Cleared Traditional

ORTHODONITC METAL REINFORCED PLASTIC BRACKET

K942826 · Gac Intl., Inc. · Dental
Dec 1994
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K942826 is an FDA 510(k) clearance for the ORTHODONITC METAL REINFORCED PLASTIC BRACKET, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on December 14, 1994, 183 days after receiving the submission on June 14, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K942826 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1994
Decision Date December 14, 1994
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DYW — Bracket, Plastic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470

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