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FDA 510(k)

PRISMATIK CERAMIC

K-Number: K050144 · 2005-03-03

ApplicantGlidewell Laboratories
Decision Date2005-03-03
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRISMATIK CERAMIC is the device name listed in this FDA 510(k) record. The listed applicant is Glidewell Laboratories. It received FDA 510(k) clearance on 2005-03-03 under 510(k) number K050144. 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 PRISMATIK CERAMIC?

PRISMATIK CERAMIC is a medical device that received FDA 510(k) clearance on 2005-03-03. The listed applicant is Glidewell Laboratories. The 510(k) number is K050144.

When did PRISMATIK CERAMIC receive FDA 510(k) clearance?

PRISMATIK CERAMIC received FDA 510(k) clearance on 2005-03-03, under 510(k) number K050144.

Who is the listed applicant for PRISMATIK CERAMIC?

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

What is the FDA product code for PRISMATIK CERAMIC?

The FDA product code for PRISMATIK CERAMIC is EIH.

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Other records listing Glidewell Laboratories 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.

K060104PRISMATIK CLINICAL ZIRCONIAK972424SILENTNITE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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