21 CFR 872.3840 — Point, Silver, Endodontic
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3840
Identification
An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently the root canal of a tooth.
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 |
|---|---|---|---|---|
| EKL | Point, Silver, Endodontic | 1 | 3 |
