SELECT 20, Dental Alloy
510(k) K903484
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903484 | Date14 Sep 1990 | 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- Withdrawn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, 24 Sep 2026
SELECT 20, Dental Alloy is a noble metal alloy device composed primarily of noble metals such as gold, palladium, platinum, or silver. It is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.
The device is classified as Class II with special controls. It is manufactured by Leach and Dillon Co., Inc. and received FDA 510(k) clearance on September 14, 1990, with the product code EJT and K-number K903484.
Other devices from Leach and Dillon Co., Inc.
Questions
AI-generated answers, 24 Sep 2026
What is SELECT 20 Dental Alloy used for?
SELECT 20 Dental Alloy is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations. It is composed primarily of noble metals such as gold, palladium, platinum, or silver.
Is SELECT 20 Dental Alloy a single-use device?
The device data does not specify whether SELECT 20 Dental Alloy is single-use or reusable. This information would typically be provided in the product's instructions for use or labeling.
What is the regulatory status of SELECT 20 Dental Alloy?
SELECT 20 Dental Alloy is classified as Class II with special controls and received FDA 510(k) clearance on September 14, 1990, with product code EJT and K-number K903484. It is manufactured by Leach and Dillon Co., Inc.
What are the components of SELECT 20 Dental Alloy?
SELECT 20 Dental Alloy is a noble metal alloy device composed primarily of noble metals such as gold, palladium, platinum, or silver. The specific composition percentages are not provided in the device data.