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FDA 510(k)

ZircaGlow & ZircaGlow HT Zirconia

K-Number: K250393 · 2025-05-12

ApplicantUnited Zirconia
Decision Date2025-05-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZircaGlow & ZircaGlow HT Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is United Zirconia. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K250393. 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 ZircaGlow & ZircaGlow HT Zirconia?

ZircaGlow & ZircaGlow HT Zirconia is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is United Zirconia. The 510(k) number is K250393.

When did ZircaGlow & ZircaGlow HT Zirconia receive FDA 510(k) clearance?

ZircaGlow & ZircaGlow HT Zirconia received FDA 510(k) clearance on 2025-05-12, under 510(k) number K250393.

Who is the listed applicant for ZircaGlow & ZircaGlow HT Zirconia?

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

What is the FDA product code for ZircaGlow & ZircaGlow HT Zirconia?

The FDA product code for ZircaGlow & ZircaGlow HT Zirconia 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 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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