Core-Flo D/C

FDA 510(k) K093470 · Bisco, Inc.

Substantially Equivalent

510(k) numberK093470

Submission

Device name
Core-Flo D/C
Applicant
Bisco, Inc.
Schaumburg, IL, US
Received
November 6, 2009
Decision date
February 17, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBF – Material, Tooth Shade, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3690
Specialty
Dental

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Questions and answers

When was Core-Flo D/C cleared by the FDA?

Core-Flo D/C (K093470) received a 510(k) decision of Substantially Equivalent on February 17, 2010, 103 days after the submission was received.

What is the product code of K093470?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.