750 SL Silhouette Line Dental Casting Alloys
510(k) K895060
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895060 | Date19 Dec 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- Withdrawn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 750 SL Silhouette Line Dental Casting Alloys are gold-based noble metal alloys intended for use in dental restorative procedures. These materials are formulated for casting applications to create dental prosthetics.
This device has received FDA 510(k) clearance under the regulation number 872.3060. It is manufactured by Leach and Dillon Co., Inc. and is categorized under the dental medical specialty.
Other devices from Leach and Dillon Co., Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the primary use of the 750 SL Silhouette Line alloys?
These alloys are formulated specifically for casting applications to create dental prosthetics, serving as a material for various dental restorative procedures.
What is the composition of these dental alloys?
The 750 SL Silhouette Line is classified as a gold-based noble metal alloy, which provides the necessary material properties for dental casting.
Has this device received regulatory clearance?
Yes, the 750 SL Silhouette Line Dental Casting Alloys have received FDA 510(k) clearance under regulation number 872.3060.