Cleared Traditional

OssBuilder System

K172354 · Osstem Implant Co., Ltd. · Dental
Mar 2018
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K172354 is an FDA 510(k) clearance for the OssBuilder System, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on March 26, 2018, 235 days after receiving the submission on August 3, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K172354 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2017
Decision Date March 26, 2018
Days to Decision 235 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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