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FDA 510(k)

LuxCreo Dental Night Guard Resin

K-Number: K230592 · 2024-01-18

ApplicantLuxCreo, Inc.
Decision Date2024-01-18
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

LuxCreo Dental Night Guard Resin is a medical device manufactured by LuxCreo, Inc.. It received FDA 510(k) clearance on 2024-01-18 under approval number K230592. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LuxCreo Dental Night Guard Resin?

LuxCreo Dental Night Guard Resin is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by LuxCreo, Inc.. The 510(k) number is K230592.

When was LuxCreo Dental Night Guard Resin approved by the FDA?

LuxCreo Dental Night Guard Resin received FDA 510(k) clearance on 2024-01-18, under approval number K230592.

What company makes LuxCreo Dental Night Guard Resin?

LuxCreo Dental Night Guard Resin is manufactured by LuxCreo, Inc..

What is the FDA product code for LuxCreo Dental Night Guard Resin?

The FDA product code for LuxCreo Dental Night Guard Resin is MQC.

Related Clinical Trials

NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT04945993 Tooth Retention After Root Canal Treatment With Endomethasone N ACTIVE_NOT_RECRUITING NCT07548502 Effect of Night Guard Use on Masseter Muscle Thickness in Children With Bruxism RECRUITING NCT07350343 The Predictability of Directly Printed Versus Thermoformed Clear Aligners ENROLLING_BY_INVITATION NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

Other Devices by LuxCreo, Inc.

K212680LuxCreo Clear Aligner System K253365LuxCreo Flexible Partial Denture Resin K250343LuxCreo Clear Aligner System

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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.

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