Panoura X-ERA PF/NF/MF— 510(k) K182198

Name: FDA 510(k) clearance K182198
Creator: U.S. Food and Drug Administration
Published: 2019-01-31

Substantially Equivalent

The Yoshida Dental Mfg. Co., Ltd.

FDA 510(k) clearance K182198 for Panoura X-ERA PF/NF/MF, Substantially Equivalent on 2019-01-31. Applicant: The Yoshida Dental Mfg. Co., Ltd.. Device class: 2.

Clearance details

Applicant: The Yoshida Dental Mfg. Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2018-08-14
Decision date: 2019-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sumida-Ku, JP

Download summary PDF View on FDA.gov ↗

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