21 CFR 872.3250 — Liner, Cavity, Calcium Hydroxide
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3250
Identification
A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | 2 | 77 | 3rd Party |