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FDA 510(k)

BISQUE ZIRCONIA BLANKS, TYPE BYZ

K-Number: K081850 · 2008-09-25

ApplicantZircar Zirconia, Inc.
Decision Date2008-09-25
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISQUE ZIRCONIA BLANKS, TYPE BYZ is the device name listed in this FDA 510(k) record. The listed applicant is Zircar Zirconia, Inc.. It received FDA 510(k) clearance on 2008-09-25 under 510(k) number K081850. 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 BISQUE ZIRCONIA BLANKS, TYPE BYZ?

BISQUE ZIRCONIA BLANKS, TYPE BYZ is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is Zircar Zirconia, Inc.. The 510(k) number is K081850.

When did BISQUE ZIRCONIA BLANKS, TYPE BYZ receive FDA 510(k) clearance?

BISQUE ZIRCONIA BLANKS, TYPE BYZ received FDA 510(k) clearance on 2008-09-25, under 510(k) number K081850.

Who is the listed applicant for BISQUE ZIRCONIA BLANKS, TYPE BYZ?

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

What is the FDA product code for BISQUE ZIRCONIA BLANKS, TYPE BYZ?

The FDA product code for BISQUE ZIRCONIA BLANKS, TYPE BYZ is EIH.

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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.

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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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