Cleared Traditional

FG Bone Graft B

K243745 · Full Golden Biotech Corporation · Dental
Aug 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K243745 is an FDA 510(k) clearance for the FG Bone Graft B, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Full Golden Biotech Corporation (Taichung, TW). The FDA issued a Cleared decision on August 29, 2025, 267 days after receiving the submission on December 5, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K243745 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2024
Decision Date August 29, 2025
Days to Decision 267 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.