Cleared Traditional

K834392 - LABIAL CUSPID TUBE
(FDA 510(k) Clearance)

K834392 · Alexotek Co. · Dental

Feb 1984

Decision

76d

Days

Class 1

Risk

K834392 is an FDA 510(k) clearance for the LABIAL CUSPID TUBE. 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 February 28, 1984, 76 days after receiving the submission on December 14, 1983.

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

Submission Details

510(k) Number	K834392 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 1983
Decision Date	February 28, 1984
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—