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FDA 510(k)

Ultrasonic Endo Activation Device (Model:Actor I pro)

K-Number: K213947 · 2022-09-08

ApplicantChangzhou Bomedent Medical Technology Co.,Ltd
Decision Date2022-09-08
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Endo Activation Device (Model:Actor I pro) is a medical device manufactured by Changzhou Bomedent Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-09-08 under approval number K213947. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Endo Activation Device (Model:Actor I pro)?

Ultrasonic Endo Activation Device (Model:Actor I pro) is a medical device that received FDA 510(k) clearance on 2022-09-08. It is manufactured by Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K213947.

When was Ultrasonic Endo Activation Device (Model:Actor I pro) approved by the FDA?

Ultrasonic Endo Activation Device (Model:Actor I pro) received FDA 510(k) clearance on 2022-09-08, under approval number K213947.

What company makes Ultrasonic Endo Activation Device (Model:Actor I pro)?

Ultrasonic Endo Activation Device (Model:Actor I pro) is manufactured by Changzhou Bomedent Medical Technology Co.,Ltd.

What is the FDA product code for Ultrasonic Endo Activation Device (Model:Actor I pro)?

The FDA product code for Ultrasonic Endo Activation Device (Model:Actor I pro) is ELC.

Related Clinical Trials

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40408133 A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of medical Internet research (2025)

Other Devices by Changzhou Bomedent Medical Technology Co.,Ltd

K191276Dental Electrical Motor iRoot Pro K203836BOMEDENT Apex locator, WISMY Apex locator

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Official Source

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

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