Device class
Class II
Regulation 872.3930
Total clearances
15
2020-02-14 → 2026-09-25
Definition
What is Bone Grafting Material, Animal Source
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
Classification details
Regulation number
872.3930
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Geistlich Pharma AG
|
4 |
0 |
2025-07-11 |
|
Collagen Matrix, Inc.
|
2 |
0 |
2021-04-02 |
|
Medpark Co., Ltd. |
2 |
1 |
2026-06-16 |
|
Purgo Biologics, Inc.
|
2 |
0 |
2024-07-24 |
|
Wishbone SA |
1 |
0 |
2021-08-20 |
|
Dsm Biomedical |
1 |
0 |
2020-09-10 |
|
Sigmagraft, Inc. |
1 |
0 |
2023-03-18 |
|
Hyundai Bioland Co., Ltd. |
1 |
1 |
2026-09-25 |
|
Collagen Solutions, LLC |
1 |
0 |
2024-08-16 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 21299 |
CPT
|
— |
Medium
|
Unlisted craniofacial and maxillofacial procedure; animal-source bone graft material application |
| D7992 |
CPT
|
— |
Medium
|
Dental-specific code for bone graft and/or bone substitute material when used with animal-source material |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-25 |
K254210 |
Hyundai Bioland Co., Ltd.
|
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) |
| 2026-06-16 |
K253723 |
Medpark Co., Ltd.
|
BOSS |
| 2025-07-11 |
K251786 |
Geistlich Pharma AG
|
Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® |
| 2025-06-26 |
K251613 |
Geistlich Pharma AG
|
SwissGraft X |
| 2025-03-07 |
K242510 |
Geistlich Pharma AG
|
Geistlich Bio-Flow® |
| 2024-08-16 |
K240133 |
Collagen Solutions, LLC
|
Xenograft Bovine Bone Particulate |
| 2024-07-24 |
K230305 |
Purgo Biologics, Inc.
|
THE Graft Collagen |
| 2024-07-12 |
K240661 |
Geistlich Pharma AG
|
Geistlich Bio-Oss® |
| 2023-10-13 |
K231672 |
Medpark Co., Ltd.
|
S1 |
| 2023-03-18 |
K221808 |
Sigmagraft, Inc.
|
InterOss Collagen |
| 2021-08-20 |
K211551 |
Wishbone SA
|
Wishbone HA |
| 2021-04-02 |
K202183 |
Collagen Matrix, Inc.
|
Porcine Mineral Collagen Composite |
| 2020-09-11 |
K201859 |
Collagen Matrix, Inc.
|
Porcine Mineral Collagen Composite Moldable |
| 2020-09-10 |
K193212 |
Dsm Biomedical
|
DSM Biomedical Dental Bone Graft Plus |
| 2020-02-14 |
K191737 |
Purgo Biologics, Inc.
|
The Graft Bone Substitute |