21 CFR 872.4850 — Scaler, Ultrasonic
Dental (DE) · Subpart E—Surgical Devices · § 872.4850
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.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | 2 | 195 | 3rd Party |
