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FDA 510(k)

Mouth Guard

K-Number: K262559 · 2026-09-16

ApplicantChangSha ChuangDuoLe E-Commerce Co., Ltd.
Decision Date2026-09-16
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

Mouth Guard is the device name listed in this FDA 510(k) record. The listed applicant is ChangSha ChuangDuoLe E-Commerce Co., Ltd.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K262559. 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 Mouth Guard?

Mouth Guard is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is ChangSha ChuangDuoLe E-Commerce Co., Ltd.. The 510(k) number is K262559.

When did Mouth Guard receive FDA 510(k) clearance?

Mouth Guard received FDA 510(k) clearance on 2026-09-16, under 510(k) number K262559.

Who is the listed applicant for Mouth Guard?

The FDA 510(k) record lists ChangSha ChuangDuoLe E-Commerce Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mouth Guard?

The FDA product code for Mouth Guard is OBR. This falls under the Orthopedic category.

Related Clinical Trials

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.

NCT04092660Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.RECRUITING

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.K252004enCore Night GuardEncore GuardsK251778Remi Custom Night GuardRemiK250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.

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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