Ultrasonic Endo Activation Device (Model: Actor I pro)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213947 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ultrasonic Endo Activation Device (Model: Actor I pro) is a Class II dental ultrasonic scaler designed for endodontic procedures. It employs ultrasonic energy to mechanically activate irrigants within root canals, enhancing debris removal and improving cleaning efficacy during root canal therapy.
This device is intended for single-use in dental settings and is supplied sterile. It is classified under FDA regulation number 872.4850 and has received FDA 510(k) clearance as well as MDR authorization. The device is non-MRI compatible and must be handled according to manufacturer guidelines to ensure proper functionality and sterility.
Frequently asked questions
What is the primary purpose of the Ultrasonic Endo Activation Device (Model: Actor I pro) in dental procedures?
The Ultrasonic Endo Activation Device (Model: Actor I pro) is specifically designed for endodontic procedures to mechanically activate irrigants within root canals. This enhances debris removal and improves cleaning efficacy during root canal therapy by utilizing ultrasonic energy.
Is the Ultrasonic Endo Activation Device (Model: Actor I pro) intended for reuse or single-use in clinical settings?
The device is explicitly intended for single-use in dental settings. This ensures sterility and safety per manufacturer guidelines, preventing cross-contamination between patients.
How is the Ultrasonic Endo Activation Device (Model: Actor I pro) supplied, and what does this mean for its handling?
The device is supplied sterile, meaning it is pre-sterilized and packaged to maintain sterility until use. Clinicians must follow manufacturer instructions to preserve sterility, including proper storage and handling to ensure functionality and safety.
Can the Ultrasonic Endo Activation Device (Model: Actor I pro) be used in an MRI environment, and why?
No, the device is non-MRI compatible. This means it should not be used or stored near MRI machines, as exposure to magnetic fields could compromise its performance or pose safety risks.
What regulatory pathways has the Ultrasonic Endo Activation Device (Model: Actor I pro) followed, and what does this indicate about its compliance?
The device has received FDA 510(k) clearance and MDR authorization, indicating it has undergone regulatory review to demonstrate substantial equivalence to existing devices (per FDA classification 872.4850) and compliance with EU medical device regulations. This confirms its safety and effectiveness for its intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ultrasound - Wikipedia, Startseite - MS Ultrasonic Technology Group, Ultrasonics | Physics, Sound Waves & Applications | Britannica, Ultraschall-Maschinen und Systeme - MS Ultrasonic Technology Group, Ultrasonic transducer - Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213947 | Class II | Active |
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Manufacturer
- Manufacturer
- ChangZhou BoMedent Medical Technology Co., Ltd.
- FDA Applicant
- Changzhou Bomedent Medical Technology Co.,Ltd
Sources (2)
- FDA 510(k) K213947 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026