Ultrasonic Scaler Tips
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230641 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)
Ultrasonic Scaler Tips are disposable, handpiece-compatible attachments designed for ultrasonic dental scaling. These tips generate high-frequency vibrations to remove plaque, calculus, and biofilm from teeth surfaces during periodontal and restorative procedures, aiding in subgingival cleaning and root debridement.
The tips are supplied as single-use, non-sterile devices intended for use with compatible ultrasonic dental scalers in clinical dental settings. They are classified as Class II devices under FDA regulations (21 CFR 872.4850) and have received FDA 510(k) clearance (K230641) as substantially equivalent to predicate devices. Multiple tip sizes and designs are available for various clinical applications, and they must be discarded after a single use to ensure patient safety and infection control.
Frequently asked questions
Are these ultrasonic scaler tips designed for reuse or single-use, and why does that matter?
These ultrasonic scaler tips are explicitly designed for single-use only. The manufacturer emphasizes this to ensure patient safety and infection control, as reuse could introduce cross-contamination risks. Since they are non-sterile as supplied, each tip is intended for one procedure, reducing the risk of bacterial transmission between patients.
What types of dental procedures are these tips intended to assist with, and how do they work?
These tips are designed for periodontal and restorative dental procedures, specifically to remove plaque, calculus, and biofilm from teeth surfaces. They generate high-frequency vibrations when attached to a compatible ultrasonic scaler, enabling effective subgingival cleaning and root debridement. The varied tip sizes and designs cater to different clinical needs, such as precision in tight spaces or broader surface cleaning.
How should these tips be stored, and what should I consider before use?
The tips are supplied as non-sterile, so they must be sterilized by the user before clinical use if required (e.g., via autoclave or chemical sterilization). Storage should follow standard dental instrument protocols—keep them in a clean, dry environment away from direct sunlight or moisture to preserve their integrity. Always check the packaging for expiration dates or damage before use, as compromised tips could affect performance or safety.
Are there multiple sizes or models available, and how do I know which one to choose?
Yes, multiple tip sizes and designs are available, as indicated by the varied registration numbers in the FDA database. The selection depends on the clinical application—some may be optimized for precision work in periodontal pockets, while others may offer a broader surface area for general scaling. Consult the manufacturer’s documentation or your dental supplier for guidance on matching the tip to your specific procedure needs.
What regulatory pathway was followed for FDA clearance, and what does that mean for me as a buyer?
The tips received FDA 510(k) clearance (K230641) under the Traditional 510(k) Review pathway, determined to be substantially equivalent to predicate devices. This means the FDA reviewed the design, manufacturing processes, and clinical performance to confirm they meet safety and effectiveness standards for ultrasonic dental scalers. As a buyer, this clearance indicates the product has undergone regulatory scrutiny, but you should still verify compatibility with your specific ultrasonic scaler model and follow the manufacturer’s instructions for 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: Ultrasonic Scaler Tips (K230641) - FDA 510 (k), Guilin Refine Medical Instrument Co., Ltd. 510 (k) Products, Dental Equipment, Root Canal Dental Instruments|Refine Medical, Professional Medical Dental Equipment Manufacturer, Supplier|Refine Medical, Ultrasonic Scaler Instruction Manual (Series 3/5/6/7)
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 | K230641 | Class II | Active |
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Manufacturer
- Manufacturer
- Guilin Refine Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K230641 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026