Cleared Traditional

K890529 - ALASTIGARD
(FDA 510(k) Clearance)

K890529 · Unitek Corp. · Dental
Mar 1989
Decision
35d
Days
Class 1
Risk

K890529 is an FDA 510(k) clearance for the ALASTIGARD. This device is classified as a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF).

Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on March 9, 1989, 35 days after receiving the submission on February 2, 1989.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K890529 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1989
Decision Date March 09, 1989
Days to Decision 35 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