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FDA 510(k)

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

K-Number: K212765 · 2021-11-15

ApplicantBloomden Bioceramics (HuNan) Co., Ltd.
Decision Date2021-11-15
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Bloomden Bioceramics (HuNan) Co., Ltd.. It received FDA 510(k) clearance on 2021-11-15 under 510(k) number K212765. 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 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2021-11-15. The listed applicant is Bloomden Bioceramics (HuNan) Co., Ltd.. The 510(k) number is K212765.

When did Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2021-11-15, under 510(k) number K212765.

Who is the listed applicant for Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA 510(k) record lists Bloomden Bioceramics (HuNan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA product code for Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.

Other records listing Bloomden Bioceramics (HuNan) Co., Ltd. as applicant

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.

K260370Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

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.

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.K253191DCMhotbond zirconDental Creativ Management GmbH

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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