Mouth Guard— 510(k) K262559
Substantially EquivalentChangSha ChuangDuoLe E-Commerce Co., Ltd.
FDA 510(k) clearance K262559 for Mouth Guard, Substantially Equivalent on 2026-09-16. Applicant: ChangSha ChuangDuoLe E-Commerce Co., Ltd.. Device class: Unclassified.
Summary
ChangSha ChuangDuoLe E-Commerce Co., Ltd. filed a device named only "Mouth Guard" under product code OBR (Mouthguard, Over-The-Counter). The name is generic, and the record gives no model number.
Class U, with no regulation number. The classification panel is listed as Unknown, and the Dental review panel handled it as a Traditional 510(k). The decision was Substantially Equivalent.
The company filed from Changsha, China. The decision came 54 calendar days after receipt (July 24 to September 16, 2026).
Clearance details
- Applicant
- ChangSha ChuangDuoLe E-Commerce Co., Ltd.
- Product code
- Product code OBR
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changsha, CN
Recent devices under product code OBR
view allData sourced from openFDA. This site is unofficial and independent of the FDA.