Cleared Traditional

ALASTIK

K933501 · Unitek Corp. · Dental
Apr 1994
Decision
283d
Days
Class 1
Risk

About This 510(k) Submission

K933501 is an FDA 510(k) clearance for the ALASTIK, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on April 28, 1994, 283 days after receiving the submission on July 19, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K933501 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1993
Decision Date April 28, 1994
Days to Decision 283 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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