LYNX-SM, SCLAER DENTAL HANDPIECE
Device Facts
| Record ID | K901488 |
|---|---|
| Device Name | LYNX-SM, SCLAER DENTAL HANDPIECE |
| Applicant | Mti Precision Products |
| Product Code | ELC · Dental |
| Decision Date | May 15, 1990 |
| 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.
