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FDA 510(k)

LuxCreo Flexible Partial Denture Resin

K-Number: K253365 · 2025-11-25

ApplicantLuxCreo, Inc.
Decision Date2025-11-25
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LuxCreo Flexible Partial Denture Resin is a medical device manufactured by LuxCreo, Inc.. It received FDA 510(k) clearance on 2025-11-25 under approval number K253365. 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 LuxCreo Flexible Partial Denture Resin?

LuxCreo Flexible Partial Denture Resin is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by LuxCreo, Inc.. The 510(k) number is K253365.

When was LuxCreo Flexible Partial Denture Resin approved by the FDA?

LuxCreo Flexible Partial Denture Resin received FDA 510(k) clearance on 2025-11-25, under approval number K253365.

What company makes LuxCreo Flexible Partial Denture Resin?

LuxCreo Flexible Partial Denture Resin is manufactured by LuxCreo, Inc..

What is the FDA product code for LuxCreo Flexible Partial Denture Resin?

The FDA product code for LuxCreo Flexible Partial Denture Resin is EBI.

Related Clinical Trials

NCT07608211 Development of a Sanitizing Tablet for Removable Partial Dentures NOT_YET_RECRUITING NCT07592325 Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis RECRUITING NCT07522671 Clinical Performance of 3D-Printed Resin and Zirconia Implant Restorations RECRUITING

Other Devices by LuxCreo, Inc.

K212680LuxCreo Clear Aligner System K230592LuxCreo Dental Night Guard Resin K250343LuxCreo Clear Aligner System

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.

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