21 CFR 872.4840 — Scaler, Rotary
Dental (DE) · Subpart E—Surgical Devices · § 872.4840
Identification
A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ELB | Scaler, Rotary | 2 | 6 | 3rd Party |