Lucitone Denture Base Materials
K-Number: K182422 · 2018-12-18
ApplicantDentsply Sirona
Decision Date2018-12-18
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Lucitone Denture Base Materials is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2018-12-18 under approval number K182422. 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 Denture Base Materials?
Lucitone Denture Base Materials is a medical device that received FDA 510(k) clearance on 2018-12-18. It is manufactured by Dentsply Sirona. The 510(k) number is K182422.
When was Lucitone Denture Base Materials approved by the FDA?
Lucitone Denture Base Materials received FDA 510(k) clearance on 2018-12-18, under approval number K182422.
What company makes Lucitone Denture Base Materials?
Lucitone Denture Base Materials is manufactured by Dentsply Sirona.
What is the FDA product code for Lucitone Denture Base Materials?
The FDA product code for Lucitone Denture Base Materials 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.