510(k) clearance
Mouth Guard
- 510(k) number
- K262559
- Applicant
- ChangSha ChuangDuoLe E-Commerce Co., Ltd.
- Decision date
- Sep 16, 2026
- Date received
- Jul 24, 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
- Changsha, CN