đź“‹ FDA Reference
Symmetry S-Series Piezoelectric Scaling TIPS
Hu-Friedy Mfg.
Summary: The symmetry s-series piezoelectric scaling tips are dental instruments used for ultrasonic scaling procedures. They are primarily used by dental professionals for removing plaque and calculus from teeth.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K053178 ↗
Decision Date ?
February 1, 2006
Product Code ?
ELC
Device Class ?
Class 2
Evidence ?
0 studies
The symmetry s-series piezoelectric scaling tips were cleared through the FDA 510(k) pathway on February 1, 2006. Manufactured by Hu-Friedy Mfg., this device is classified as a Class 2 medical device under product code ELC.
What It Is
The symmetry s-series piezoelectric scaling tips are specialized dental tools designed for ultrasonic scaling. They utilize piezoelectric technology to produce high-frequency vibrations that effectively remove plaque and calculus from tooth surfaces. These tips are compatible with piezoelectric ultrasonic scalers, offering precision and efficiency in dental hygiene procedures.
FDA-Cleared Indications
- For ultrasonic dental scaling procedures.
- For removing plaque and calculus from tooth surfaces.
- For use with compatible piezoelectric ultrasonic scaling handpieces.
Clinical Applications
- Removal of plaque and calculus during routine dental cleaning.
- Removal of hard deposits during periodontal scaling procedures.
- Dental scaling in general dentistry and periodontal care when indicated by the treating dental professional.
Practical Considerations
- The tips must be used with a compatible piezoelectric ultrasonic scaler and properly attached according to the manufacturer's instructions.
- Different tip sizes and designs may be selected for specific tooth surfaces, deposits, and access requirements.
- The operator should use the recommended angle, pressure, power setting, and water flow to limit unnecessary heat or damage to tooth surfaces and periodontal tissues.
- These are dental instruments, not intravascular or surgical devices, and they are not intended for interventional radiology or vascular procedures.
- MRI safety depends on the specific tip, handpiece, and material configuration; users should consult the current manufacturer labeling rather than assume the device is MRI safe.
Frequently Asked Questions
What is symmetry s-series piezoelectric scaling tips used for?
These tips are used for ultrasonic scaling to remove plaque and calculus from teeth.
What specialties typically use this device?
This device is typically used by dental professionals, including general dentists and periodontists.
What are the FDA-cleared indications?
The device is indicated for use in dental scaling procedures to remove plaque and tartar from teeth.
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.