PREMIER ULTRASONIC SCALER AND INSERTS
Device Facts
| Record ID | K010195 |
|---|---|
| Device Name | PREMIER ULTRASONIC SCALER AND INSERTS |
| Applicant | Premier Dental Products Co. |
| Product Code | ELC · Dental |
| Decision Date | Apr 17, 2001 |
| 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.
