Cleared Traditional

BRIGHT GOLD XH

K041433 · Ivoclar Vivadent, Inc. · Dental
Aug 2004
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K041433 is an FDA 510(k) clearance for the BRIGHT GOLD XH, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on August 19, 2004, 83 days after receiving the submission on May 28, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K041433 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2004
Decision Date August 19, 2004
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060