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FDA 510(k)

ORIGIN ZIRCONIA

K-Number: K110719 · 2011-08-11

ApplicantB&D Dental Technologies
Decision Date2011-08-11
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORIGIN ZIRCONIA is the device name listed in this FDA 510(k) record. The listed applicant is B&D Dental Technologies. It received FDA 510(k) clearance on 2011-08-11 under 510(k) number K110719. 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 ORIGIN ZIRCONIA?

ORIGIN ZIRCONIA is a medical device that received FDA 510(k) clearance on 2011-08-11. The listed applicant is B&D Dental Technologies. The 510(k) number is K110719.

When did ORIGIN ZIRCONIA receive FDA 510(k) clearance?

ORIGIN ZIRCONIA received FDA 510(k) clearance on 2011-08-11, under 510(k) number K110719.

Who is the listed applicant for ORIGIN ZIRCONIA?

The FDA 510(k) record lists B&D Dental Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORIGIN ZIRCONIA?

The FDA product code for ORIGIN 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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