High Noble, Type Iii Dental Casting Alloy
by Jelenko Co.
510(k) K893688
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893688 | Date23 Aug 1989 | 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- Withdrawn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
- EJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The High Noble, Type Iii Dental Casting Alloy is a dental casting alloy, composed primarily of noble metal, used in dental applications. It is classified as a Type III alloy. The device is made by Jelenko Co.
The alloy is supplied as a substantially equivalent device, with an FDA 510K clearance. It is regulated under regulation number 872.3060 and has a product code of EJT. The device is used in the dental medical specialty and is classified as a device class 2.
Other devices from Jelenko Co.
Questions
AI-generated answers, 21 Sep 2026
What is the High Noble Type III Dental Casting Alloy used for?
The High Noble Type III Dental Casting Alloy is used in dental applications, specifically for creating dental castings.
What is the composition of the High Noble Type III Dental Casting Alloy?
The alloy is composed primarily of noble metal.
Is the High Noble Type III Dental Casting Alloy regulated by the FDA?
Yes, the device has FDA 510K clearance and is regulated under regulation number 872.3060.
What is the product code for the High Noble Type III Dental Casting Alloy?
The product code for the High Noble Type III Dental Casting Alloy is EJT.