Cleared Abbreviated

OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050

K062834 · Genoss Co., Ltd. · Dental
Apr 2007
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K062834 is an FDA 510(k) clearance for the OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Genoss Co., Ltd. (Laguna Niguel, US). The FDA issued a Cleared decision on April 24, 2007, 215 days after receiving the submission on September 21, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K062834 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2006
Decision Date April 24, 2007
Days to Decision 215 days
Submission Type Abbreviated
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.