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FDA 510(k)

enCore Night Guard

K-Number: K252004 · 2025-11-25

ApplicantEncore Guards
Decision Date2025-11-25
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

enCore Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Encore Guards. It received FDA 510(k) clearance on 2025-11-25 under 510(k) 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. The listed applicant is Encore Guards. The 510(k) number is K252004.

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

enCore Night Guard received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252004.

Who is the listed applicant for enCore Night Guard?

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

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.

Other records listing Encore Guards 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.

K251926enCore Impression Material

Related Devices (Code: OBR)

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.

K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media LimitedK253641Owl Night GuardOwl Dental Lab, Inc.K251778Remi Custom Night GuardRemiK250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.K240810Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd.

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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