Cleared Traditional

Lucitone Digital Print Denture? System

K243336 · Dentsply Sirona, Inc. · Dental
Dec 2024
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K243336 is an FDA 510(k) clearance for the Lucitone Digital Print Denture? System, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on December 17, 2024, 54 days after receiving the submission on October 24, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K243336 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2024
Decision Date December 17, 2024
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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