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FDA 510(k), K160248, ArgenIS Titanium Abutments
FDA 510(k), K160248, ArgenIS Titanium Abutments
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510(K) Number: K160248
Device Name: ArgenIS Titanium Abutments
Manufacturer: Argen Corporation
Device Classification Name: abutment, implant, dental, endosseous
Regulation Number: 872.3630
Classification Product Code: NHA
Date Received: 02/01/2016
Decision Date: 08/05/2016
Regulation Medical Specialty: Dental
Device Name: ArgenIS Titanium Abutments
Manufacturer: Argen Corporation
Device Classification Name: abutment, implant, dental, endosseous
Regulation Number: 872.3630
Classification Product Code: NHA
Date Received: 02/01/2016
Decision Date: 08/05/2016
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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