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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 the device name listed in this FDA 510(k) record. The listed applicant is LuxCreo, Inc.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) 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. The listed applicant is LuxCreo, Inc.. The 510(k) number is K230592.

When did LuxCreo Dental Night Guard Resin receive FDA 510(k) clearance?

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

Who is the listed applicant for LuxCreo Dental Night Guard Resin?

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

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

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

Other records listing LuxCreo, Inc. as applicant

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.

K253365LuxCreo Flexible Partial Denture ResinK250343LuxCreo Clear Aligner SystemK212680LuxCreo Clear Aligner System

Related Devices (Code: MQC)

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.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

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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