Cleared Traditional

K935144 - DENTAURUM OLYMPIA LATEX-ELASTICS AND DE...

K935144 is an FDA 510(k) clearance for DENTAURUM OLYMPIA LATEX-ELASTICS AND DE..., manufactured by Dentauraum, Inc.. The device is a Class 1 Dental device with product code ECI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K935144 · Dentauraum, Inc. · Dental device
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Feb 1994
Decision
99d
Days
Class 1
Risk

K935144 is an FDA 510(k) clearance for the DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on February 4, 1994 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 Dentauraum, Inc. devices

FDA 510(k) Submission Details - K935144

510(k) Number K935144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date February 04, 1994
Days to Decision 99 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
28d faster than avg
Panel avg: 127d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

ECI Device Classification - Class 1, General Controls

Product Code ECI Band, Elastic, 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.