Cleared Traditional

SS SA Fixture

K163557 · Osstem Implant Co., Ltd. · Dental
May 2017
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K163557 is an FDA 510(k) clearance for the SS SA Fixture, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on May 15, 2017, 147 days after receiving the submission on December 19, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K163557 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2016
Decision Date May 15, 2017
Days to Decision 147 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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