Cleared Traditional

K153521 - IH Implant System

K153521 is an FDA 510(k) clearance for IH Implant System, manufactured by Sewonmedix, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K153521 · Sewonmedix, Inc. · Dental device
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Oct 2016
Decision
311d
Days
Class 2
Risk

K153521 is an FDA 510(k) clearance for the IH Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sewonmedix, Inc. (Busan, KR). The FDA issued a Cleared decision on October 14, 2016 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sewonmedix, Inc. devices

FDA 510(k) Submission Details - K153521

510(k) Number K153521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2015
Decision Date October 14, 2016
Days to Decision 311 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 127d · This submission: 311d
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 767
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K153521.
s-Clean OneQ-SL Narrow Implant System
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OSSTEM Implant System
K161604 · Osstem Implant Co., Ltd. · Oct 2016
ET III Bio-SA Fixture System
K151626 · Hiossen, Inc. · Jul 2016
NR Line Implant System
K153268 · Dentium Co., Ltd. · Jul 2016
s-Clean Tapered II RBM Implant System
K160213 · Dentis Co., Ltd. · Jun 2016