21 CFR 872.3830 — Point, Paper, Endodontic
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3830
Identification
An endodontic paper point is a device made of paper intended for use during endodontic therapy to dry, or apply medication to, 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 |
|---|---|---|---|---|
| EKN | Point, Paper, Endodontic | 1 | 7 |
