E-connect S Endo Motor with built-in Apex Locator— 510(k) K201993

Name: FDA 510(k) clearance K201993
Creator: U.S. Food and Drug Administration
Published: 2021-01-29

Substantially Equivalent

Changzhou Sifary Medical Technology Co., Ltd.

FDA 510(k) clearance K201993 for E-connect S Endo Motor with built-in Apex Locator, Substantially Equivalent on 2021-01-29. Applicant: Changzhou Sifary Medical Technology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Changzhou Sifary Medical Technology Co., Ltd.
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2020-07-17
Decision date: 2021-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, 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.