Cleared Traditional

K162572 - NextDent Denture

K162572 is an FDA 510(k) clearance for NextDent Denture, manufactured by Vertex-Dental B.V.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K162572 · Vertex-Dental B.V. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
288d
Days
Class 2
Risk

K162572 is an FDA 510(k) clearance for the NextDent Denture, E-Denture. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Vertex-Dental B.V. (Zeist, NL). The FDA issued a Cleared decision on June 30, 2017 after a review of 288 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Vertex-Dental B.V. devices

FDA 510(k) Submission Details - K162572

510(k) Number K162572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2016
Decision Date June 30, 2017
Days to Decision 288 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
161d slower than avg
Panel avg: 127d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 157
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K162572.
Juell 3D Volo Base
K181220 · Park Dental Research Corporation · Oct 2018
Keymill
K172764 · Mycone Dental Supply Company, Inc. (Aka Keystone Industries) · Apr 2018
Yamahachi Pink CAD/CAM Disk
K172683 · YAMAHACHI DENTAL MFG., Co. · Jan 2018
Pour Acrylic
K161330 · Dentsply Sirona · Oct 2016
GC Reline II
K153253 · GC America, Inc. · Mar 2016
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID
K151142 · Wieland Dental + Technik GmbH & Co. KG · Aug 2015