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FDA 510(k), K153645, VITA ENAMIC Implant Solutions (IS)
FDA 510(k), K153645, VITA ENAMIC Implant Solutions (IS)
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510(K) Number: K153645
Device Name: VITA ENAMIC Implant Solutions (IS)
Manufacturer: VITA ZAHNFABRIK H. RAUTER GMBH CO.
Device Classification Name: abutment, implant, dental, endosseous
Regulation Number: 872.3630
Classification Product Code: NHA
Date Received: 12/21/2015
Decision Date: 06/30/2016
Regulation Medical Specialty: Dental
Device Name: VITA ENAMIC Implant Solutions (IS)
Manufacturer: VITA ZAHNFABRIK H. RAUTER GMBH CO.
Device Classification Name: abutment, implant, dental, endosseous
Regulation Number: 872.3630
Classification Product Code: NHA
Date Received: 12/21/2015
Decision Date: 06/30/2016
Regulation Medical Specialty: Dental
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- 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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