Cleared Traditional

K3

K183347 · Osstem Implant Co., Ltd. · Dental
Sep 2019
Decision
275d
Days
Class 1
Risk

About This 510(k) Submission

K183347 is an FDA 510(k) clearance for the K3, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Osstem Implant Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 4, 2019, 275 days after receiving the submission on December 3, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K183347 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2018
Decision Date September 04, 2019
Days to Decision 275 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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