Bonart ART-M3II & M4 Ultrasonic Scaler Units with Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052028 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 Bonart ART-M3II & M4 Ultrasonic Scaler Units are dental devices designed for ultrasonic scaling, a non-surgical method to remove plaque and calculus from teeth. These units generate high-frequency vibrations to disrupt and loosen dental deposits, facilitating their removal during dental procedures. They are classified as Class II medical devices under the FDA’s dental category and are intended for use in professional dental settings.
These scaler units are supplied with accessories, including various inserts (e.g., plastic and metal grip types) and a foot switch for operator control. They are reusable, non-sterile devices intended for use in clinical environments where proper sterilization protocols are followed. The units operate at 30 kHz and are compatible with standard dental water supply systems. Authorized under FDA 510(k) clearance (K052028), they adhere to regulatory standards for dental ultrasonic scalers, ensuring safety and performance in professional dental applications.
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: The Marquee™ Ultrasonic Scaling System - BonART Co., Ltd ..., Bonart ART-M3II-30K Ultrasonic Scaler w/ 2 Inserts - amazon.com, BonArt ART-M3II Marquee Magnet Ultrasonic Scaler
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052028 | Class II | Active |
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Manufacturer
- Manufacturer
- Bonart Co., Ltd.
Sources (1)
- FDA 510(k) K052028 24 fields · synced Sep 19, 2026