Dental Electrical Motor iRoot Pro— 510(k) K191276

Name: FDA 510(k) clearance K191276
Creator: U.S. Food and Drug Administration
Published: 2020-06-30

Substantially Equivalent

Changzhou Bomedent Medical Technology Co.,Ltd

FDA 510(k) clearance K191276 for Dental Electrical Motor iRoot Pro, Substantially Equivalent on 2020-06-30. Applicant: Changzhou Bomedent Medical Technology Co.,Ltd. Device class: 1.

Clearance details

Applicant: Changzhou Bomedent Medical Technology Co.,Ltd
Product code: Code EKX
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2019-05-13
Decision date: 2020-06-30
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.