Ultrasonic Endo Activation Device (Model:Actor I pro)
K-Number: K213947 · 2022-09-08
Device Summary
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. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K213947.
When did Ultrasonic Endo Activation Device (Model:Actor I pro) receive FDA 510(k) clearance?
Ultrasonic Endo Activation Device (Model:Actor I pro) received FDA 510(k) clearance on 2022-09-08, under 510(k) number K213947.
Who is the listed applicant for Ultrasonic Endo Activation Device (Model:Actor I 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 Ultrasonic Endo Activation Device (Model:Actor I pro)?
The FDA product code for Ultrasonic Endo Activation Device (Model:Actor I pro) is ELC.
Other records listing Changzhou Bomedent Medical Technology Co.,Ltd as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: ELC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.