Cleared Traditional

ET II BIO-SA FIXTURE SYSTEM

K112532 · Hiossen, Inc. · Dental
Aug 2012
Decision
341d
Days
Class 2
Risk

About This 510(k) Submission

K112532 is an FDA 510(k) clearance for the ET II 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 August 6, 2012, 341 days after receiving the submission on August 31, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K112532 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2011
Decision Date August 06, 2012
Days to Decision 341 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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