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FDA 510(k), K130672, OPTIFLOW II FLOWABLE COMPOSITE, LC
FDA 510(k), K130672, OPTIFLOW II FLOWABLE COMPOSITE, LC
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510(K) Number: K130672
Device Name: OPTIFLOW II FLOWABLE COMPOSITE, LC
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Material, Tooth Shade, Resin
Regulation Number: 872.3690
Classification Product Code: EBF
Date Received: 03/12/2013
Decision Date: 08/13/2013
Regulation Medical Specialty: Dental
Device Name: OPTIFLOW II FLOWABLE COMPOSITE, LC
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Material, Tooth Shade, Resin
Regulation Number: 872.3690
Classification Product Code: EBF
Date Received: 03/12/2013
Decision Date: 08/13/2013
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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