Cleared Traditional

K935154 - DENTAURUM EXPANSION SCREWS

K935154 is an FDA 510(k) clearance for DENTAURUM EXPANSION SCREWS, manufactured by Dentauraum, Inc.. The device is a Class 1 Dental device with product code DYJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K935154 · Dentauraum, Inc. · Dental device
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Feb 1994
Decision
98d
Days
Class 1
Risk

K935154 is an FDA 510(k) clearance for the DENTAURUM EXPANSION SCREWS. Classified as Retainer, Screw Expansion, Orthodontic (product code DYJ), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on February 3, 1994 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 Dentauraum, Inc. devices

FDA 510(k) Submission Details - K935154

510(k) Number K935154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date February 03, 1994
Days to Decision 98 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

DYJ Device Classification - Class 1, General Controls

Product Code DYJ Retainer, Screw Expansion, 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.