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
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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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