Class of Casting Alloys Type III or Alt
by Howmedica Corp. 510(k)
Active
510(k) K820434
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820434 | Date11 Mar 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- EJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
This device is a class of casting alloys type III or alt, which falls under the device type 'Alloy, Other Noble Metal' as defined in the nomenclature authority. It is a dental alloy used in the fabrication of dental restorations.
It is supplied as a reusable material for dental casting procedures, intended for use in dental settings. The device has received FDA 510(k) clearance (K820434) and is classified as a Class II medical device under regulation number 872.3060, with product code EJS.
Other devices from Howmedica Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the CLASS OF CASTING ALLOYS TYPE III OR ALT used for?
This device is a dental alloy used in the fabrication of dental restorations, intended for use in dental casting procedures within dental settings.
How is the CLASS OF CASTING ALLOYS TYPE III OR ALT supplied and is it reusable?
The device is supplied as a reusable material for dental casting procedures, meaning it can be used multiple times in the fabrication of dental restorations.
What regulatory clearance does the CLASS OF CASTING ALLOYS TYPE III OR ALT have?
The device has received FDA 510(k) clearance under submission number K820434 and is classified as a Class II medical device under regulation 872.3060 with product code EJS.