Cleared Traditional

CERAMAFLEX BRACKET SYSTEM

K950992 · Tp Orthodontics, Inc. · Dental

May 1995

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K950992 is an FDA 510(k) clearance for the CERAMAFLEX BRACKET SYSTEM, a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Tp Orthodontics, Inc. (La Porte, US). The FDA issued a Cleared decision on May 3, 1995, 61 days after receiving the submission on March 3, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K950992 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 1995
Decision Date	May 03, 1995
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

Device Classification

Product Code	NJM — Bracket, Ceramic, Orthodontic
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.5470
Definition	An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.