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FDA 510(k)

BITTAR ZIRCONIA BLOCKS

K-Number: K082652 · 2008-12-30

ApplicantBittar Zirconia Block, LLC
Decision Date2008-12-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BITTAR ZIRCONIA BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Bittar Zirconia Block, LLC. It received FDA 510(k) clearance on 2008-12-30 under 510(k) number K082652. 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 BITTAR ZIRCONIA BLOCKS?

BITTAR ZIRCONIA BLOCKS is a medical device that received FDA 510(k) clearance on 2008-12-30. The listed applicant is Bittar Zirconia Block, LLC. The 510(k) number is K082652.

When did BITTAR ZIRCONIA BLOCKS receive FDA 510(k) clearance?

BITTAR ZIRCONIA BLOCKS received FDA 510(k) clearance on 2008-12-30, under 510(k) number K082652.

Who is the listed applicant for BITTAR ZIRCONIA BLOCKS?

The FDA 510(k) record lists Bittar Zirconia Block, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BITTAR ZIRCONIA BLOCKS?

The FDA product code for BITTAR ZIRCONIA 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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