Cleared Traditional

TSIII BA Fixture

K163088 · Osstem Implant Co., Ltd. · Dental
Apr 2017
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K163088 is an FDA 510(k) clearance for the TSIII BA 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 April 21, 2017, 168 days after receiving the submission on November 4, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K163088 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2016
Decision Date April 21, 2017
Days to Decision 168 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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