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FDA 510(k), K130991, NEXXZR(TM)T AND NEXXZR(TM)S
FDA 510(k), K130991, NEXXZR(TM)T AND NEXXZR(TM)S
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510(K) Number: K130991
Device Name: NEXXZR(TM)T AND NEXXZR(TM)S
Manufacturer: SAGEMAX BIOCERAMICS, INC.
Device Classification Name: powder, porcelain
Regulation Number: 872.6660
Classification Product Code: EIH
Date Received: 04/10/2013
Decision Date: 02/10/2014
Regulation Medical Specialty: Dental
Device Name: NEXXZR(TM)T AND NEXXZR(TM)S
Manufacturer: SAGEMAX BIOCERAMICS, INC.
Device Classification Name: powder, porcelain
Regulation Number: 872.6660
Classification Product Code: EIH
Date Received: 04/10/2013
Decision Date: 02/10/2014
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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