21 CFR 872.1740 — Device, Caries Detection
Dental (DE) · Subpart B—Diagnostic Devices · § 872.1740
Identification
The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| LFC | Device, Caries Detection | 2 | 17 | 3rd Party |
| NYH | Plaque Disclosing Kit | 2 | 1 |
