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FDA 510(k)

Remi Custom Night Guard

K-Number: K251778 · 2025-10-17

ApplicantRemi
Decision Date2025-10-17
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

Remi Custom Night Guard is a medical device manufactured by Remi. It received FDA 510(k) clearance on 2025-10-17 under approval number K251778. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. 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 2025-10-17. It is manufactured by Remi. The 510(k) number is K251778.

When was Remi Custom Night Guard approved by the FDA?

Remi Custom Night Guard received FDA 510(k) clearance on 2025-10-17, under approval number K251778.

What company makes Remi Custom Night Guard?

Remi Custom Night Guard is manufactured by Remi.

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

The FDA product code for Remi Custom Night Guard is OBR. This falls under the Orthopedic category.

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Related PubMed Literature

PMID: 41638310 Lower Extremity Complications in Adults With Type 2 Diabetes Treated With Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas: An Emulated Target Trial. Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (2026)

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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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