đź“Š Evidence-Based Reference
Ultrasonic Scaler TIPS
Guilin Refine Medical Instrument
Summary: Ultrasonic scaler tips by Guilin Refine Medical Instrument are used for dental cleaning, particularly around implants. Key evidence highlights their role in biofilm removal through cavitation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K230641 ↗
Decision Date ?
November 21, 2023
Product Code ?
ELC
Device Class ?
Class 2
Evidence ?
0 studies
The ultrasonic scaler tips by Guilin Refine Medical Instrument received FDA clearance via the 510(k) pathway on November 21, 2023. They are classified as Class 2 medical devices.
What It Is
Ultrasonic scaler tips are dental instruments designed to remove biofilm and calculus from teeth and implants using ultrasonic vibrations. They are intended for use in dental hygiene and periodontal therapy.
FDA-Cleared Indications
- For use with compatible ultrasonic dental scaling systems to remove deposits from teeth.
- For dental cleaning and periodontal therapy involving natural teeth.
- For cleaning around dental implants when used with an appropriate implant-compatible tip.
Clinical Applications
- Removal of calculus and other deposits during professional dental cleaning.
- Removal of bacterial biofilm from natural teeth.
- Cleaning around dental implants with an implant-compatible ultrasonic tip.
- Use during periodontal maintenance and nonsurgical periodontal therapy.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and prospective studies, conducted between 2014 and 2020. These studies investigate the efficacy and safety of ultrasonic scaler tips.
Reported Outcomes
Published studies report that ultrasonic scaler tips effectively remove biofilm and calculus without damaging implant surfaces. Cavitation generated by these tips enhances cleaning efficiency, although the extent of cavitation varies among devices.
Safety Profile
Reported complications include potential surface alterations on titanium implants, though these are generally minimal. The safety profile is considered acceptable when used as intended.
Evidence Limitations
Current evidence is limited by small sample sizes and variability in study designs. Further research is needed to optimize cavitation effects and assess long-term outcomes of ultrasonic scaler use.
Practical Considerations
- Tips are available in different shapes, diameters, and working ends; the appropriate size and design depend on the tooth surface, implant system, and treatment area.
- Use only with a compatible ultrasonic scaler and according to the manufacturer’s instructions for attachment, power settings, irrigation, and operating technique.
- Implant surfaces require tips specifically intended for implant maintenance to reduce the risk of surface damage.
- Inspect tips for wear, deformation, cracks, or excessive shortening and follow the manufacturer’s instructions for cleaning, sterilization, reuse, or disposal.
- MRI safety depends on the specific tip, scaler, and accessories; these devices should not be taken into an MRI environment unless the complete system is specifically labeled as MR Safe or MR Conditional.
Frequently Asked Questions
What are the clinical indications for ultrasonic scaler tips?
Ultrasonic scaler tips are indicated for the removal of dental biofilm and calculus, particularly around dental implants and natural teeth.
What outcomes have been reported in clinical studies?
Studies report effective biofilm and calculus removal with minimal surface damage, enhanced by cavitation effects.
What complications have been reported?
Safety data indicates minimal surface alterations on implants, with an overall acceptable safety profile.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.