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FDA 510(k)

ArgenZ MTZ

K-Number: K242458 · 2024-10-24

ApplicantArgen Corporation
Decision Date2024-10-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ArgenZ MTZ is the device name listed in this FDA 510(k) record. The listed applicant is Argen Corporation. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K242458. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArgenZ MTZ?

ArgenZ MTZ is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Argen Corporation. The 510(k) number is K242458.

When did ArgenZ MTZ receive FDA 510(k) clearance?

ArgenZ MTZ received FDA 510(k) clearance on 2024-10-24, under 510(k) number K242458.

Who is the listed applicant for ArgenZ MTZ?

The FDA 510(k) record lists Argen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArgenZ MTZ?

The FDA product code for ArgenZ MTZ is EIH.

Other records listing Argen Corporation 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.

K192846Argen Clear Aligner, Argen Clear Aligner PremiumK183229Argen Clear AlignerK172430ArgenIS Titanium AbutmentsK160248ArgenIS Titanium Abutments

Related Devices (Code: EIH)

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.

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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.

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