510(k) K121880

DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID by Danville Materials, Inc. — Product Code EBF

K121880 is an FDA 510(k) premarket notification submitted by Danville Materials, Inc. for the device "DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID". The FDA issued a decision of Substantially Equivalent on September 25, 2012. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Danville Materials, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2012
Date Received
June 28, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type