Cleared Traditional

Nanova Sealant

K171330 · Nanova Biomaterials, Inc. · Dental
Sep 2017
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K171330 is an FDA 510(k) clearance for the Nanova Sealant, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on September 8, 2017, 126 days after receiving the submission on May 5, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K171330 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2017
Decision Date September 08, 2017
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBC — Sealant, Pit And Fissure, And Conditioner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3765

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