FDA 510(k)

Z-CAD smile

K-Number: K170050 · 2018-08-23

Decision Date2018-08-23

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Z-CAD smile is the device name listed in this FDA 510(k) record. The listed applicant is Metoxit AG. It received FDA 510(k) clearance on 2018-08-23 under 510(k) number K170050. 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 Z-CAD smile?

Z-CAD smile is a medical device that received FDA 510(k) clearance on 2018-08-23. The listed applicant is Metoxit AG. The 510(k) number is K170050.

When did Z-CAD smile receive FDA 510(k) clearance?

Z-CAD smile received FDA 510(k) clearance on 2018-08-23, under 510(k) number K170050.

Who is the listed applicant for Z-CAD smile?

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

What is the FDA product code for Z-CAD smile?

The FDA product code for Z-CAD smile 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.