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FDA 510(k)

ARGEN PEARL BRAND ZIRCONIA

K-Number: K071410 · 2007-08-15

ApplicantThe Argen Corporation
Decision Date2007-08-15
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARGEN PEARL BRAND ZIRCONIA is the device name listed in this FDA 510(k) record. The listed applicant is The Argen Corporation. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K071410. 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 ARGEN PEARL BRAND ZIRCONIA?

ARGEN PEARL BRAND ZIRCONIA is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is The Argen Corporation. The 510(k) number is K071410.

When did ARGEN PEARL BRAND ZIRCONIA receive FDA 510(k) clearance?

ARGEN PEARL BRAND ZIRCONIA received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071410.

Who is the listed applicant for ARGEN PEARL BRAND ZIRCONIA?

The FDA 510(k) record lists The Argen Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGEN PEARL BRAND ZIRCONIA?

The FDA product code for ARGEN PEARL BRAND ZIRCONIA is EIH.

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Other records listing The Argen Corporation 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.

K190079ArgenZ HT+K182833ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer

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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