FDA 510(k)

Purzir Dental Zirconia

K-Number: K193055 · 2020-05-13

Decision Date2020-05-13

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Purzir Dental Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is 3DBiocad. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K193055. 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 Purzir Dental Zirconia?

Purzir Dental Zirconia is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is 3DBiocad. The 510(k) number is K193055.

When did Purzir Dental Zirconia receive FDA 510(k) clearance?

Purzir Dental Zirconia received FDA 510(k) clearance on 2020-05-13, under 510(k) number K193055.

Who is the listed applicant for Purzir Dental Zirconia?

The FDA 510(k) record lists 3DBiocad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Purzir Dental Zirconia?

The FDA product code for Purzir Dental Zirconia is EIH.

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.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.