Cleared Traditional

K834446 - ALEXOTEK LINGUAL TUBES
(FDA 510(k) Clearance)

K834446 · Alexotek Co. · Dental

Apr 1984

Decision

111d

Days

Class 1

Risk

K834446 is an FDA 510(k) clearance for the ALEXOTEK LINGUAL TUBES. This device is classified as a Tube, Orthodontic (Class I — General Controls, product code DZD).

Submitted by Alexotek Co. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984, 111 days after receiving the submission on December 16, 1983.

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

Submission Details

510(k) Number	K834446 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 1983
Decision Date	April 05, 1984
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—