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FDA 510(k)

PV-CERAMIC, CERAMINIQUE

K-Number: K901261 · 1990-06-26

ApplicantIvoclar North America, Inc.
Decision Date1990-06-26
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PV-CERAMIC, CERAMINIQUE is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1990-06-26 under 510(k) number K901261. 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 PV-CERAMIC, CERAMINIQUE?

PV-CERAMIC, CERAMINIQUE is a medical device that received FDA 510(k) clearance on 1990-06-26. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K901261.

When did PV-CERAMIC, CERAMINIQUE receive FDA 510(k) clearance?

PV-CERAMIC, CERAMINIQUE received FDA 510(k) clearance on 1990-06-26, under 510(k) number K901261.

Who is the listed applicant for PV-CERAMIC, CERAMINIQUE?

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

What is the FDA product code for PV-CERAMIC, CERAMINIQUE?

The FDA product code for PV-CERAMIC, CERAMINIQUE is EIH.

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Other records listing Ivoclar North America, 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

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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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