Identifiers
- 510(k) Number
- K140233 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 Scaler is a dental device classified as a Scaler, Ultrasonic, designed for the removal of dental plaque, calculus, and stains from teeth surfaces. It operates using high-frequency ultrasonic vibrations to disrupt and loosen deposits, facilitating their removal during professional dental cleaning procedures. The device is intended for use in clinical settings by dental professionals to enhance oral hygiene and prevent periodontal disease.
This device is supplied as a reusable, non-sterile instrument, intended for use in dental offices and clinics. It is regulated under FDA classification 2, with a 510K clearance (K140233) for dental applications. Multiple model references (e.g., 3038718579, 2127132) are listed under regulatory records, though specific sizes or MRI safety information are not provided. Compliance with 21 CFR 872.4850 applies, and the device is not marked as single-use or sterile. Storage and maintenance follow manufacturer guidelines for reusable dental instruments.
Frequently asked questions
What is the primary use of the Ultrasonic Scaler 3038718579?
The Ultrasonic Scaler 3038718579 is designed for dental professionals to remove dental plaque, calculus, and stains from tooth surfaces during professional cleanings. It uses high-frequency ultrasonic vibrations to disrupt and loosen deposits, improving oral hygiene and reducing the risk of periodontal disease.
Is this device single-use or reusable?
This ultrasonic scaler is intended for reusable use in clinical settings. It is not marked as single-use, meaning it must be properly cleaned, maintained, and sterilized between uses according to manufacturer guidelines for reusable dental instruments.
What regulatory approvals does the Ultrasonic Scaler 3038718579 hold?
The device holds FDA 510K clearance (K140233) under classification 2, indicating it has been deemed substantially equivalent to a legally marketed predicate device. It complies with 21 CFR 872.4850 and is regulated for dental applications.
Are there multiple model references for this device?
Yes, this ultrasonic scaler is associated with multiple model references, including 3038718579, 2127132, and others listed under regulatory records. These references may correspond to variations or different regulatory submissions, but specific details on size or functionality differences are not provided in the data.
How should this device be stored and maintained?
The device must be stored and maintained according to the manufacturer’s guidelines for reusable dental instruments. Since it is non-sterile and reusable, proper cleaning, disinfection, and storage procedures are essential to prevent cross-contamination and ensure longevity.
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: Baolai Medical, Company Overview - NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD., Nanning Baolai Medical Instrument Co., Ltd. - Made-in-China.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140233 | Class II | Active |
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Manufacturer
- Manufacturer
- Nanning Baolai Medical Instrument Co., Ltd.
Sources (1)
- FDA 510(k) K140233 24 fields · synced Oct 6, 2026