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FDA 510(k)

DC - CRISTAL

K-Number: K011674 · 2001-09-04

ApplicantAustenal, Inc.
Decision Date2001-09-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DC - CRISTAL is the device name listed in this FDA 510(k) record. The listed applicant is Austenal, Inc.. It received FDA 510(k) clearance on 2001-09-04 under 510(k) number K011674. 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 - CRISTAL?

DC - CRISTAL is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Austenal, Inc.. The 510(k) number is K011674.

When did DC - CRISTAL receive FDA 510(k) clearance?

DC - CRISTAL received FDA 510(k) clearance on 2001-09-04, under 510(k) number K011674.

Who is the listed applicant for DC - CRISTAL?

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 - CRISTAL?

The FDA product code for DC - CRISTAL 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.

K001799DC-TELLK001815DC ZIRKONK001798DC 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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