Cleared Traditional

NITANIUM PALATAL EXPANDER

K923218 · Ortho Organizers, Inc. · Dental
Sep 1993
Decision
439d
Days
Class 1
Risk

About This 510(k) Submission

K923218 is an FDA 510(k) clearance for the NITANIUM PALATAL EXPANDER, 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 September 13, 1993, 439 days after receiving the submission on July 1, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K923218 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1992
Decision Date September 13, 1993
Days to Decision 439 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJF — Bracket, Metal, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410