BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS)
Device Facts
| Record ID | K052028 |
|---|---|
| Device Name | BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) |
| Applicant | Bonart Co., Ltd. |
| Product Code | ELC · Dental |
| Decision Date | Oct 28, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4850 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
