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FDA 510(k)

ZENOFLEX DIMENSION

K-Number: K103773 · 2011-03-16

ApplicantWieland Dental + Technik GmbH & Co. KG
Decision Date2011-03-16
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENOFLEX DIMENSION is the device name listed in this FDA 510(k) record. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. It received FDA 510(k) clearance on 2011-03-16 under 510(k) number K103773. 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 ZENOFLEX DIMENSION?

ZENOFLEX DIMENSION is a medical device that received FDA 510(k) clearance on 2011-03-16. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. The 510(k) number is K103773.

When did ZENOFLEX DIMENSION receive FDA 510(k) clearance?

ZENOFLEX DIMENSION received FDA 510(k) clearance on 2011-03-16, under 510(k) number K103773.

Who is the listed applicant for ZENOFLEX DIMENSION?

The FDA 510(k) record lists Wieland Dental + Technik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZENOFLEX DIMENSION?

The FDA product code for ZENOFLEX DIMENSION is EIH.

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Other records listing Wieland Dental + Technik GmbH & Co. KG as applicant

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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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