Cleared Traditional

BONTREE PLUS

K251818 · Hudens Bio Co., Ltd. · Dental

Mar 2026

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K251818 is an FDA 510(k) clearance for the BONTREE PLUS, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Hudens Bio Co., Ltd. (Gwangju, KR). The FDA issued a Cleared decision on March 6, 2026, 266 days after receiving the submission on June 13, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K251818 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2025
Decision Date	March 06, 2026
Days to Decision	266 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.