Cleared Traditional

ACTIVE VERTICAL CORRECTOR ACTIVE BITE (K843344) - FDA 510(k) Clearance

Class I Dental device.

K843344 · Active Vertical Correctors, Inc. · Dental device
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Dec 1984
Decision
98d
Days
Class 1
Risk

K843344 is an FDA 510(k) clearance for the ACTIVE VERTICAL CORRECTOR ACTIVE BITE. Classified as Spring, Orthodontic (product code ECO), Class I - General Controls.

Submitted by Active Vertical Correctors, Inc. (Fort Wayne, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Active Vertical Correctors, Inc. devices

Submission Details

510(k) Number K843344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date December 03, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECO Spring, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.