21 CFR 872.3810 — Post, Root Canal
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3810
Identification
A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
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 § 872.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ELR | Post, Root Canal | 1 | 35 |
