FDA 510(k)

Shaders ZR

K-Number: K190569 · 2019-07-29

Decision Date2019-07-29

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Shaders ZR is the device name listed in this FDA 510(k) record. The listed applicant is Digital Age Dental Lab. It received FDA 510(k) clearance on 2019-07-29 under 510(k) number K190569. 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 Shaders ZR?

Shaders ZR is a medical device that received FDA 510(k) clearance on 2019-07-29. The listed applicant is Digital Age Dental Lab. The 510(k) number is K190569.

When did Shaders ZR receive FDA 510(k) clearance?

Shaders ZR received FDA 510(k) clearance on 2019-07-29, under 510(k) number K190569.

Who is the listed applicant for Shaders ZR?

The FDA 510(k) record lists Digital Age Dental Lab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shaders ZR?

The FDA product code for Shaders ZR 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.