Cleared Traditional

BONDABLE RETAINER AND SPACE MAINTAINER

K893483 · American Orthodontics · Dental
Jul 1989
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K893483 is an FDA 510(k) clearance for the BONDABLE RETAINER AND SPACE MAINTAINER, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on July 14, 1989, 71 days after receiving the submission on May 4, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K893483 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1989
Decision Date July 14, 1989
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

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