Cleared Traditional

NPG 2 BASE METAL ALLOY

K892419 · Aalba Dent, Inc. · Dental
Jun 1989
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K892419 is an FDA 510(k) clearance for the NPG 2 BASE METAL ALLOY, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by Aalba Dent, Inc. (Chicago, US). The FDA issued a Cleared decision on June 16, 1989, 67 days after receiving the submission on April 10, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K892419 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1989
Decision Date June 16, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EJF — Bracket, Metal, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410