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ultrasonic tips
Coopervision
Summary: Ultrasonic tips are used in dental procedures for biofilm removal and root-end preparation. Key evidence highlights their effectiveness in reducing bacterial colonization and improving surface roughness.
FDA Clearance Information
Pathway
510K
Number
K812126 ↗
Decision Date
September 18, 1981
Product Code
HQC
Device Class
Class 2
Evidence
0 studies
Ultrasonic tips by Coopervision were cleared through the FDA 510k pathway on September 18, 1981. They are classified as Class 2 devices under product code HQC.
What It Is
Ultrasonic tips are dental instruments designed to enhance cleaning and preparation of dental structures. They utilize ultrasonic vibrations to aid in the removal of biofilms and preparation of root canals.
Clinical Applications
Commonly used in endodontic procedures, ultrasonic tips assist in the removal of biofilms from dental canals and the preparation of root ends. They are also employed in implant maintenance to preserve surface integrity.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, systematic reviews, and meta-analyses, published between 2021 and 2025. These studies evaluate the efficacy and safety of ultrasonic tips in various dental applications.
Reported Outcomes
Published studies report that ultrasonic tips are effective in removing biofilms from long oval canals and dentinal tubules. They also improve surface roughness and reduce bacterial colonization on titanium surfaces. Additionally, diamondlike carbon treatment enhances the fatigue resistance of these tips.
Safety Profile
Reported complications include potential crack formation during root-end preparation, which may lead to bacterial penetration. However, no significant adverse events were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes. Further research is needed to establish long-term outcomes and to compare the efficacy of different ultrasonic tip designs.
Frequently Asked Questions
What are the clinical indications for ultrasonic tips?
Ultrasonic tips are indicated for use in endodontic procedures, including biofilm removal and root-end preparation.
What outcomes have been reported in clinical studies?
Studies have shown effectiveness in biofilm removal, improved surface roughness, and reduced bacterial colonization.
What complications have been reported?
Safety data indicates potential crack formation during root-end preparation, but no major adverse events were reported.
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.