Cleared Traditional

DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID

K121880 · Danville Materials, Inc. · Dental
Sep 2012
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K121880 is an FDA 510(k) clearance for the DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Danville Materials, Inc. (San Ramon, US). The FDA issued a Cleared decision on September 25, 2012, 89 days after receiving the submission on June 28, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K121880 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2012
Decision Date September 25, 2012
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690