Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank— 510(k) K212765

Name: FDA 510(k) clearance K212765
Creator: U.S. Food and Drug Administration
Published: 2021-11-15

Substantially Equivalent

Bloomden Bioceramics (HuNan) Co., Ltd.

FDA 510(k) clearance K212765 for Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Substantially Equivalent on 2021-11-15. Applicant: Bloomden Bioceramics (HuNan) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bloomden Bioceramics (HuNan) Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2021-08-31
Decision date: 2021-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

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