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FDA 510(k)

CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA

K-Number: K113431 · 2012-03-30

ApplicantBettini S.P.A.
Decision Date2012-03-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA is the device name listed in this FDA 510(k) record. The listed applicant is Bettini S.P.A.. It received FDA 510(k) clearance on 2012-03-30 under 510(k) number K113431. 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 CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA?

CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA is a medical device that received FDA 510(k) clearance on 2012-03-30. The listed applicant is Bettini S.P.A.. The 510(k) number is K113431.

When did CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA receive FDA 510(k) clearance?

CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA received FDA 510(k) clearance on 2012-03-30, under 510(k) number K113431.

Who is the listed applicant for CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA?

The FDA 510(k) record lists Bettini S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA?

The FDA product code for CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA 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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