Home › Device types › NPM
Bone Grafting Material, Animal Source
FDA product code NPM · Class 2 · Dental
785
Registered devices
113
Adverse events
11
Recalls
40
510(k) clearances
Devices with this code
PuraXen+ — SIGMAGRAFT, INC.Straumann Regenomer — Nibec Co., Ltd.DSM Biomedical Dental Bone Graft — DSM BIOMEDICAL, INC.THE Graft — PURGO BIOLOGICS Inc.SCIOGRAFT — ODONTIT S.A.OCS-B — Nibec Co., Ltd.Newport Biologics Bone Graft Putty Mineral Collagen Composite — Prismatik Dentalcraft, Inccreos xenogain — Nibec Co., Ltd.Salvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLCSYMBIOS — COLLAGEN MATRIX, INC.MinerOss X — ACE SURGICAL SUPPLY CO., INC.SMARTGRAFT Syringe — COLLAGEN MATRIX, INC.OUSIA bioXEN — ACE SURGICAL SUPPLY CO., INC.S1 — MedPark co.,Ltd.NuOss — ACE SURGICAL SUPPLY CO., INC.Hexagon — ACE SURGICAL SUPPLY CO., INC.OCTABONE — CHIYEWON.LTDBoneMedik-DM, 2~4mm, 5cc — Meta Biomed Co., Ltd.THE Graft — PURGO BIOLOGICS Inc.RCM6 Resorbable Collagen Membrane, RCP, NuOss, Conform — ACE SURGICAL SUPPLY CO., INC.GIBSON HEALTHCARE — BENCO DENTAL SUPPLY CO.MinerOss® X — ACE SURGICAL SUPPLY CO., INC.cerabone® — botiss biomaterials GmbHZCORE FORM — Osteogenics Biomedical Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-02 | Ace Surgical Supply Co., Inc. | NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair |
| 2020-10-19 | Geistlich Pharma North America, Inc. | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding ti |
| 2020-10-19 | Geistlich Pharma North America, Inc. | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding ti |
| 2020-10-19 | Geistlich Pharma North America, Inc. | Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding ti |
| 2019-04-12 | Geistlich Pharma North America, Inc. | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| 2019-04-12 | Geistlich Pharma North America, Inc. | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| 2019-04-12 | Geistlich Pharma North America, Inc. | When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. |
| 2018-10-30 | Collagen Matrix Inc | There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled. |
| 2015-11-17 | Collagen Matrix Inc | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine. |
| 2015-08-25 | Collagen Matrix Inc | On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size |
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