Cleared Traditional

K083586 - I-FIX SYSTEM

K083586 is an FDA 510(k) clearance for I-FIX SYSTEM, manufactured by Dentis Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K083586 · Dentis Co., Ltd. · Dental device
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Apr 2009
Decision
146d
Days
Class 2
Risk

K083586 is an FDA 510(k) clearance for the I-FIX SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentis Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 29, 2009 after a review of 146 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 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 Dentis Co., Ltd. devices

FDA 510(k) Submission Details - K083586

510(k) Number K083586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2008
Decision Date April 29, 2009
Days to Decision 146 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
19d slower than avg
Panel avg: 127d · This submission: 146d
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 1173
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K083586.
SINUS QUICK IT SYSTEM
K090527 · Neobiotech Co., Ltd. · Jul 2009
MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM
K082843 · Dentis Co., Ltd. · Jun 2009
HS II SHORT FIXTURE SYSTEM
K083633 · Osstem Implant Co., Ltd. · May 2009
HG II FIXTURE SYSTEM
K090237 · Hiossen, Inc. · Apr 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · Straumann USA · Feb 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K081419 · Institut Straumann AG · Feb 2009