ART-M1, MODEL M1-1-ART-A1
Device Facts
| Record ID | K000510 |
|---|---|
| Device Name | ART-M1, MODEL M1-1-ART-A1 |
| Applicant | Bonart Co., Ltd. |
| Product Code | ELC · Dental |
| Decision Date | May 15, 2000 |
| 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.
