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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 a medical device manufactured by Changzhou Bomedent Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2020-06-30 under approval 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. It is manufactured by Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K191276.

When was Dental Electrical Motor iRoot Pro approved by the FDA?

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

What company makes Dental Electrical Motor iRoot Pro?

Dental Electrical Motor iRoot Pro is manufactured by Changzhou Bomedent Medical Technology Co.,Ltd.

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

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

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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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