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FDA 510(k)

CDC ZIRCONIA BLANKS

K-Number: K122972 · 2012-10-24

ApplicantContinental Dental Ceramics, Inc. (Dba Continental
Decision Date2012-10-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CDC ZIRCONIA BLANKS is the device name listed in this FDA 510(k) record. The listed applicant is Continental Dental Ceramics, Inc. (Dba Continental. It received FDA 510(k) clearance on 2012-10-24 under 510(k) number K122972. 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 CDC ZIRCONIA BLANKS?

CDC ZIRCONIA BLANKS is a medical device that received FDA 510(k) clearance on 2012-10-24. The listed applicant is Continental Dental Ceramics, Inc. (Dba Continental. The 510(k) number is K122972.

When did CDC ZIRCONIA BLANKS receive FDA 510(k) clearance?

CDC ZIRCONIA BLANKS received FDA 510(k) clearance on 2012-10-24, under 510(k) number K122972.

Who is the listed applicant for CDC ZIRCONIA BLANKS?

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

What is the FDA product code for CDC ZIRCONIA BLANKS?

The FDA product code for CDC ZIRCONIA BLANKS 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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