DENTAL ULTRASONIC SCALER INSERTS
Device Facts
| Record ID | K953919 |
|---|---|
| Device Name | DENTAL ULTRASONIC SCALER INSERTS |
| Applicant | Hu-Friedy Mfg. Co., Inc. |
| Product Code | ELC · Dental |
| Decision Date | Oct 7, 1995 |
| 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.
