Dental Porcelain Powder
510(k) K830553
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830553 | Date6 Apr 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Dental Porcelain Powder is a mixture of kaolin, felspar, quartz, or other substances designed for use in prosthetic dentistry. It is intended for the production of artificial teeth in fixed or removable dentures, as well as for the creation of jacket crowns, facings, and veneers.
The powder is processed by heating the mixture to a high temperature in an oven to produce a hard prosthesis. This device has received FDA 510(k) clearance under K830553.
Other devices from Dentsply Intl.
Questions
AI-generated answers, 6 Oct 2026
What is Dental Porcelain Powder used for?
Dental Porcelain Powder is a mixture of kaolin, felspar, quartz, and other substances specifically formulated for use in prosthetic dentistry to create artificial teeth, jacket crowns, facings, and veneers.
How is the powder processed into a finished dental prosthesis?
The powder is designed to be processed by heating the mixture to a high temperature in a specialized oven, which fuses the components to produce a hard, durable dental prosthesis.
What is the regulatory status of this dental material?
This device has received FDA 510(k) clearance under K830553, confirming it has been found substantially equivalent to legally marketed predicate devices.