Cleared Traditional

Nanova Universal Composite

K152004 · Nanova Biomaterials, Inc. · Dental
Nov 2015
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K152004 is an FDA 510(k) clearance for the Nanova Universal Composite, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on November 17, 2015, 120 days after receiving the submission on July 20, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K152004 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2015
Decision Date November 17, 2015
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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