Cleared Traditional

ETIII SA Fixture System (O3.2mm)

K153332 · Hiossen, Inc. · Dental
Oct 2016
Decision
343d
Days
Class 2
Risk

About This 510(k) Submission

K153332 is an FDA 510(k) clearance for the ETIII SA Fixture System (O3.2mm), a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on October 27, 2016, 343 days after receiving the submission on November 19, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K153332 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2015
Decision Date October 27, 2016
Days to Decision 343 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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