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FDA 510(k)

Y-TZP POWDER AND PROCERA ALLZIRKON

K-Number: K010630 · 2001-04-17

ApplicantProcera Sandvik, Inc.
Decision Date2001-04-17
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Y-TZP POWDER AND PROCERA ALLZIRKON is the device name listed in this FDA 510(k) record. The listed applicant is Procera Sandvik, Inc.. It received FDA 510(k) clearance on 2001-04-17 under 510(k) number K010630. 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 Y-TZP POWDER AND PROCERA ALLZIRKON?

Y-TZP POWDER AND PROCERA ALLZIRKON is a medical device that received FDA 510(k) clearance on 2001-04-17. The listed applicant is Procera Sandvik, Inc.. The 510(k) number is K010630.

When did Y-TZP POWDER AND PROCERA ALLZIRKON receive FDA 510(k) clearance?

Y-TZP POWDER AND PROCERA ALLZIRKON received FDA 510(k) clearance on 2001-04-17, under 510(k) number K010630.

Who is the listed applicant for Y-TZP POWDER AND PROCERA ALLZIRKON?

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

What is the FDA product code for Y-TZP POWDER AND PROCERA ALLZIRKON?

The FDA product code for Y-TZP POWDER AND PROCERA ALLZIRKON is EIH.

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Other records listing Procera Sandvik, 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.

K001418ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S

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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