Cleared Abbreviated

K171126 - Implantium II

K171126 is an FDA 510(k) clearance for Implantium II, manufactured by Dentium Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 143-day FDA review.

K171126 · Dentium Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
143d
Days
Class 2
Risk

K171126 is an FDA 510(k) clearance for the Implantium II. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentium Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on September 7, 2017 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dentium Co., Ltd. devices

FDA 510(k) Submission Details - K171126

510(k) Number K171126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date September 07, 2017
Days to Decision 143 days
Submission Type Abbreviated
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
16d slower than avg
Panel avg: 127d · This submission: 143d
Pathway characteristics
Standards-based clearance path.

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

Denterprise International, Inc. / 510k FDA Consulting
Joyce St. Germain

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 793
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K171126.
BioHorizons Tapered Short Implants
K172576 · BioHorizons Implant Systems, Inc. · Nov 2017
TREFOIL System
K172352 · Nobel Biocare AB · Oct 2017
Thommen Implant System
K171795 · Thommen Medical AG · Sep 2017
Dentis Dental Implant System
K171027 · Dentis Co., Ltd. · Sep 2017
Neodent Implant System - GM Line
K163194 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jul 2017
MRI Compatibility for Existing Zimmer Dental Implant Systems
K160398 · Zimmer Dental, Inc. · May 2017