Cleared Traditional

K171330 - Nanova Sealant

K171330 is an FDA 510(k) clearance for Nanova Sealant, manufactured by Nanova Biomaterials, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

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

K171330 is an FDA 510(k) clearance for the Nanova Sealant. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on September 8, 2017 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nanova Biomaterials, Inc. devices

FDA 510(k) Submission Details - K171330

510(k) Number K171330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBC Sealant, Pit And Fissure, And Conditioner

All 86
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K171330.
BA Pit & Fissure Sealant
K190998 · Apex Dental Materials, Inc. · Nov 2019
Helioseal F Plus
K190339 · Ivoclar Vivadent, AG · Jul 2019
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018
HAPI Seal
K162598 · Bisco, Inc. · May 2017
CONTROL SEAL
K130485 · Voco GmbH · Feb 2014
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K113818 · Pulpdent Corporation · Mar 2012