Cleared Traditional

K160581 - K3PRO Konus Additional Abutments and Im...

K160581 is an FDA 510(k) clearance for K3PRO Konus Additional Abutments and Im..., 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 388-day FDA review.

K160581 · Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
388d
Days
Class 2
Risk

K160581 is an FDA 510(k) clearance for the K3PRO Konus Additional 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 March 24, 2017 after a review of 388 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 - K160581

510(k) Number K160581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2016
Decision Date March 24, 2017
Days to Decision 388 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 127d · This submission: 388d
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 767
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K160581.
TREFOIL System
K170135 · Nobel Biocare AB · May 2017
OneQ-SL s-Clean Implant System
K170220 · Dentis Co., Ltd. · Apr 2017
TSIII BA Fixture
K163088 · Osstem Implant Co., Ltd. · Apr 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
K162890 · Straumann USA, LLC · Mar 2017
US SA Implant System
K161103 · Osstem Implant Co., Ltd. · Feb 2017