Cleared Traditional

PLASTIC CHAIN

K925012 · American Orthodontics · Dental
Sep 1993
Decision
346d
Days
Class 1
Risk

About This 510(k) Submission

K925012 is an FDA 510(k) clearance for the PLASTIC CHAIN, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on September 13, 1993, 346 days after receiving the submission on October 2, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K925012 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 1992
Decision Date September 13, 1993
Days to Decision 346 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