LYC
- Product code
- LYC
- Device name
- Bone Grafting Material, Synthetic
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3930
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 231 (all years; only the last 3 years are listed here)
FDA classification definition
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.
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253317 | 2026-07-06 | GC America, Inc. | Cytrans Elashield | |
| K253883 | 2026-05-14 | Bonalive , Ltd. | Bonalive Maxillofacial | |
| K251818 | 2026-03-06 | Hudens Bio Co., Ltd. | BONTREE PLUS | |
| K244006 | 2025-09-17 | Full Golden Biotech Co., Ltd. | FG Bone Graft M | |
| K243745 | 2025-08-29 | Full Golden Biotech Corporation | FG Bone Graft B | |
| K241186 | 2025-02-21 | Shenzhen Dazhou Medical Technology Co.… | Synthetic Bone Graft Particulate |
Official FDA classification page: LYC
Classification and pathway per current FDA publications. Data from openFDA (CC0).