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FDA 510(k), K080917, IROOT SP
FDA 510(k), K080917, IROOT SP
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$149.00 USD
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510(K) Number: K080917
Device Name: IROOT SP
Manufacturer: INNOVATIVE BIOCERAMIX INC.
Device Classification Name: resin, root canal filling
Regulation Number: 872.3820
Classification Product Code: KIF
Date Received: 04/01/2008
Decision Date: 04/09/2008
Regulation Medical Specialty: Dental
Device Name: IROOT SP
Manufacturer: INNOVATIVE BIOCERAMIX INC.
Device Classification Name: resin, root canal filling
Regulation Number: 872.3820
Classification Product Code: KIF
Date Received: 04/01/2008
Decision Date: 04/09/2008
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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