Cleared Traditional

EM SA Implant System

K191201 · Hiossen, Inc. · Dental
Nov 2019
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K191201 is an FDA 510(k) clearance for the EM SA Implant 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 November 15, 2019, 193 days after receiving the submission on May 6, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K191201 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2019
Decision Date November 15, 2019
Days to Decision 193 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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