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FDA 510(k)

DC ZIRKON

K-Number: K001815 · 2000-08-10

ApplicantAustenal, Inc.
Decision Date2000-08-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DC ZIRKON is the device name listed in this FDA 510(k) record. The listed applicant is Austenal, Inc.. It received FDA 510(k) clearance on 2000-08-10 under 510(k) number K001815. 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 DC ZIRKON?

DC ZIRKON is a medical device that received FDA 510(k) clearance on 2000-08-10. The listed applicant is Austenal, Inc.. The 510(k) number is K001815.

When did DC ZIRKON receive FDA 510(k) clearance?

DC ZIRKON received FDA 510(k) clearance on 2000-08-10, under 510(k) number K001815.

Who is the listed applicant for DC ZIRKON?

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

What is the FDA product code for DC ZIRKON?

The FDA product code for DC ZIRKON is EIH.

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Other records listing Austenal, Inc. 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.

K011674DC - CRISTALK001799DC-TELLK001798DC TITANK970522MYERSON'S ECONOMY DENTURE BASE MATERIALK970205VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOYK955509MIDAS GOLD ELECTROFORMING SYSTEM

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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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