đź“‹ FDA Reference
Tun R Ultrasonic TIPS Product Family
Engineered Endodontics
Summary: The tun r ultrasonic tips are specialized dental instruments used in endodontic procedures to enhance cleaning and shaping of root canals. They are primarily used by endodontists and dental professionals.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K182145 ↗
Decision Date ?
June 7, 2019
Product Code ?
ELC
Device Class ?
Class 2
Evidence ?
0 studies
The tun r ultrasonic tips were cleared through the FDA 510(k) pathway on June 7, 2019. Manufactured by Engineered Endodontics, this device is classified as Class 2 under product code ELC.
What It Is
The tun r ultrasonic tips are precision instruments designed for use in endodontic procedures. They utilize ultrasonic energy to improve the cleaning and shaping of root canals, enhancing the removal of debris and bacteria. The tips are engineered to work with ultrasonic handpieces, providing clinicians with improved access and efficiency during root canal therapy.
FDA-Cleared Indications
- Use in endodontic procedures for cleaning and shaping root canals.
- Use with a compatible ultrasonic handpiece during root canal therapy.
Clinical Applications
- Ultrasonic cleaning of root canals during endodontic treatment.
- Ultrasonic shaping or refinement of root canal spaces.
- Removal of debris during root canal procedures.
- Endodontic treatment in canals requiring ultrasonic instrumentation.
Practical Considerations
- Confirm that the tip is compatible with the clinician's ultrasonic handpiece before use.
- Select the appropriate tip size and configuration for the root canal anatomy and planned procedure.
- Use appropriate ultrasonic endodontic technique and follow the manufacturer's instructions for handling, power settings, cleaning, and sterilization.
- The FDA record identifies these as dental instruments; MRI safety should be determined from the specific tip's materials and labeling rather than assumed.
- Use is limited by the patient's dental anatomy, canal condition, and the clinician's assessment of whether ultrasonic instrumentation is appropriate.
Frequently Asked Questions
What is tun r ultrasonic tips used for?
They are used for cleaning and shaping root canals during endodontic procedures.
What specialties typically use this device?
Endodontists and dental professionals specializing in root canal therapy.
What are the FDA-cleared indications?
For use in dental procedures involving the cleaning and shaping of root canals.
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.