausch & Lomb IncorporatedUnited StatesManufacturer—31994
Sotera Health LLCUnited StatesContract manufacturerA-Graft BONE GRAFTING MATERIAL, ANIMAL SOURCE——
Sweden & Martina INCUnited StatesListerBone Grafting Material · BONE GRAFTING MATERIAL IN DELIVERY APPLICATOR · THE GRAFT——
STERIS CorporationUnited StatesContract sterilizer———
BBF Sterilisationsservice GmbHGermanyContract manufacturercerabone · Straumann cerabone——
IDOC Dental LabUnited StatesContract manufacturerBONE GRAFTING MATERIAL, ANIMAL SOURCE——
HANSAMED LIMITED dba CITAGENIXCanadaForeign exporterCevOss · PreservaRidge · The Graft · The Graft Collagen——
Epione BidcoFranceContract sterilizerBionnovation Oss XB · W-Bone · Wishbone HA——
Mediplast Israel Ltd.IsraelContract sterilizerOSSIX™ Bone——
Hudson Scientific LLCUnited StatesRepacker / relabelerOSSIX BONE——
Bausch Health US LLCUnited StatesLister———

510(k) clearances

Decided510(k)DeviceApplicant
9 Oct 2026K260096Wishbone HAEWishbone
25 Sep 2026K254210REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)HYUNDAI BIOLAND Co., Ltd.
16 Jun 2026K253723BOSSMEDPARK.Co., Ltd.
11 Jul 2025K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG
26 Jun 2025K251613SwissGraft XGeistlich Pharma AG
7 Mar 2025K242510Geistlich Bio-Flow®Geistlich Pharma AG
16 Aug 2024K240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC
24 Jul 2024K230305THE Graft CollagenPURGO BIOLOGICS Inc.
12 Jul 2024K240661Geistlich Bio-Oss®Geistlich Pharma AG
13 Oct 2023K231672S1MEDPARK.Co., Ltd.
18 Mar 2023K221808InterOss CollagenSigmaGraft, Inc.
20 Aug 2021K211551Wishbone HAWishbone
2 Apr 2021K202183Porcine Mineral Collagen CompositeCollagen Matrix, Inc.
11 Sep 2020K201859Porcine Mineral Collagen Composite MoldableCollagen Matrix, Inc.
10 Sep 2020K193212DSM Biomedical Dental Bone Graft PlusDsm Biomedical
14 Feb 2020K191737The Graft Bone SubstitutePURGO BIOLOGICS Inc.
19 Oct 2018K173594Straumann ceraboneInstitut Straumann AG
20 Jul 2018K173188The Graft Natural Bone SubstitutePURGO BIOLOGICS Inc.
30 Oct 2017K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc.
18 Jul 2017K163714OSSIX BONEDatum Dental, Ltd.
7 Jul 2017K170541Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.
16 May 2017K170245DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm Biomedical
9 Feb 2017K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.
3 Aug 2016K151542A-OssHiossen Inc.
10 Dec 2015K150079Regenomer® Syringe, Regenomer® Plug, Regenomer® BlockNIBEC Co Ltd
6 Nov 2015K151209InterOssSigmaGraft, Inc.
31 Jul 2015K142040OCS-B COLLAGENNIBEC Co Ltd
5 Jun 2015K140021TI-OSSChiyewon Co., Ltd.
16 Jul 2014K140714PORCINE ANORGANIC BONE MINERALCollagen Matrix, Inc.
22 May 2014K123876SYNERGYOdontit S.A.
15 Feb 2013K122894GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLICGeistlich Pharma AG
16 Jan 2013K113246OCS-BNIBEC Co Ltd
13 Aug 2012K120152CERASORB PLUSRiemser Arzneimittel AG
24 May 2012K120601GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OGeistlich Pharma AG
28 Dec 2011K112572GEISTLICH COMBI-KIT COLLEGENGeistlich Pharma AG
27 Dec 2011K112575GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIOGeistlich Pharma AG
29 Sep 2011K111816EQUIMATRIXLuitpold Pharmaceuticals, Inc.
18 Aug 2010K091424OSTA MAXIGRO AND REGIGROOsta Technologies
18 Mar 2010K092428BIO-OSS COLLAGENEd. Geistlich Soehne AG Fuer Chemische Industrie
10 Dec 2009K090794OSTEOTAPEImpladent , Ltd.
4 Aug 2005K043034OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTSCollagen Matrix, Inc.
15 Jan 2004K033815BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGENGeistlich Pharma AG

Official records: FDA product classification for NPM · 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