Cleared Traditional

K191201 - EM SA Implant System

K191201 is the FDA 510(k) clearance for EM SA Implant System by Hiossen, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K191201.
Straumann Mini Implants
K191895 · Institut Straumann AG · Dec 2019
JJ Implant System
K190552 · Jj Implants · Dec 2019
SDS1.2 dental implant
K181953 · Sds Swiss Dental Solutions AG · Nov 2019
ST Internal Implant System
K192347 · Megagen Implant Co., Ltd. · Nov 2019
Neodent Implant System
K190958 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Nov 2019
W Zirconia Implants
K192053 · Tav Medical , Ltd. · Oct 2019