Cleared Traditional

K843344 - ACTIVE VERTICAL CORRECTOR ACTIVE BITE

K843344 is an FDA 510(k) clearance for ACTIVE VERTICAL CORRECTOR ACTIVE BITE, manufactured by Active Vertical Correctors, Inc.. The device is a Class 1 Dental device with product code ECO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

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

FDA 510(k) Submission Details - K843344

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
30d faster than avg
Panel avg: 128d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

ECO Device Classification - Class 1, General Controls

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.