Cleared Traditional

K160060 - DMi Dental Implant System

K160060 is an FDA 510(k) clearance for DMi Dental Implant System, manufactured by Dmi Innovative Medical Technology , Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K160060 · Dmi Innovative Medical Technology , Ltd. · Dental device
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Oct 2016
Decision
265d
Days
Class 2
Risk

K160060 is an FDA 510(k) clearance for the DMi Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dmi Innovative Medical Technology , Ltd. (Holon, IL). The FDA issued a Cleared decision on October 3, 2016 after a review of 265 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.

FDA 510(k) Submission Details - K160060

510(k) Number K160060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2016
Decision Date October 03, 2016
Days to Decision 265 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 128d · This submission: 265d
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 Consultant

Duet Medical Consulting , Ltd.
Eilat Ezra

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K160060.
KJ Mini Implant System
K151970 · Kj Meditech Co., Ltd. · Oct 2016
OSSTEM Implant System
K161604 · Osstem Implant Co., Ltd. · Oct 2016
IH Implant System
K153521 · Sewonmedix, Inc. · Oct 2016
Implance Dental Implant System, Implance Dental Abutment System
K160221 · Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · Sep 2016
BBX1, BBX2, BBX1MO, BBX1MC
K142846 · Globaldental, Inc. · Sep 2016
LUNA DENTAL IMPLANT SYSTEM
K160106 · Shinhung Mst Co., Ltd. · Aug 2016