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FDA 510(k), K063422, BIOAGGREGATE
FDA 510(k), K063422, BIOAGGREGATE
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510(K) Number: K063422
Device Name: BIOAGGREGATE
Manufacturer: INNOVATIVE BIOCERAMIX INC.
Device Classification Name: resin, root canal filling
Regulation Number: 872.3820
Classification Product Code: KIF
Date Received: 11/13/2006
Decision Date: 11/21/2006
Regulation Medical Specialty: Dental
Device Name: BIOAGGREGATE
Manufacturer: INNOVATIVE BIOCERAMIX INC.
Device Classification Name: resin, root canal filling
Regulation Number: 872.3820
Classification Product Code: KIF
Date Received: 11/13/2006
Decision Date: 11/21/2006
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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