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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2018-12-18 under 510(k) 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. The listed applicant is Dentsply Sirona. The 510(k) number is K182422.

When did Lucitone Denture Base Materials receive FDA 510(k) clearance?

Lucitone Denture Base Materials received FDA 510(k) clearance on 2018-12-18, under 510(k) number K182422.

Who is the listed applicant for Lucitone Denture Base Materials?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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.

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