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FDA 510(k)

SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE

K-Number: K111107 · 2011-06-30

ApplicantNoritake Co., Inc.
Decision Date2011-06-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE is the device name listed in this FDA 510(k) record. The listed applicant is Noritake Co., Inc.. It received FDA 510(k) clearance on 2011-06-30 under 510(k) number K111107. 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 SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE?

SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE is a medical device that received FDA 510(k) clearance on 2011-06-30. The listed applicant is Noritake Co., Inc.. The 510(k) number is K111107.

When did SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE receive FDA 510(k) clearance?

SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE received FDA 510(k) clearance on 2011-06-30, under 510(k) number K111107.

Who is the listed applicant for SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE?

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

What is the FDA product code for SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE?

The FDA product code for SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE is EIH.

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Other records listing Noritake Co., Inc. 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.

K111383ZIRPRIMEK052304SUPER PORCELAIN EX-3 PRESSK050920CZR PRESS LF STAINSK050160KATANA ZIRCONIAK043462CZR PRESS LFK031968CERABIEN ZR

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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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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