21 CFR 882.5070 — Block, Bite
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5070
Identification
A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JXL | Block, Bite | 2 | 28 | 3rd Party |
