ORTHODONTIC POLYMER COMPOSITE BRACKET— 510(k) K053055

Name: FDA 510(k) clearance K053055
Creator: U.S. Food and Drug Administration
Published: 2005-12-22

Substantially Equivalent

Gestenco International AB

FDA 510(k) clearance K053055 for ORTHODONTIC POLYMER COMPOSITE BRACKET, Substantially Equivalent on 2005-12-22. Applicant: Gestenco International AB. Device class: 2.

Clearance details

Applicant: Gestenco International AB
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2005-10-31
Decision date: 2005-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goteborg, SE

Download summary PDF View on FDA.gov ↗

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