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FDA 510(k)

A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06

K-Number: K100145 · 2010-04-13

ApplicantA&E Bioceramic Co., Ltd.
Decision Date2010-04-13
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 is the device name listed in this FDA 510(k) record. The listed applicant is A&E Bioceramic Co., Ltd.. It received FDA 510(k) clearance on 2010-04-13 under 510(k) number K100145. 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 A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06?

A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 is a medical device that received FDA 510(k) clearance on 2010-04-13. The listed applicant is A&E Bioceramic Co., Ltd.. The 510(k) number is K100145.

When did A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 receive FDA 510(k) clearance?

A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 received FDA 510(k) clearance on 2010-04-13, under 510(k) number K100145.

Who is the listed applicant for A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06?

The FDA 510(k) record lists A&E Bioceramic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06?

The FDA product code for A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 is EIH.

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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

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

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