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FDA 510(k)

Noritake Super Porcelain EX-3

K-Number: K193060 · 2020-01-30

Decision Date2020-01-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Noritake Super Porcelain EX-3 is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2020-01-30 under approval 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. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K193060.

When was Noritake Super Porcelain EX-3 approved by the FDA?

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

What company makes Noritake Super Porcelain EX-3?

Noritake Super Porcelain EX-3 is manufactured by Kuraray Noritake Dental, Inc..

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 Devices by Kuraray Noritake Dental, Inc.

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Official Source

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