Cleared Traditional

HT III SA FIXTURE SYSTEM

K101096 · Hiossen, Inc. · Dental
Oct 2010
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K101096 is an FDA 510(k) clearance for the HT III 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 October 8, 2010, 171 days after receiving the submission on April 20, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K101096 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2010
Decision Date October 08, 2010
Days to Decision 171 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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