Mouth guard— 510(k) K262280

Name: FDA 510(k) clearance K262280
Creator: U.S. Food and Drug Administration
Published: 2026-10-26

Substantially Equivalent

Dongguan Yiyao Science & Technology Development Co., Ltd.

FDA 510(k) clearance K262280 for Mouth guard, Substantially Equivalent on 2026-10-26. Applicant: Dongguan Yiyao Science & Technology Development Co., Ltd.. Device class: Unclassified.

Clearance details

Applicant: Dongguan Yiyao Science & Technology Development Co., Ltd.
Product code: Product code OBR
Device class: Unclassified
Advisory panel: Unknown
Date received: 2026-07-06
Decision date: 2026-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBR

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K262559 — Mouth Guard2026-09-16
K260790 — G-Series Grind Guard2026-06-25
K252485 — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))2026-04-10
K253641 — Owl Night Guard2026-02-26
K252004 — enCore Night Guard2025-11-25

More clearances from Dongguan Yiyao Science & Technology Development Co., Ltd.

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K250028 — Anti Snore Mouthpiece2025-10-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.