Lucitone Digital Print Denture System
K-Number: K243336 · 2024-12-17
ApplicantDentsply Sirona, Inc.
Decision Date2024-12-17
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Lucitone Digital Print Denture System is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2024-12-17 under approval number K243336. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lucitone Digital Print Denture System?
Lucitone Digital Print Denture System is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K243336.
When was Lucitone Digital Print Denture System approved by the FDA?
Lucitone Digital Print Denture System received FDA 510(k) clearance on 2024-12-17, under approval number K243336.
What company makes Lucitone Digital Print Denture System?
Lucitone Digital Print Denture System is manufactured by Dentsply Sirona, Inc..
What is the FDA product code for Lucitone Digital Print Denture System?
The FDA product code for Lucitone Digital Print Denture System is EBI.
Related Clinical Trials
NCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
ACTIVE_NOT_RECRUITING
NCT07557147
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
NOT_YET_RECRUITING
NCT07586163
Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency
ACTIVE_NOT_RECRUITING
NCT07585162
PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures
NOT_YET_RECRUITING
NCT07578142
AcceXible Speech-Based Screening for Depression and Anxiety in University Students (UAQ, Mexico)
NOT_YET_RECRUITING
NCT07578155
Validation of Accexible Screening and Self-Administered Activities for Emotional Well-Being in a University Hospital (UaDEC)
COMPLETED
Related PubMed Literature
PMID: 41734979
Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review.
Yonsei medical journal (2026)
PMID: 41491965
From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum.
Current opinion in nephrology and hypertension (2026)
PMID: 40942702
Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health.
Sensors (Basel, Switzerland) (2025)
PMID: 40845310
Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification?
JMIR mHealth and uHealth (2025)
Other Devices by Dentsply Sirona, Inc.
Related Devices (Code: EBI)
K161330Pour AcrylicDentsply Sirona
K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry
K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc.
K160498Dentivera Milling DiscDental Solutions, LLC
K153590AvaDent Denture Base MaterialGlobal Dental Science
K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.