ORTHODONTIC POLYMER COMPOSITE BRACKET— 510(k) K053055

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.

Clearance details

Applicant: Gestenco International AB
Product code: Code DYW
Advisory panel: Dental
Date received: 2005-10-31
Decision date: 2005-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goteborg, SE

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