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FDA 510(k), K141422, PROFLUORO FLUORIDE VARNISH
FDA 510(k), K141422, PROFLUORO FLUORIDE VARNISH
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510(K) Number: K141422
Device Name: PROFLUORO FLUORIDE VARNISH
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Varnish, Cavity
Regulation Number: 872.3260
Classification Product Code: LBH
Date Received: 05/30/2014
Decision Date: 09/30/2014
Regulation Medical Specialty: Dental
Device Name: PROFLUORO FLUORIDE VARNISH
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Varnish, Cavity
Regulation Number: 872.3260
Classification Product Code: LBH
Date Received: 05/30/2014
Decision Date: 09/30/2014
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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