Lucitone Digital Print Denture System
K-Number: K231578 · 2023-10-20
ApplicantDentsply Sirona
Decision Date2023-10-20
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Lucitone Digital Print Denture System is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2023-10-20 under approval number K231578. 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 2023-10-20. It is manufactured by Dentsply Sirona. The 510(k) number is K231578.
When was Lucitone Digital Print Denture System approved by the FDA?
Lucitone Digital Print Denture System received FDA 510(k) clearance on 2023-10-20, under approval number K231578.
What company makes Lucitone Digital Print Denture System?
Lucitone Digital Print Denture System is manufactured by Dentsply Sirona.
What is the FDA product code for Lucitone Digital Print Denture System?
The FDA product code for Lucitone Digital Print Denture System is EBI.
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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.