Cleared Abbreviated

EM Provisional

K191751 · Hiossen, Inc. · Dental
Dec 2019
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K191751 is an FDA 510(k) clearance for the EM Provisional, 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 December 16, 2019, 168 days after receiving the submission on July 1, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K191751 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2019
Decision Date December 16, 2019
Days to Decision 168 days
Submission Type Abbreviated
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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