Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

K3PRO Konus Additional Abutments and Implants

K-Number: K160581 · 2017-03-24

Decision Date2017-03-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K3PRO Konus Additional Abutments and Implants is the device name listed in this FDA 510(k) record. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K160581. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K3PRO Konus Additional Abutments and Implants?

K3PRO Konus Additional Abutments and Implants is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. The 510(k) number is K160581.

When did K3PRO Konus Additional Abutments and Implants receive FDA 510(k) clearance?

K3PRO Konus Additional Abutments and Implants received FDA 510(k) clearance on 2017-03-24, under 510(k) number K160581.

Who is the listed applicant for K3PRO Konus Additional Abutments and Implants?

The FDA 510(k) record lists Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K3PRO Konus Additional Abutments and Implants?

The FDA product code for K3PRO Konus Additional Abutments and Implants is DZE.

Other records listing Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.