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sonicflex 2003 and sonicflex lux 2003 l with instrument tips
Sybron Dental Specialties
Summary: The Sonicflex 2003 and Sonicflex Lux 2003 L are dental devices used primarily for scaling and cleaning teeth. They are typically used by dental professionals in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K080089 ↗
Decision Date
September 4, 2008
Product Code
ELC
Device Class
Class 2
Evidence
0 studies
The Sonicflex 2003 and Lux 2003 L were cleared through the FDA 510(k) pathway on September 4, 2008. Manufactured by Sybron Dental Specialties, these devices are classified as Class 2 under product code ELC.
What It Is
The Sonicflex 2003 and Sonicflex Lux 2003 L are ultrasonic dental instruments designed for scaling and cleaning teeth. They operate by using high-frequency vibrations to remove plaque and calculus from the teeth surfaces. These devices are equipped with interchangeable instrument tips, allowing for versatility in dental procedures.
Clinical Applications
These devices are commonly used in dental practices for routine cleanings and periodontal therapy. They are particularly useful in removing hard deposits and stains from teeth, making them essential tools in preventive dental care. Dental hygienists and dentists use these devices in both general and specialized dental clinics.
Indications for Use
The FDA-cleared indications suggest these devices are intended for dental cleaning and scaling procedures. They are suitable for patients requiring removal of plaque, calculus, and stains from teeth surfaces.
Practical Considerations
The Sonicflex devices come with various instrument tips, allowing customization based on the procedure. They are compatible with standard dental units and require proper technique to ensure patient comfort and effective cleaning.
Frequently Asked Questions
What is Sonicflex 2003 used for?
The Sonicflex 2003 is used for dental scaling and cleaning, helping to remove plaque and calculus from teeth.
What specialties typically use this device?
This device is typically used by general dentists and dental hygienists in both general and specialized dental practices.
What are the FDA-cleared indications?
The device is indicated for dental cleaning and scaling procedures, suitable for removing plaque, calculus, and stains 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.