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FDA 510(k)

SUPER PORCELAIN STAIN- PURE WHITE

K-Number: K983470 · 1998-12-22

ApplicantNoritake Co., Inc.
Decision Date1998-12-22
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPER PORCELAIN STAIN- PURE WHITE 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 1998-12-22 under 510(k) number K983470. 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 STAIN- PURE WHITE?

SUPER PORCELAIN STAIN- PURE WHITE is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Noritake Co., Inc.. The 510(k) number is K983470.

When did SUPER PORCELAIN STAIN- PURE WHITE receive FDA 510(k) clearance?

SUPER PORCELAIN STAIN- PURE WHITE received FDA 510(k) clearance on 1998-12-22, under 510(k) number K983470.

Who is the listed applicant for SUPER PORCELAIN STAIN- PURE WHITE?

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 STAIN- PURE WHITE?

The FDA product code for SUPER PORCELAIN STAIN- PURE WHITE 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.

K111383ZIRPRIMEK111107SUPER PORCELAIN EX-3 UNIVERSAL OPAQUEK052304SUPER PORCELAIN EX-3 PRESSK050920CZR PRESS LF STAINSK050160KATANA ZIRCONIAK043462CZR PRESS LF

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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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