Cleared Traditional

DENTAURUM STAINLESS STEEL TUBING (K935143) - FDA 510(k) Clearance

Class I Dental device.

K935143 · Dentauraum, Inc. · Dental device
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Jan 1994
Decision
95d
Days
Class 1
Risk

K935143 is an FDA 510(k) clearance for the DENTAURUM STAINLESS STEEL TUBING. Classified as Tube, Orthodontic (product code DZD), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 95 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 Dentauraum, Inc. devices

Submission Details

510(k) Number K935143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date January 31, 1994
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZD Tube, 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.