FDA 510(k), K161598, NobelZygoma 0°
FDA 510(k), K161598, NobelZygoma 0°
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510(K) Number: K161598
Device Name: NobelZygoma 0°
Manufacturer: Nobel Biocare AB
Device Classification Name: implant, endosseous, root-form
Regulation Number: 872.3640
Classification Product Code: DZE
Date Received: 06/09/2016
Decision Date: 03/14/2017
Regulation Medical Specialty: Dental
Device Name: NobelZygoma 0°
Manufacturer: Nobel Biocare AB
Device Classification Name: implant, endosseous, root-form
Regulation Number: 872.3640
Classification Product Code: DZE
Date Received: 06/09/2016
Decision Date: 03/14/2017
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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