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FDA 510(k)

Noritake Super Porcelain EX-3

K-Number: K193060 · 2020-01-30

ApplicantKuraray Noritake Dental, Inc.
Decision Date2020-01-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Noritake Super Porcelain EX-3 is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K193060. 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 Noritake Super Porcelain EX-3?

Noritake Super Porcelain EX-3 is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Kuraray Noritake Dental, Inc.. The 510(k) number is K193060.

When did Noritake Super Porcelain EX-3 receive FDA 510(k) clearance?

Noritake Super Porcelain EX-3 received FDA 510(k) clearance on 2020-01-30, under 510(k) number K193060.

Who is the listed applicant for Noritake Super Porcelain EX-3?

The FDA 510(k) record lists Kuraray Noritake Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Noritake Super Porcelain EX-3?

The FDA product code for Noritake Super Porcelain EX-3 is EIH.

Other records listing Kuraray Noritake Dental, Inc. as applicant

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Related Devices (Code: EIH)

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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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