LYC

Bone Grafting Material, Synthetic

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2026-07-06.

NumberDecision dateApplicantDevice nameSummary
K2533172026-07-06GC America, Inc.Cytrans™ ElashieldPDF
K2538832026-05-14Bonalive , Ltd.Bonalive MaxillofacialPDF
K2518182026-03-06Hudens Bio Co., Ltd.BONTREE PLUSPDF
K2440062025-09-17Full Golden Biotech Co., Ltd.FG Bone Graft MPDF
K2437452025-08-29Full Golden Biotech CorporationFG Bone Graft BPDF
K2411862025-02-21Shenzhen Dazhou Medical Technology Co.…Synthetic Bone Graft ParticulatePDF

6 summaries are archived here for direct download.

Official FDA classification page: LYC
Classification and pathway per current FDA publications. Data from openFDA (CC0).