21 CFR 872.6660 — Powder, Porcelain
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6660
Identification
Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EIH | Powder, Porcelain | 2 | 480 | 3rd Party |
