510(k) K240133
- Device
- Xenograft Bovine Bone Particulate
- Applicant
- Collagen Solutions, LLC
- 510(k) number
- K240133
- Product code
- NPM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-16
- Date received
- 2024-01-18
- Regulation
- 872.3930
- Classification name
- Bone Grafting Material, Animal Source
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sheila Hunter
- Address
- 6455 City W. Pkwy. Eden Prairie MN US 55344 55344
FDA Registration Numbers#
- 3013820501
- 3013171899
- 3027448274
- 3009443653
- 8043792
- 3008729892
- 3015131160
- 1526439
- 3004884150
- 3010178296
- 3029731364
- 1066741
- 2219920
- 1650372
- 3004146122
- 3007321028
- 3013037032
- 3011649314
- 3031886796
- 1030489
- 1313525
- 3011802717
- 9614442
- 3006540014
- 3006017180
- 3007679154
- 3003300673
- 3017399129
- 3007135442
- 2245590
- 3008910197
- 3013934196
- 3004431266
- 3011824442
- 3014448321
- 2249852
- 3018094310
- 9680963
- 1319660
- 2530154
- 9613348
- 2431866
- 2245304
- 3011276344
- 3009598981
- 9681254
- 3014206569
Source Documents#
Other 510(k) Records For Product Code NPM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | 2025-07-11 |
| K251613 | SwissGraft X | Geistlich Pharma AG | 2025-06-26 |
| K242510 | Geistlich Bio-Flow® | Geistlich Pharma AG | 2025-03-07 |
| K230305 | THE Graft Collagen | Purgo Biologics, Inc. | 2024-07-24 |
| K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | 2024-07-12 |
| K231672 | S1 | Medpark Co., Ltd. | 2023-10-13 |
| K221808 | InterOss Collagen | Sigmagraft, Inc. | 2023-03-18 |
| K211551 | Wishbone HA | Wishbone SA | 2021-08-20 |
| K202183 | Porcine Mineral Collagen Composite | Collagen Matrix, Inc. | 2021-04-02 |
| K201859 | Porcine Mineral Collagen Composite Moldable | Collagen Matrix, Inc. | 2020-09-11 |
| K193212 | DSM Biomedical Dental Bone Graft Plus | Dsm Biomedical | 2020-09-10 |
| K191737 | The Graft Bone Substitute | Purgo Biologics, Inc. | 2020-02-14 |
| K173594 | Straumann cerabone | Institut Straumann AG | 2018-10-19 |
| K173188 | The Graft Natural Bone Substitute | Purgo Biologics, Inc. | 2018-07-20 |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | Collagen Matrix, Inc. | 2017-10-30 |