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FDA 510(k)

Ceramill Zolid HT+ white

K-Number: K171876 · 2017-09-20

ApplicantAmann Girrbach AG
Decision Date2017-09-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ceramill Zolid HT+ white is the device name listed in this FDA 510(k) record. The listed applicant is Amann Girrbach AG. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K171876. 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 Ceramill Zolid HT+ white?

Ceramill Zolid HT+ white is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Amann Girrbach AG. The 510(k) number is K171876.

When did Ceramill Zolid HT+ white receive FDA 510(k) clearance?

Ceramill Zolid HT+ white received FDA 510(k) clearance on 2017-09-20, under 510(k) number K171876.

Who is the listed applicant for Ceramill Zolid HT+ white?

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

What is the FDA product code for Ceramill Zolid HT+ white?

The FDA product code for Ceramill Zolid HT+ white is EIH.

Other records listing Amann Girrbach AG 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.

K260918Zolid LunarisK191836Ceramill A-SplintK191843Ceramill A-Temp

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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