Cleared Traditional

K191201 - EM SA Implant System

K191201 is an FDA 510(k) clearance for EM SA Implant System, manufactured by Hiossen, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 193-day FDA review.

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

K191201 is an FDA 510(k) clearance for the EM SA Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on November 15, 2019 after a review of 193 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Hiossen, Inc. devices

FDA 510(k) Submission Details - K191201

510(k) Number K191201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 127d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1182
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K191201.
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K190958 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Nov 2019
W Zirconia Implants
K192053 · Tav Medical , Ltd. · Oct 2019