Cleared Traditional

K923029 - ORTHODONTIC STAINLESS STEEL BRACKET
(FDA 510(k) Clearance)

K923029 · Gac Intl., Inc. · Dental device

Sep 1992

Decision

97d

Days

Class 1

Risk

K923029 is an FDA 510(k) clearance for the ORTHODONTIC STAINLESS STEEL BRACKET. This device is classified as a Bracket, Metal, Orthodontic (Class I - General Controls, product code EJF).

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on September 28, 1992, 97 days after receiving the submission on June 23, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number	K923029 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 1992
Decision Date	September 28, 1992
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement