meddevicedb.com FDA Device Reference

Mouth Guard

K262559 Traditional
Decision Date
2026-09-16
Sponsor / Applicant
ChangSha ChuangDuoLe E-Commerce Co., Ltd.

Technical Specification

510(k) Submission ID K262559
Product Code OBR
Medical Specialty / Panel Unknown
Decision Date 2026-09-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Mouth Guard received FDA 510(k) clearance under submission number K262559, sponsored by ChangSha ChuangDuoLe E-Commerce Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-09-16.

Classification & Regulation

This clearance is catalogued under FDA product code OBR , within the Unknown review panel as a device.