Cleared Traditional

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel

K172977 · Nanova Biomaterials, Inc. · Dental
Jan 2018
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K172977 is an FDA 510(k) clearance for the Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on January 16, 2018, 111 days after receiving the submission on September 27, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K172977 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2017
Decision Date January 16, 2018
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200