FDA 510(k), K053055, ORTHODONTIC POLYMER COMPOSITE BRACKET

FDA 510(k), K053055, ORTHODONTIC POLYMER COMPOSITE BRACKET

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510(K) Number: K053055
Device Name: ORTHODONTIC POLYMER COMPOSITE BRACKET
Manufacturer: GESTENCO INTERNATIONAL AB
Device Classification Name: bracket, plastic, orthodontic
Regulation Number: 872.5470
Classification Product Code: DYW
Date Received: 10/31/2005
Decision Date: 12/22/2005
Regulation Medical Specialty: Dental

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