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FDA 510(k)

Perfit FS Dental Zirconia Fully Sintered Block

K-Number: K203590 · 2021-06-24

ApplicantVatech Acucera, Inc.
Decision Date2021-06-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Perfit FS Dental Zirconia Fully Sintered Block 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 2021-06-24 under 510(k) number K203590. 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 FS Dental Zirconia Fully Sintered Block?

Perfit FS Dental Zirconia Fully Sintered Block is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Vatech Acucera, Inc.. The 510(k) number is K203590.

When did Perfit FS Dental Zirconia Fully Sintered Block receive FDA 510(k) clearance?

Perfit FS Dental Zirconia Fully Sintered Block received FDA 510(k) clearance on 2021-06-24, under 510(k) number K203590.

Who is the listed applicant for Perfit FS Dental Zirconia Fully Sintered Block?

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 FS Dental Zirconia Fully Sintered Block?

The FDA product code for Perfit FS Dental Zirconia Fully Sintered Block 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 BlockK203499Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blankK203351Perfit 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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