Cleared Traditional

ET III Bio-SA Fixture System

K151626 · Hiossen, Inc. · Dental
Jul 2016
Decision
400d
Days
Class 2
Risk

About This 510(k) Submission

K151626 is an FDA 510(k) clearance for the ET III Bio-SA Fixture System, 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 July 21, 2016, 400 days after receiving the submission on June 17, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K151626 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2015
Decision Date July 21, 2016
Days to Decision 400 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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