Cleared Traditional

K141159 - KONUS DENTAL IMPLANT SYSTEM

K141159 is an FDA 510(k) clearance for KONUS DENTAL IMPLANT SYSTEM, manufactured by Argon Med. Productions Vertriebs Gesellschaft Mbh. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K141159 · Argon Med. Productions Vertriebs Gesellschaft Mbh · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
310d
Days
Class 2
Risk

K141159 is an FDA 510(k) clearance for the KONUS DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Argon Med. Productions Vertriebs Gesellschaft Mbh (Marshfield, US). The FDA issued a Cleared decision on March 11, 2015 after a review of 310 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.

FDA 510(k) Submission Details - K141159

510(k) Number K141159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2014
Decision Date March 11, 2015
Days to Decision 310 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
182d slower than avg
Panel avg: 128d · This submission: 310d
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 1521
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K141159.
EBI External Implant System
K142426 · Ebi, Inc. · Mar 2015
IBS IMPLANT SYSTEM
K140806 · Innobiosurg Co., Ltd. · Mar 2015
BIOMATE DENTAL IMPLANT SYSTEM
K142174 · Biomate Medical Devices Technology Co., Ltd. · Mar 2015
PREMIUM, SHELTA Implant Systems
K142242 · Sweden & Martina S.P.A. · Feb 2015
WINSIX Implant System
K133733 · Biosaf IN S.R.L. · Jan 2015
BioHorizons Tapered Internal Implants
K143022 · BioHorizons Implant Systems, Inc. · Jan 2015
K141159 · KONUS DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Argon Med. Production…