Bone Grafting Material, Animal Source
Regulation 872.3930
3510(k)s in 12 months (42 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in NPM
| Company | 510(k)s | Recalls |
|---|---|---|
| Collagen Matrix, Inc. | 7 | 4 |
| Geistlich Pharma AG | 9 | 0 |
| Geistlich Pharma North America, Inc. | 0 | 6 |
| Nibec Co., Ltd. | 3 | 0 |
| Purgo Biologics, Inc. | 3 | 0 |
| Medpark Co., Ltd. | 2 | 0 |
| Sigmagraft, Inc. | 2 | 0 |
| Wishbone SA | 2 | 0 |
| Ace Surgical Supply Co., Inc. | 0 | 1 |
| Chiyewon | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K260096 | Wishbone HAE Wishbone SA, BE | NPM |
| Sep 25, 2026 | K254210 | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) Hyundai Bioland Co., Ltd., KR | NPM |
| Jun 16, 2026 | K253723 | BOSS Medpark Co., Ltd., KR | NPM |
| Jul 11, 2025 | K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® Geistlich Pharma AG, CH | NPM |
| Jun 26, 2025 | K251613 | SwissGraft X Geistlich Pharma AG, CH | NPM |
| Mar 7, 2025 | K242510 | Geistlich Bio-Flow® Geistlich Pharma AG, CH | NPM |
| Aug 16, 2024 | K240133 | Xenograft Bovine Bone Particulate Collagen Solutions, LLC | NPM |
| Jul 24, 2024 | K230305 | THE Graft Collagen Purgo Biologics, Inc., KR | NPM |
| Jul 12, 2024 | K240661 | Geistlich Bio-Oss® Geistlich Pharma AG, CH | NPM |
| Oct 13, 2023 | K231672 | S1 Medpark Co., Ltd., KR | NPM |
| Mar 18, 2023 | K221808 | InterOss Collagen Sigmagraft, Inc. | NPM |
| Aug 20, 2021 | K211551 | Wishbone HA Wishbone SA, BE | NPM |
| Apr 2, 2021 | K202183 | Porcine Mineral Collagen Composite Collagen Matrix, Inc. | NPM |
| Sep 11, 2020 | K201859 | Porcine Mineral Collagen Composite Moldable Collagen Matrix, Inc. | NPM |
| Sep 10, 2020 | K193212 | DSM Biomedical Dental Bone Graft Plus Dsm Biomedical | NPM |
| Feb 14, 2020 | K191737 | The Graft Bone Substitute Purgo Biologics, Inc., KR | NPM |
| Oct 19, 2018 | K173594 | Straumann cerabone Institut Straumann AG, CH | NPM |
| Jul 20, 2018 | K173188 | The Graft Natural Bone Substitute Purgo Biologics, Inc., KR | NPM |
| Oct 30, 2017 | K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator Collagen Matrix, Inc. | NPM |
| Jul 18, 2017 | K163714 | OSSIX BONE Datum Dental, Ltd., IL | NPM |
| Jul 7, 2017 | K170541 | Anorganic Bone Mineral in Delivery Applicator Collagen Matrix, Inc. | NPM |
| May 16, 2017 | K170245 | DSM Biomedical Dental Bone Graft Kensey Nash Corporation Dba Dsm Biomedical | NPM |
| Feb 9, 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator Collagen Matrix, Inc. | NPM |
| Aug 3, 2016 | K151542 | A-Oss Hiossen, Inc. | NPM |
| Dec 10, 2015 | K150079 | Regenomer® Syringe, Regenomer® Plug, Regenomer® Block Nibec Co., Ltd., KR | NPM |
| Nov 6, 2015 | K151209 | InterOss Sigmagraft, Inc. | NPM |
| Jul 31, 2015 | K142040 | OCS-B COLLAGEN Nibec Co., Ltd. | NPM |
| Jun 5, 2015 | K140021 | TI-OSS Chiyewon | NPM |
| Jul 16, 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL Collagen Matrix, Inc. | NPM |
| May 22, 2014 | K123876 | SYNERGY Odontit S.A. | NPM |
| Feb 15, 2013 | K122894 | GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC Geistlich Pharma AG | NPM |
| Jan 16, 2013 | K113246 | OCS-B Nibec Company, Limited | NPM |
| Aug 13, 2012 | K120152 | CERASORB PLUS Riemser Arzneimittel AG | NPM |
| May 24, 2012 | K120601 | GEISTLICH 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-O Geistlich Pharma AG | NPM |
| Dec 28, 2011 | K112572 | GEISTLICH COMBI-KIT COLLEGEN Geistlich Pharma AG | NPM |
| Dec 27, 2011 | K112575 | GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO Geistlich Pharma AG | NPM |
| Sep 29, 2011 | K111816 | EQUIMATRIX Luitpold Pharmaceuticals, Inc. | NPM |
| Aug 18, 2010 | K091424 | OSTA MAXIGRO AND REGIGRO Osta Technologies | NPM |
| Mar 18, 2010 | K092428 | BIO-OSS COLLAGEN Ed. Geistlich Soehne AG Fuer Chemische Industrie | NPM |
| Dec 10, 2009 | K090794 | OSTEOTAPE Impladent , Ltd. | NPM |
| Aug 4, 2005 | K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS Collagen Matrix, Inc. | NPM |
| Jan 15, 2004 | K033815 | BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN Geistlich-Pharma | NPM |
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