Cleared Traditional

K931663 - NITANIUM PRO FORM ARCHWIRES

K931663 is an FDA 510(k) clearance for NITANIUM PRO FORM ARCHWIRES, manufactured by Ortho Organizers, Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K931663 · Ortho Organizers, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
94d
Days
Class 1
Risk

K931663 is an FDA 510(k) clearance for the NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Ortho Organizers, Inc. (San Marcos, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 94 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 Ortho Organizers, Inc. devices

FDA 510(k) Submission Details - K931663

510(k) Number K931663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date July 08, 1993
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
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 35
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K931663.
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