Partial Denture Alloy
by Dentsply Intl. 510(k)
Active
510(k) K833512
Overview
The Partial Denture Alloy is a base metal alloy intended for use in the fabrication of dental prosthetics. It serves as a material component for creating partial dentures within a dental laboratory setting.
This device is supplied by Dentsply Intl. and is subject to FDA 510(k) clearance under regulation number 872.3710. It is classified as a Class II medical device under product code EJH.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833512 | Date27 Dec 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- EJH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3710
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dentsply Intl.
Questions
What is the intended use of the Partial Denture Alloy?
This device is a base metal alloy specifically intended for use in the fabrication of dental prosthetics. It serves as a material component for creating partial dentures within a dental laboratory environment.
How is this device regulated?
The Partial Denture Alloy is subject to FDA 510(k) clearance under regulation number 872.3710. It is classified as a Class II medical device under product code EJH.
Who is the manufacturer of this alloy?
This device is supplied by Dentsply Intl., which is the applicant of record for the 510(k) clearance.