510(k) clearance

Mouth guard

FDA 510(k) source

510(k) number

K262280

Applicant

Dongguan Yiyao Science & Technology Development Co., Ltd.

Decision date

Oct 26, 2026

Date received

Jul 6, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

OBR

Device type

Mouthguard, Over-The-Counter

Device class

Unclassified

Advisory committee

Unknown

Statement or summary

Statement

Third party

N

Location

Dongguan, CN