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FDA 510(k)

Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank

K-Number: K203499 · 2021-04-05

ApplicantVatech Acucera, Inc.
Decision Date2021-04-05
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank is the device name listed in this FDA 510(k) record. The listed applicant is Vatech Acucera, Inc.. It received FDA 510(k) clearance on 2021-04-05 under 510(k) number K203499. 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 Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank?

Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank is a medical device that received FDA 510(k) clearance on 2021-04-05. The listed applicant is Vatech Acucera, Inc.. The 510(k) number is K203499.

When did Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank receive FDA 510(k) clearance?

Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank received FDA 510(k) clearance on 2021-04-05, under 510(k) number K203499.

Who is the listed applicant for Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank?

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

What is the FDA product code for Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank?

The FDA product code for Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank is EIH.

Other records listing Vatech Acucera, 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.

K222686Perfit FS Dental Zirconia Fully Sintered BlockK203590Perfit FS Dental Zirconia Fully Sintered BlockK203351Perfit ZR HT Dental Zirconia blank

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 DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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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