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FDA 510(k)

ZENOSTAR MAGIC GLAZE

K-Number: K103494 · 2011-02-16

ApplicantWieland Dental + Technik GmbH & Co. KG
Decision Date2011-02-16
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENOSTAR MAGIC GLAZE 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 2011-02-16 under 510(k) number K103494. 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 ZENOSTAR MAGIC GLAZE?

ZENOSTAR MAGIC GLAZE is a medical device that received FDA 510(k) clearance on 2011-02-16. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. The 510(k) number is K103494.

When did ZENOSTAR MAGIC GLAZE receive FDA 510(k) clearance?

ZENOSTAR MAGIC GLAZE received FDA 510(k) clearance on 2011-02-16, under 510(k) number K103494.

Who is the listed applicant for ZENOSTAR MAGIC GLAZE?

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 ZENOSTAR MAGIC GLAZE?

The FDA product code for ZENOSTAR MAGIC GLAZE is EIH.

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

K130184ZENOLUXK112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZRK103773ZENOFLEX DIMENSIONK082257ZENO AI ECO DISCK080182ZENO PMMA DISCK073108ZENO ZR DISC

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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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