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FDA 510(k)

AVANTE LEUCITE BLOCKS

K-Number: K090684 · 2009-05-01

ApplicantSomerset Dental Products, Inc.
Decision Date2009-05-01
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AVANTE LEUCITE BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Somerset Dental Products, Inc.. It received FDA 510(k) clearance on 2009-05-01 under 510(k) number K090684. 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 AVANTE LEUCITE BLOCKS?

AVANTE LEUCITE BLOCKS is a medical device that received FDA 510(k) clearance on 2009-05-01. The listed applicant is Somerset Dental Products, Inc.. The 510(k) number is K090684.

When did AVANTE LEUCITE BLOCKS receive FDA 510(k) clearance?

AVANTE LEUCITE BLOCKS received FDA 510(k) clearance on 2009-05-01, under 510(k) number K090684.

Who is the listed applicant for AVANTE LEUCITE BLOCKS?

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

What is the FDA product code for AVANTE LEUCITE BLOCKS?

The FDA product code for AVANTE LEUCITE BLOCKS is EIH.

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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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