Cleared Traditional

HG II FIXTURE SYSTEM

K090237 · Hiossen, Inc. · Dental
Apr 2009
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K090237 is an FDA 510(k) clearance for the HG II 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 April 17, 2009, 74 days after receiving the submission on February 2, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K090237 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2009
Decision Date April 17, 2009
Days to Decision 74 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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