FDA 510(k)

Zirconia Block

Numéro K : K233125 · 2024-01-12

DemandeurHangzhou Ivista Medical Devices Co., Ltd.

Date de décision2024-01-12

Code produitEIH

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

Zirconia Block is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Ivista Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233125. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Zirconia Block?

Zirconia Block is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Hangzhou Ivista Medical Devices Co., Ltd.. The 510(k) number is K233125.

When did Zirconia Block receive FDA 510(k) clearance?

Zirconia Block received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233125.

Who is the listed applicant for Zirconia Block?

The FDA 510(k) record lists Hangzhou Ivista Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zirconia Block?

The FDA product code for Zirconia Block is EIH.

Essais cliniques associés

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Dispositifs connexes (Code : EIH)

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 Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.

Source officielle

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