Home › Device types › NPM
Bone Grafting Material, Animal Source
FDA product code NPM · Class 2 · Dental
801
Registered devices
113
Adverse events
11
Recalls
42
510(k) clearances
Devices with this code
BoneMedik-DM, 0.3~0.5mm, 0.5g — Meta Biomed Co., Ltd.ZCORE — Osteogenics Biomedical IncNeodent XenoGraft — Nibec Co., Ltd.TI-OSS — CHIYEWON.LTDbioXEN — COLLAGEN MATRIX, INC.SynOss Putty — COLLAGEN MATRIX, INC.OUSIA bioXEN — ACE SURGICAL SUPPLY CO., INC.MatrixOss Granules — COLLAGEN MATRIX, INC.OUSIA bioXEN — ACE SURGICAL SUPPLY CO., INC.CevOss - CITAGENIX — ODONTIT S.A.Geistlich Bio-Oss® Flow — Geistlich Pharma AGTHE Graft — PURGO BIOLOGICS Inc.Straumann XenoFlex — Nibec Co., Ltd.Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THESwissGraft X D-Line — Geistlich Pharma AGDirectOss™ — IMPLANT DIRECT SYBRON MANUFACTURING LLCTHE Graft — PURGO BIOLOGICS Inc.OCS-B — Nibec Co., Ltd.cerabone® — botiss biomaterials GmbHOsteoGen Block — Impladent, Ltd.MinerOss XP — COLLAGEN MATRIX, INC.InterOss® — SIGMAGRAFT, INC.Maxxeus — FOUNDATION FOR COMMUNITY BLOOD CENTER/COMMUNITY TISSUE SERVICES, THENeoGenix XP — COLLAGEN MATRIX, 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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