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FDA 510(k), K162662, GingiDent Gingival Retraction Paste
FDA 510(k), K162662, GingiDent Gingival Retraction Paste
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$149.00 USD
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510(K) Number: K162662
Device Name: GingiDent Gingival Retraction Paste
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Cord, Retraction
Regulation Number:
Classification Product Code: MVL
Date Received: 09/26/2016
Decision Date: 10/20/2017
Regulation Medical Specialty:
Device Name: GingiDent Gingival Retraction Paste
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Cord, Retraction
Regulation Number:
Classification Product Code: MVL
Date Received: 09/26/2016
Decision Date: 10/20/2017
Regulation Medical Specialty:
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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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