Cleared Traditional

DW 272 #1

K003634 · Ivoclar North America, Inc. · Dental
Dec 2000
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K003634 is an FDA 510(k) clearance for the DW 272 #1, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on December 21, 2000, 27 days after receiving the submission on November 24, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K003634 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2000
Decision Date December 21, 2000
Days to Decision 27 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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