Cleared Traditional

K844339 - BRAUN DENTAL CENTER OC-3

K844339 is an FDA 510(k) clearance for BRAUN DENTAL CENTER OC-3, manufactured by The Braun Corp.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K844339 · The Braun Corp. · Dental device
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Feb 1985
Decision
92d
Days
Class 1
Risk

K844339 is an FDA 510(k) clearance for the BRAUN DENTAL CENTER OC-3. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by The Braun Corp. (Boston, US). The FDA issued a Cleared decision on February 8, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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 The Braun Corp. devices

FDA 510(k) Submission Details - K844339

510(k) Number K844339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1984
Decision Date February 08, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 128d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

EFS Device Classification - Class 1, General Controls

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
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.