Device class
Class II
Regulation 872.3930
Total clearances
11
2020-08-17 → 2026-07-06
Definition
What is Bone Grafting Material, Synthetic
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal 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 |
|
Full Golden Biotech Corporation |
2 |
2 |
2025-09-17 |
|
GC America, Inc.
|
2 |
1 |
2026-07-06 |
|
Osteogene Tech Corp |
1 |
0 |
2022-03-04 |
|
Dimension Inx Corp. |
1 |
0 |
2022-12-30 |
|
Institut Straumann AG
|
1 |
0 |
2020-09-24 |
|
Revisios BV |
1 |
0 |
2020-10-02 |
|
Bonalive , Ltd. |
1 |
1 |
2026-05-14 |
|
Shenzhen Dazhou Medical Technology Co., Ltd. |
1 |
0 |
2025-02-21 |
|
Hudens Bio Co., Ltd. |
1 |
1 |
2026-03-06 |
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 |
| D7995 |
CPT
|
— |
High
|
CPT code for bone graft or bone graft substitute, implantation; first tooth, implant, or edentulous tooth position in graft |
| D7996 |
CPT
|
— |
High
|
CPT code for bone graft or bone graft substitute, implantation; each additional contiguous tooth, implant or edentulous tooth position in same graft site |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-07-06 |
K253317 |
GC America, Inc.
|
Cytrans Elashield |
| 2026-05-14 |
K253883 |
Bonalive , Ltd.
|
Bonalive Maxillofacial |
| 2026-03-06 |
K251818 |
Hudens Bio Co., Ltd.
|
BONTREE PLUS |
| 2025-09-17 |
K244006 |
Full Golden Biotech Co., Ltd.
|
FG Bone Graft M |
| 2025-08-29 |
K243745 |
Full Golden Biotech Corporation
|
FG Bone Graft B |
| 2025-02-21 |
K241186 |
Shenzhen Dazhou Medical Technology Co., Ltd.
|
Synthetic Bone Graft Particulate |
| 2022-12-30 |
K213260 |
Dimension Inx Corp.
|
CMFlexTM |
| 2022-03-04 |
K202675 |
Osteogene Tech Corp
|
InRoad® Dental Synthetic Bone Graft |
| 2020-10-02 |
K201546 |
Revisios BV
|
OsOpia Synthetic Bone Void Filler |
| 2020-09-24 |
K201051 |
Institut Straumann AG
|
Straumann BoneCeramic |
| 2020-08-17 |
K192597 |
GC America, Inc.
|
Cytrans Granules |