Cleared Traditional

OSTEON III

K153676 · Genoss Co., Ltd. · Dental
Sep 2016
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K153676 is an FDA 510(k) clearance for the OSTEON III, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Genoss Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on September 14, 2016, 268 days after receiving the submission on December 21, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K153676 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2015
Decision Date September 14, 2016
Days to Decision 268 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.