# K190192: K3Pro Konus New Abutments and Implants

- Pathway: 510(k) (Traditional)
- Applicant: Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG
- Decided: Feb 10, 2020 after 371 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: 1 generation back to K160581 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160581: K3PRO Konus Additional Abutments and Implants, Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG (2017) Summary page 4.

## Indications for use
The K3Pro® Konus New Abutments and Implants are designed to be compatible with the K3Pro® Konus Dental Implant system and are for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement. Delayed loading is recommended. The Ø7, 8, and 9mm implants are intended only for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. All digitally designed abutments for use with K3Pro® New Abutments and Implants are intended to be sent to an Argon validated milling center for manufacture.

Source page: https://510kreport.com/device/K190192
Methodology: https://510kreport.com/methodology