21 CFR 868.5820 — Protector, Dental
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5820
Identification
A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BRW | Protector, Dental | 1 | 3 |
