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FDA 510(k)

XAWEX G 100

K-Number: K050903 · 2005-06-23

ApplicantWieland Dental + Technik GmbH & Co. KG
Decision Date2005-06-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XAWEX G 100 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 2005-06-23 under 510(k) number K050903. 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 XAWEX G 100?

XAWEX G 100 is a medical device that received FDA 510(k) clearance on 2005-06-23. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. The 510(k) number is K050903.

When did XAWEX G 100 receive FDA 510(k) clearance?

XAWEX G 100 received FDA 510(k) clearance on 2005-06-23, under 510(k) number K050903.

Who is the listed applicant for XAWEX G 100?

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 XAWEX G 100?

The FDA product code for XAWEX G 100 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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