Cleared Traditional

R&D PROJECT DW269#25

K001469 · Ivoclar North America, Inc. · Dental
Jul 2000
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K001469 is an FDA 510(k) clearance for the R&D PROJECT DW269#25, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on July 5, 2000, 56 days after receiving the submission on May 10, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K001469 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2000
Decision Date July 05, 2000
Days to Decision 56 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