Cleared Traditional

K182422 - Lucitone Denture Base Materials

K182422 is the FDA 510(k) clearance for Lucitone Denture Base Materials by Dentsply Sirona. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K182422 · Dentsply Sirona · Dental device
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Dec 2018
Decision
103d
Days
Class 2
Risk

K182422 is an FDA 510(k) clearance for the Lucitone Denture Base Materials. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on December 18, 2018 after a review of 103 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 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 Dentsply Sirona devices

Submission Details

510(k) Number K182422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2018
Decision Date December 18, 2018
Days to Decision 103 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 127d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 140
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K182422.
Halley resin system
K191427 · Dentsply Sirona · Aug 2019
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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