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FDA 510(k)

Remi Custom Night Guard

K-Number: K243516 · 2025-02-10

ApplicantGrindguard, Inc.
Decision Date2025-02-10
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Remi Custom Night Guard is a medical device manufactured by Grindguard, Inc.. It received FDA 510(k) clearance on 2025-02-10 under approval 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. It is manufactured by Grindguard, Inc.. The 510(k) number is K243516.

When was Remi Custom Night Guard approved by the FDA?

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

What company makes Remi Custom Night Guard?

Remi Custom Night Guard is manufactured by Grindguard, Inc..

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

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

Related Clinical Trials

NCT06899711 External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients RECRUITING NCT07548502 Effect of Night Guard Use on Masseter Muscle Thickness in Children With Bruxism RECRUITING

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K251724Remi Impression Material

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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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