Cleared Traditional

K844034 - SONOCARE (FDA 510(k) Clearance)

Class I Dental device.

K844034 · Echo Ultrasound · Dental device
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Jan 1985
Decision
99d
Days
Class 1
Risk

K844034 is an FDA 510(k) clearance for the SONOCARE. Classified as Band, Material, Orthodontic (product code DYO), Class I - General Controls.

Submitted by Echo Ultrasound (Lewistown, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 99 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 Echo Ultrasound devices

Submission Details

510(k) Number K844034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1984
Decision Date January 23, 1985
Days to Decision 99 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 127d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DYO Band, Material, 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.