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FDA 510(k), K200330, RC-Prime Root Canal Preparation Cream
FDA 510(k), K200330, RC-Prime Root Canal Preparation Cream
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510(K) Number: K200330
Device Name: RC-Prime Root Canal Preparation Cream
Manufacturer: Pac-Dent, Inc
Device Classification Name: Cleanser, Root Canal
Regulation Number:
Classification Product Code: KJJ
Date Received: 02/10/2020
Decision Date: 07/06/2020
Regulation Medical Specialty:
Device Name: RC-Prime Root Canal Preparation Cream
Manufacturer: Pac-Dent, Inc
Device Classification Name: Cleanser, Root Canal
Regulation Number:
Classification Product Code: KJJ
Date Received: 02/10/2020
Decision Date: 07/06/2020
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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