Cleared Traditional

MESIAL LOOP BAR

K933542 · Gac Intl., Inc. · Dental
Aug 1994
Decision
381d
Days
Class 1
Risk

About This 510(k) Submission

K933542 is an FDA 510(k) clearance for the MESIAL LOOP BAR, a Spring, Orthodontic (Class I — General Controls, product code ECO), submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on August 5, 1994, 381 days after receiving the submission on July 20, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K933542 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1993
Decision Date August 05, 1994
Days to Decision 381 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ECO — Spring, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410