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FDA 510(k)

X-cera Pre-shaded Zirconia Blanks

K-Number: K202673 · 2020-12-10

ApplicantDongguan Xiangtong Co., Ltd.
Decision Date2020-12-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-cera Pre-shaded Zirconia Blanks is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Xiangtong Co., Ltd.. It received FDA 510(k) clearance on 2020-12-10 under 510(k) number K202673. 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 X-cera Pre-shaded Zirconia Blanks?

X-cera Pre-shaded Zirconia Blanks is a medical device that received FDA 510(k) clearance on 2020-12-10. The listed applicant is Dongguan Xiangtong Co., Ltd.. The 510(k) number is K202673.

When did X-cera Pre-shaded Zirconia Blanks receive FDA 510(k) clearance?

X-cera Pre-shaded Zirconia Blanks received FDA 510(k) clearance on 2020-12-10, under 510(k) number K202673.

Who is the listed applicant for X-cera Pre-shaded Zirconia Blanks?

The FDA 510(k) record lists Dongguan Xiangtong Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-cera Pre-shaded Zirconia Blanks?

The FDA product code for X-cera Pre-shaded Zirconia Blanks is EIH.

Other records listing Dongguan Xiangtong Co., Ltd. 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.

K220017Coloring Liquid

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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