Cleared Traditional

ION-IMPLANTED NEO SENTALLOY

K932025 · Gac Intl., Inc. · Dental

Sep 1993

Decision

140d

Days

Class 1

Risk

About This 510(k) Submission

K932025 is an FDA 510(k) clearance for the ION-IMPLANTED NEO SENTALLOY, 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 13, 1993, 140 days after receiving the submission on April 26, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number	K932025 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 1993
Decision Date	September 13, 1993
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement