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FDA 510(k)

LUMINESSE ZR BLANKS

K-Number: K100232 · 2010-05-21

ApplicantTalladium, Inc.
Decision Date2010-05-21
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUMINESSE ZR BLANKS is the device name listed in this FDA 510(k) record. The listed applicant is Talladium, Inc.. It received FDA 510(k) clearance on 2010-05-21 under 510(k) number K100232. 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 LUMINESSE ZR BLANKS?

LUMINESSE ZR BLANKS is a medical device that received FDA 510(k) clearance on 2010-05-21. The listed applicant is Talladium, Inc.. The 510(k) number is K100232.

When did LUMINESSE ZR BLANKS receive FDA 510(k) clearance?

LUMINESSE ZR BLANKS received FDA 510(k) clearance on 2010-05-21, under 510(k) number K100232.

Who is the listed applicant for LUMINESSE ZR BLANKS?

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

What is the FDA product code for LUMINESSE ZR BLANKS?

The FDA product code for LUMINESSE ZR BLANKS is EIH.

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Other records listing Talladium, 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.

K152023Luminesse Shaded Zirconia SZK894085TALLADIUM TILITE CERAMIC ALLOY

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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