GC TION GINGIVAL PROTECTOR— 510(k) K043301

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K043301 for GC TION GINGIVAL PROTECTOR, Substantially Equivalent on 2005-01-25. Applicant: GC America, Inc.. Device class: 1.

Clearance details

Applicant: GC America, Inc.
Product code: Code EIE
Device class: Class 1
Regulation: 21 CFR 872.6300
Advisory panel: Dental
Date received: 2004-11-30
Decision date: 2005-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

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