FDA Product Code
FDA Product Code NPM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3930
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254210 | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | Hyundai Bioland Co., Ltd. | 2026-09-25 | Traditional | PDF ↗ |
| K253723 | BOSS | Medpark Co., Ltd. | 2026-06-16 | Traditional | PDF ↗ |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | 2025-07-11 | Special | PDF ↗ |
| K251613 | SwissGraft X | Geistlich Pharma AG | 2025-06-26 | Special | PDF ↗ |
| K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | 2025-03-07 | Traditional | PDF ↗ |
| K240133 | Xenograft Bovine Bone Particulate | Collagen Solutions, LLC | 2024-08-16 | Traditional | PDF ↗ |
| K230305 | THE Graft Collagen | Purgo Biologics, Inc. | 2024-07-24 | Traditional | PDF ↗ |
| K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | 2024-07-12 | Traditional | PDF ↗ |
| K231672 | S1 | Medpark Co., Ltd. | 2023-10-13 | Traditional | PDF ↗ |
| K221808 | InterOss Collagen | Sigmagraft, Inc. | 2023-03-18 | Traditional | PDF ↗ |
| K211551 | Wishbone HA | Wishbone SA | 2021-08-20 | Traditional | PDF ↗ |
| K202183 | Porcine Mineral Collagen Composite | Collagen Matrix, Inc. | 2021-04-02 | Traditional | PDF ↗ |
| K201859 | Porcine Mineral Collagen Composite Moldable | Collagen Matrix, Inc. | 2020-09-11 | Traditional | PDF ↗ |
| K193212 | DSM Biomedical Dental Bone Graft Plus | Dsm Biomedical | 2020-09-10 | Traditional | PDF ↗ |
| K191737 | The Graft Bone Substitute | Purgo Biologics, Inc. | 2020-02-14 | Traditional | PDF ↗ |
| K173594 | Straumann cerabone | Institut Straumann AG | 2018-10-19 | Traditional | PDF ↗ |
| K173188 | The Graft Natural Bone Substitute | Purgo Biologics, Inc. | 2018-07-20 | Abbreviated | PDF ↗ |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | Collagen Matrix, Inc. | 2017-10-30 | Traditional | PDF ↗ |
| K163714 | OSSIX BONE | Datum Dental, Ltd. | 2017-07-18 | Traditional | PDF ↗ |
| K170541 | Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | 2017-07-07 | Traditional | PDF ↗ |
| K170245 | DSM Biomedical Dental Bone Graft | Kensey Nash Corporation Dba Dsm Biomedical | 2017-05-16 | Traditional | PDF ↗ |
| K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | 2017-02-09 | Traditional | PDF ↗ |
| K151542 | A-Oss | Hiossen, Inc. | 2016-08-03 | Traditional | PDF ↗ |
| K150079 | Regenomer® Syringe, Regenomer® Plug, Regenomer® Block | Nibec Co., Ltd. | 2015-12-10 | Abbreviated | PDF ↗ |
| K151209 | InterOss | Sigmagraft, Inc. | 2015-11-06 | Traditional | PDF ↗ |
| K142040 | OCS-B COLLAGEN | Nibec Co., Ltd. | 2015-07-31 | Traditional | PDF ↗ |
| K140021 | TI-OSS | Chiyewon | 2015-06-05 | Traditional | PDF ↗ |
| K140714 | PORCINE ANORGANIC BONE MINERAL | Collagen Matrix, Inc. | 2014-07-16 | Traditional | PDF ↗ |
| K123876 | SYNERGY | Odontit S.A. | 2014-05-22 | Traditional | PDF ↗ |
| K122894 | GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC | Geistlich Pharma AG | 2013-02-15 | Traditional | PDF ↗ |
| K113246 | OCS-B | Nibec Company, Limited | 2013-01-16 | Traditional | PDF ↗ |
| K120152 | CERASORB PLUS | Riemser Arzneimittel AG | 2012-08-13 | Abbreviated | PDF ↗ |
| 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 | 2012-05-24 | Traditional | PDF ↗ |
| K112572 | GEISTLICH COMBI-KIT COLLEGEN | Geistlich Pharma AG | 2011-12-28 | Traditional | PDF ↗ |
| K112575 | GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO | Geistlich Pharma AG | 2011-12-27 | Traditional | PDF ↗ |
| K111816 | EQUIMATRIX | Luitpold Pharmaceuticals, Inc. | 2011-09-29 | Abbreviated | PDF ↗ |
| K091424 | OSTA MAXIGRO AND REGIGRO | Osta Technologies | 2010-08-18 | Abbreviated | PDF ↗ |
| K092428 | BIO-OSS COLLAGEN | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2010-03-18 | Traditional | PDF ↗ |
| K090794 | OSTEOTAPE | Impladent , Ltd. | 2009-12-10 | Traditional | PDF ↗ |
| K043034 | OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS | Collagen Matrix, Inc. | 2005-08-04 | Traditional | PDF ↗ |
| K033815 | BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN | Geistlich-Pharma | 2004-01-15 | Traditional | PDF ↗ |
Product code NPM · Class II · Dental. Data: openFDA.