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DW 277 #4

by Ivoclar North America, Inc.

510(k) K003633

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 NumberK003633 Date20 Dec 2000ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

DW 277 #4 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 supplied as a Class II medical device under FDA 510(k) clearance K003633, with product code EJT and regulation number 872.3060. It was cleared by the FDA on December 20, 2000, following a traditional 510(k) submission, and is classified under the dental specialty with special controls as defined by FDA guidance.

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