Cleared Special

ET III SA ULTRA WIDE SYSTEM

K103537 · Hiossen, Inc. · Dental
Mar 2011
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K103537 is an FDA 510(k) clearance for the ET III SA ULTRA WIDE 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 March 10, 2011, 98 days after receiving the submission on December 2, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K103537 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2010
Decision Date March 10, 2011
Days to Decision 98 days
Submission Type Special
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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