FDA 510(k)

CEREC SpeedGlaze

K-Number: K160099 · 2016-06-02

Decision Date2016-06-02

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CEREC SpeedGlaze is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K160099. 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 CEREC SpeedGlaze?

CEREC SpeedGlaze is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K160099.

When did CEREC SpeedGlaze receive FDA 510(k) clearance?

CEREC SpeedGlaze received FDA 510(k) clearance on 2016-06-02, under 510(k) number K160099.

Who is the listed applicant for CEREC SpeedGlaze?

The FDA 510(k) record lists Sirona Dental Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEREC SpeedGlaze?

The FDA product code for CEREC SpeedGlaze 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.