Cleared Traditional

OssBuilder System

K181854 · Osstem Implant Co., Ltd. · Dental
May 2019
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K181854 is an FDA 510(k) clearance for the OssBuilder System, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on May 7, 2019, 300 days after receiving the submission on July 11, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K181854 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2018
Decision Date May 07, 2019
Days to Decision 300 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZL — Screw, Fixation, Intraosseous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4880

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