Cleared Abbreviated

K191497 - NextDent Denture 3D+ (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K191497 · Vertex-Dental B.V. · Dental device
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Nov 2019
Decision
149d
Days
Class 2
Risk

K191497 is an FDA 510(k) clearance for the NextDent Denture 3D+. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Vertex-Dental B.V. (Soesterberg, NL). The FDA issued a Cleared decision on November 1, 2019 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vertex-Dental B.V. devices

Submission Details

510(k) Number K191497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2019
Decision Date November 01, 2019
Days to Decision 149 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 327
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K191497.
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