Cleared Traditional

K190192 - K3Pro Konus New Abutments and Implants

K190192 is an FDA 510(k) clearance for K3Pro Konus New Abutments and Implants, manufactured by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K190192 · Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
371d
Days
Class 2
Risk

K190192 is an FDA 510(k) clearance for the K3Pro Konus New Abutments and Implants. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG (Bingen Am Rhein, DE). The FDA issued a Cleared decision on February 10, 2020 after a review of 371 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 Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG devices

FDA 510(k) Submission Details - K190192

510(k) Number K190192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2019
Decision Date February 10, 2020
Days to Decision 371 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
244d slower than avg
Panel avg: 127d · This submission: 371d
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

Argon Dental USA, LLC
Celline Lakus

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 766
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