Cleared Traditional

K003632 - DW 273 #1
(FDA 510(k) Clearance)

K003632 · Ivoclar North America, Inc. · Dental
Dec 2000
Decision
26d
Days
Class 2
Risk

K003632 is an FDA 510(k) clearance for the DW 273 #1. This device is classified as 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 December 20, 2000, 26 days after receiving the submission on November 24, 2000.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K003632 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2000
Decision Date December 20, 2000
Days to Decision 26 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