Cleared Traditional

Dental Electrical Motor iRoot Pro

K191276 · Changzhou Bomedent Medical Technology Co.,Ltd · Dental

Jun 2020

Decision

414d

Days

Class 1

Risk

About This 510(k) Submission

K191276 is an FDA 510(k) clearance for the Dental Electrical Motor iRoot Pro, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Changzhou Bomedent Medical Technology Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on June 30, 2020, 414 days after receiving the submission on May 13, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K191276 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2019
Decision Date	June 30, 2020
Days to Decision	414 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF