enCore Night Guard
K-Number: K252004 · 2025-11-25
Device Summary
enCore Night Guard is a medical device manufactured by Encore Guards. It received FDA 510(k) clearance on 2025-11-25 under approval number K252004. 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 enCore Night Guard?
enCore Night Guard is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Encore Guards. The 510(k) number is K252004.
When was enCore Night Guard approved by the FDA?
enCore Night Guard received FDA 510(k) clearance on 2025-11-25, under approval number K252004.
What company makes enCore Night Guard?
enCore Night Guard is manufactured by Encore Guards.
What is the FDA product code for enCore Night Guard?
The FDA product code for enCore Night Guard is OBR. This falls under the Orthopedic category.
Related Clinical Trials
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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.