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FDA 510(k)

Dental Electrical Motor iRoot Pro

K-Number: K191276 · 2020-06-30

ApplicantChangzhou Bomedent Medical Technology Co.,Ltd
Decision Date2020-06-30
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Electrical Motor iRoot Pro is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-06-30 under 510(k) number K191276. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Electrical Motor iRoot Pro?

Dental Electrical Motor iRoot Pro is a medical device that received FDA 510(k) clearance on 2020-06-30. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K191276.

When did Dental Electrical Motor iRoot Pro receive FDA 510(k) clearance?

Dental Electrical Motor iRoot Pro received FDA 510(k) clearance on 2020-06-30, under 510(k) number K191276.

Who is the listed applicant for Dental Electrical Motor iRoot Pro?

The FDA 510(k) record lists Changzhou Bomedent Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Electrical Motor iRoot Pro?

The FDA product code for Dental Electrical Motor iRoot Pro is EKX.

Other records listing Changzhou Bomedent Medical Technology Co.,Ltd as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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