Cleared Traditional

FG Bone Graft M

K244006 · Full Golden Biotech Co., Ltd. · Dental
Sep 2025
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K244006 is an FDA 510(k) clearance for the FG Bone Graft M, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Full Golden Biotech Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on September 17, 2025, 265 days after receiving the submission on December 26, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K244006 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2024
Decision Date September 17, 2025
Days to Decision 265 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LYC — Bone Grafting Material, Synthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3930
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.