Cleared Traditional

DENTAURUM SPACE MAINTAINER (K935856) - FDA 510(k) Clearance

Class I Dental device.

K935856 · Dentauraum, Inc. · Dental device
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Apr 1994
Decision
141d
Days
Class 1
Risk

K935856 is an FDA 510(k) clearance for the DENTAURUM SPACE MAINTAINER. Classified as Maintainer, Space Preformed, Orthodontic (product code DYT), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5525 - 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 K935856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1993
Decision Date April 28, 1994
Days to Decision 141 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
14d slower than avg
Panel avg: 127d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DYT Maintainer, Space Preformed, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5525
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.