Solder 650
510(k) K964706
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964706 | Date16 Dec 1996 | 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- Withdrawn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
- EJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3060
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Solder 650 is a noble metal alloy dental device designed for use in fabricating cast or porcelain-fused-to-metal crown and bridge restorations. This alloy is composed primarily of noble metals, including gold, palladium, platinum, or silver, and is intended for dental applications requiring strong, durable bonding in restorative work.
Solder 650 is supplied as a reusable dental alloy and is classified as a Class 2 device under the FDA’s product code EJS. It is intended for use in dental laboratories and offices, where it is melted and applied to join metal components in crown and bridge frameworks. The device is regulated under the FDA’s Traditional 510(k) pathway and holds clearance number K964706, with a decision date of December 16, 1996.