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FDA 510(k)

CEREC BLOCS C IN

K-Number: K123952 · 2013-03-20

ApplicantSirona Dental Systems GmbH
Decision Date2013-03-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEREC BLOCS C IN 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 2013-03-20 under 510(k) number K123952. 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 BLOCS C IN?

CEREC BLOCS C IN is a medical device that received FDA 510(k) clearance on 2013-03-20. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K123952.

When did CEREC BLOCS C IN receive FDA 510(k) clearance?

CEREC BLOCS C IN received FDA 510(k) clearance on 2013-03-20, under 510(k) number K123952.

Who is the listed applicant for CEREC BLOCS C IN?

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 BLOCS C IN?

The FDA product code for CEREC BLOCS C IN is EIH.

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Other records listing Sirona Dental Systems GmbH 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.

K160099CEREC SpeedGlazeK132773SIDEXIS 4K123664INCORIS ZIK123070GALILEOS FAMILYK123545INCORIS TZIK111421SIRONA DENTAL CAD/CAM SYSTEM

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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.

K262074Any-ZircosMediclus Co., Ltd.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.

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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