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FDA 510(k)

DENTAPORT ZX

K-Number: K031204 · 2003-08-21

ApplicantJ. Morita USA, Inc.
Decision Date2003-08-21
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAPORT ZX is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2003-08-21 under 510(k) number K031204. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAPORT ZX?

DENTAPORT ZX is a medical device that received FDA 510(k) clearance on 2003-08-21. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K031204.

When did DENTAPORT ZX receive FDA 510(k) clearance?

DENTAPORT ZX received FDA 510(k) clearance on 2003-08-21, under 510(k) number K031204.

Who is the listed applicant for DENTAPORT ZX?

The FDA 510(k) record lists J. Morita USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAPORT ZX?

The FDA product code for DENTAPORT ZX is EKX.

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Other records listing J. Morita USA, Inc. as applicant

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Related Devices (Code: EKX)

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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