Cleared Traditional

GC TION GINGIVAL PROTECTOR

K043301 · GC America, Inc. · Dental

Jan 2005

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K043301 is an FDA 510(k) clearance for the GC TION GINGIVAL PROTECTOR, a Dam, Rubber (Class I — General Controls, product code EIE), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 25, 2005, 56 days after receiving the submission on November 30, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number	K043301 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2004
Decision Date	January 25, 2005
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement