Cleared Traditional

K935139 - FASCINATION CERAMIC BRACKET

K935139 is an FDA 510(k) clearance for FASCINATION CERAMIC BRACKET, manufactured by Dentauraum, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K935139 · Dentauraum, Inc. · Dental device
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Feb 1994
Decision
99d
Days
Class 1
Risk

K935139 is an FDA 510(k) clearance for the FASCINATION CERAMIC BRACKET. Classified as Bracket, Metal, Orthodontic (product code EJF), 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 - K935139

510(k) Number K935139 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.

EJF Device Classification - Class 1, General Controls

Product Code EJF Bracket, Metal, 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.

Regulatory Peers - EJF Bracket, Metal, Orthodontic

All 33
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K935139.
DENTAURUM METAL BRACKETS
K935122 · Dentauraum, Inc. · Jan 1994
ORMCO SPORTSGUARD
K922806 · Ormco Corp. · Oct 1993
PLASTIC CHAIN
K925012 · American Orthodontics · Sep 1993
THE HERBST APPLIANCE
K923405 · Ormco Corp. · May 1993
ORTHODONTIC METAL BRACKET
K923261 · American Orthodontics · Dec 1992
KLEER(TM) ORTHODONTIC BRACKET
K914616 · Ormco Corp. · Nov 1991