đź“‹ FDA Reference
Bonart Model Art-P6 Piezo Electric Ultrasonic Scaler Accessories TIPS
Bonart
Summary: The Bonart Model ART-P6 is a piezoelectric ultrasonic scaler used primarily in dental practices for scaling and root planing. It is utilized by dental professionals to remove calculus deposits and plaque from teeth.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K071981 ↗
Decision Date ?
October 26, 2007
Product Code ?
ELC
Device Class ?
Class 2
Evidence ?
0 studies
The Bonart Model ART-P6 was cleared through the FDA 510k pathway on October 26, 2007. Manufactured by Bonart, it is classified as a Class 2 device under the product code ELC.
What It Is
The Bonart Model ART-P6 is a piezoelectric ultrasonic scaler designed for dental procedures. It uses ultrasonic vibrations to efficiently remove calculus and plaque from teeth surfaces. The device operates with a range of interchangeable tips, allowing for precision in various dental cleaning tasks.
FDA-Cleared Indications
- Removal of plaque and calculus during dental procedures.
- Use in dental cleaning and periodontal maintenance.
Clinical Applications
- Routine dental cleaning to remove plaque and calculus from tooth surfaces.
- Scaling procedures for calculus removal.
- Root planing as part of periodontal treatment.
- Periodontal maintenance for patients with periodontal disease.
Practical Considerations
- The scaler is intended for use by trained dental professionals, such as dentists and dental hygienists.
- Interchangeable tips should be selected according to the dental procedure and used according to the manufacturer’s instructions.
- Use a controlled, consistent motion and appropriate technique to reduce the risk of tooth-surface or soft-tissue injury.
- The record describes a dental ultrasonic scaler and does not establish MRI safety; MRI compatibility should be confirmed with the manufacturer before the device or accessories enter an MRI environment.
- The FDA record identifies the device as a Class II device cleared through the 510(k) pathway under product code ELC.
Frequently Asked Questions
What is the Bonart Model ART-P6 Piezo Electric Ultrasonic Scaler used for?
It is used for removing calculus and plaque from teeth during dental cleaning and periodontal procedures.
What specialties typically use this device?
This device is primarily used by dental professionals, including dentists and dental hygienists.
What are the FDA-cleared indications?
The device is cleared for use in dental procedures to remove plaque and calculus 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.