Dental Impression Material— 510(k) K211489

Name: FDA 510(k) clearance K211489
Creator: U.S. Food and Drug Administration
Published: 2021-07-28

Substantially Equivalent

Nanchang Dental Bright Technology Co., Ltd.

FDA 510(k) clearance K211489 for Dental Impression Material, Substantially Equivalent on 2021-07-28. Applicant: Nanchang Dental Bright Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nanchang Dental Bright Technology Co., Ltd.
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2021-05-13
Decision date: 2021-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanchang, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.