Cleared Traditional

K844234 - ACTIVE VERTICAL CORRECTOR APPLIANCE
(FDA 510(k) Clearance)

Jan 1985
Decision
64d
Days
Class 1
Risk

K844234 is an FDA 510(k) clearance for the ACTIVE VERTICAL CORRECTOR APPLIANCE. This device is classified as a Spring, Orthodontic (Class I - General Controls, product code ECO).

Submitted by Active Vertical Correctors, Inc. (Fort Wayne, US). The FDA issued a Cleared decision on January 4, 1985, 64 days after receiving the submission on November 1, 1984.

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

Submission Details

510(k) Number K844234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1984
Decision Date January 04, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code ECO — Spring, Orthodontic
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.5410