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SELECT 20, Dental Alloy

by Leach and Dillon Co., Inc.

510(k) K903484

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903484 Date14 Sep 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

See all devices from Leach and Dillon Co., Inc. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.