Cleared Traditional

K931663 - NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL
(FDA 510(k) Clearance)

K931663 · Ortho Organizers, Inc. · Dental device

Jul 1993

Decision

94d

Days

Class 1

Risk

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

Submitted by Ortho Organizers, Inc. (San Marcos, US). The FDA issued a Cleared decision on July 8, 1993, 94 days after receiving the submission on April 5, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.

Submission Details

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