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450 SL (SILHOUETTE LINE) Dental Casting Alloys

by Leach and Dillon Co., Inc.

510(k) K895063

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 NumberK895063 Date19 Dec 1989ClearedStatusActive

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  • Withdrawn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, 28 Sep 2026

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

450 SL (SILHOUETTE LINE) Dental Casting Alloys are gold-based noble metal alloys used for dental casting applications. These alloys are designed for use in dental prosthetics and restorations, meeting the standards of BS EN ISO 22674 and BS EN ISO 9693.

The device is supplied as dental casting materials and is intended for use in dental laboratories. It is a Class II device cleared by the FDA under 510(k) K895063, with the product code EJT and regulation number 872.3060. The device is manufactured by Leach and Dillon Co., Inc. in Mansfield, MA.

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