Cleared Traditional

ETII SA FIXTURE SYSTEM

K123471 · Hiossen, Inc. · Dental
Jul 2013
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K123471 is an FDA 510(k) clearance for the ETII 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 5, 2013, 234 days after receiving the submission on November 13, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K123471 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2012
Decision Date July 05, 2013
Days to Decision 234 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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