Cleared Traditional

K920850 - GAC THUMB-SUCKING CONTROL APPLIANCE
(FDA 510(k) Clearance)

K920850 · Gac Intl., Inc. · Dental device

Aug 1992

Decision

181d

Days

Class 1

Risk

K920850 is an FDA 510(k) clearance for the GAC THUMB-SUCKING CONTROL APPLIANCE. This device is classified as a Wire, Orthodontic (Class I - General Controls, product code DZC).

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on August 24, 1992, 181 days after receiving the submission on February 25, 1992.

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

Submission Details

510(k) Number	K920850 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 25, 1992
Decision Date	August 24, 1992
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement