FDA 510(k), K152385, Zeramex P6 Dental Implant System
FDA 510(k), K152385, Zeramex P6 Dental Implant System
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510(K) Number: K152385
Device Name: Zeramex P6 Dental Implant System
Manufacturer: DENTALPOINT AG
Device Classification Name: implant, endosseous, root-form
Regulation Number: 872.3640
Classification Product Code: DZE
Date Received: 08/24/2015
Decision Date: 07/27/2016
Regulation Medical Specialty: Dental
Device Name: Zeramex P6 Dental Implant System
Manufacturer: DENTALPOINT AG
Device Classification Name: implant, endosseous, root-form
Regulation Number: 872.3640
Classification Product Code: DZE
Date Received: 08/24/2015
Decision Date: 07/27/2016
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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