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Jewel Cast Plus

by Pentron Laboratory Technologies

510(k) K023502

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 NumberK023502 Date18 Dec 2002ClearedStatusActive

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  • Withdrawn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
EJH
Device Class
Class II
Regulation
21 CFR Part 872.3710
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

Jewel Cast Plus is a dental alloy classified as a metal base alloy, intended for casting dental restorations. It is designed for use in fabricating crowns, bridges, and substrates for high-expansion low-fusing dental porcelains and indirect composites, providing structural support in fixed prosthodontics.

This device is supplied as a reusable dental casting alloy and is intended for use in dental laboratories. It requires sterilization via standard dental protocols before use and is regulated under FDA 510(k) clearance (K023502) as a Class II dental device under regulation number 872.3710. The product is distributed in premeasured increments for casting applications and adheres to dental industry standards for biocompatibility and mechanical performance.

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