Cleared Traditional

PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER

K904128 · American Orthodontics · Dental
Nov 1990
Decision
65d
Days
Class 1
Risk

About This 510(k) Submission

K904128 is an FDA 510(k) clearance for the PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER, a Positioner, Tooth, Preformed (Class I — General Controls, product code KMY), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on November 9, 1990, 65 days after receiving the submission on September 5, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.5525.

Submission Details

510(k) Number K904128 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1990
Decision Date November 09, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code KMY — Positioner, Tooth, Preformed
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5525