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FDA 510(k)

BECE CAD ZIRKON HT+

K-Number: K132102 · 2013-11-12

ApplicantBego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
Decision Date2013-11-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BECE CAD ZIRKON HT+ is the device name listed in this FDA 510(k) record. The listed applicant is Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO. It received FDA 510(k) clearance on 2013-11-12 under 510(k) number K132102. 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 BECE CAD ZIRKON HT+?

BECE CAD ZIRKON HT+ is a medical device that received FDA 510(k) clearance on 2013-11-12. The listed applicant is Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO. The 510(k) number is K132102.

When did BECE CAD ZIRKON HT+ receive FDA 510(k) clearance?

BECE CAD ZIRKON HT+ received FDA 510(k) clearance on 2013-11-12, under 510(k) number K132102.

Who is the listed applicant for BECE CAD ZIRKON HT+?

The FDA 510(k) record lists Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BECE CAD ZIRKON HT+?

The FDA product code for BECE CAD ZIRKON HT+ is EIH.

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Other records listing Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO 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.

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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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