FDA 510(k)

Remi Custom Night Guard

K-Number: K243516 · 2025-02-10

Decision Date2025-02-10

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

Remi Custom Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Grindguard, Inc.. It received FDA 510(k) clearance on 2025-02-10 under 510(k) number K243516. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Remi Custom Night Guard?

Remi Custom Night Guard is a medical device that received FDA 510(k) clearance on 2025-02-10. The listed applicant is Grindguard, Inc.. The 510(k) number is K243516.

When did Remi Custom Night Guard receive FDA 510(k) clearance?

Remi Custom Night Guard received FDA 510(k) clearance on 2025-02-10, under 510(k) number K243516.

Who is the listed applicant for Remi Custom Night Guard?

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

What is the FDA product code for Remi Custom Night Guard?

The FDA product code for Remi Custom Night Guard is MQC.

Other records listing Grindguard, 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.

K251724Remi Impression Material

Related Devices (Code: MQC)

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K241369LIJIA Night GuardLijia, LLC K231775GR Resin System MSIPro3Dure Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.