Cleared Traditional

UNI-STICK PLASTIC LIGATURE, MODIFIED

K926578 · American Orthodontics · Dental
Mar 1993
Decision
191d
Days
Class 1
Risk

About This 510(k) Submission

K926578 is an FDA 510(k) clearance for the UNI-STICK PLASTIC LIGATURE, MODIFIED, a Band, Elastic, Orthodontic (Class I — General Controls, product code ECI), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on March 31, 1993, 191 days after receiving the submission on September 21, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K926578 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1992
Decision Date March 31, 1993
Days to Decision 191 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ECI — Band, Elastic, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410

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