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FDA 510(k)

K3Pro Konus New Abutments and Implants

K-Number: K190192 · 2020-02-10

ApplicantArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG
Decision Date2020-02-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K3Pro Konus New 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 2020-02-10 under 510(k) number K190192. 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 New Abutments and Implants?

K3Pro Konus New Abutments and Implants is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. The 510(k) number is K190192.

When did K3Pro Konus New Abutments and Implants receive FDA 510(k) clearance?

K3Pro Konus New Abutments and Implants received FDA 510(k) clearance on 2020-02-10, under 510(k) number K190192.

Who is the listed applicant for K3Pro Konus New 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 New Abutments and Implants?

The FDA product code for K3Pro Konus New Abutments and Implants is DZE.

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

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Official Source

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