510(k) Report

FDA applicant

Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG

Bingen Am Rhein, DE4 decisions2015–20200 recalls

FDA records 4 decisions for Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG (Bingen Am Rhein, DE) from 2015 to 2020: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 371 days from receipt to decision, against 223 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Argon Med. Productions Vertriebs Gesellschaft Mbh”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015: 12016: 12017: 12020: 1
2015high 1 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form3decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 371 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 223 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160581K3PRO Konus Additional Abutments and ImplantsArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG · 20171cites it

What has FDA decided for it lately?

  • K190192K3Pro Konus New Abutments and ImplantsArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG · 2020
  • K160581K3PRO Konus Additional Abutments and ImplantsArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG · 2017
  • K160574K3PRO Surgical TrayArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG · 2016
  • K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh · 2015

All 3 as Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG →The one decision as Argon Med. Productions Vertriebs Gesellschaft Mbh →

Other applicant names beginning “Argon”

FDA records each applicant name separately; these may or may not be the same firm.

Argon Medical Corp. 28Argon Medical Devices, Inc. 25