Identifiers
- 510(k) Number
- K222096 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 Endo Ultrasonic Activator is a scaler, ultrasonic device. It is classified as a class 2 device. The device is used in the dental field.
The Endo Ultrasonic Activator is supplied with the specification that it has a regulation number of 872.4850 and a product code of ELC. It is authorized with an FDA 510K clearance. The device has various registration numbers and fei numbers associated with it.
Frequently asked questions
What is the Endo Ultrasonic Activator used for?
The Endo Ultrasonic Activator is used in the dental field for scaling and other dental procedures.
Is the Endo Ultrasonic Activator cleared by the FDA?
Yes, the Endo Ultrasonic Activator has received FDA 510K clearance, indicating it is substantially equivalent to a predicate device.
What is the product code for the Endo Ultrasonic Activator?
The product code for the Endo Ultrasonic Activator is ELC, and it is classified as a class 2 device with regulation number 872.4850.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222096 | Class II | Active |
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Manufacturer
- Manufacturer
- Foshan COXO Medical Instrument Co., Ltd.
Sources (1)
- FDA 510(k) K222096 24 fields · synced Oct 6, 2026