# K141159: Konus Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Argon Med. Productions Vertriebs Gesellschaft Mbh
- Decided: Mar 11, 2015 after 310 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K960026 (1996). 144 ancestors in all.
No later device cites it as a predicate yet.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 4.
- K102822: Implant-One System, Custom Dental Implants, Inc. (2011) Summary page 4.
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems, Dentsply International, Inc. (2008) Summary page 4.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 4.
- K133884: Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MM, Biodenta Swiss AG (2014). Cleared while this submission was under review Summary page 4.

## Indications for use
The Konus K3Pro and K3Pro Rapid Implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement.

Source page: https://510kreport.com/device/K141159
Methodology: https://510kreport.com/methodology