Cleared Traditional

R&D PROJECT DW271#11A

K002872 · Ivoclar North America, Inc. · Dental
Nov 2000
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K002872 is an FDA 510(k) clearance for the R&D PROJECT DW271#11A, 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 November 2, 2000, 49 days after receiving the submission on September 14, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K002872 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2000
Decision Date November 02, 2000
Days to Decision 49 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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