510(k) · Cleared
ClearedK3Pro Konus New Abutments and Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG · DZE Implant, Endosseous, Root-Form
Cleared on Feb 10, 2020 as substantially equivalent to K160581 (Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG, 2017) after a 371-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Feb 10, 2020
- Review
- 371 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K160581 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backK160581 K3PRO Konus Additional Abutments and ImplantsArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG · 2017
- This deviceK190192 K3Pro Konus New Abutments and ImplantsArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K160581 | K3PRO Konus Additional Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | 2017 | — |
| 0 (this device) | K190192 | K3Pro Konus New Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | 2020 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160581 | K3PRO Konus Additional Abutments and ImplantsSummary page 4…Codes The purpose of this submission is to expand the Argon Medical K3Pro® Konus Dental Implant System components cleared under K141159 and K160581. As such, this submission includes new implant bodies and Purpose additional abutments for previously cleared K3Pro® Impla… | 2017 |
| † | K071161 | Endosseous Dental Implant System | 2007 |
| † | K183138 | Certain BellaTek Express and BellaTek Flex Abutments | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
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…
Read the full statement (137 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190192: K3Pro Konus New Abutments and Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190192
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026