Cleared Traditional

FASCINATION CERAMIC BRACKET

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

About This 510(k) Submission

K935139 is an FDA 510(k) clearance for the FASCINATION CERAMIC BRACKET, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on February 4, 1994, 99 days after receiving the submission on October 28, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K935139 FDA.gov
FDA Decision Cleared 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

Device Classification

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