510(k) clearances

Mouth Guard

ChangSha ChuangDuoLe E-Commerce Co., Ltd. · Unknown

K262559Substantially EquivalentTraditionalOBR
Open FDA's page for this record
Third party flag
N
City
Changsha
Advisory committee description
Unknown
Address 1
Rm.703, 7/F, Bldg. E7, Phase Ii, Cec Software Park, # 18 Jia
Address 2
Dongfanghong St., Hi-Tech Development Zone
Statement or summary
Statement
Product code
OBR
Zip code
410000
Applicant
ChangSha ChuangDuoLe E-Commerce Co., Ltd.
Decision date
2026-09-16
Decision code
SESE
Country code
CN
Device name
Mouth Guard
Contact
Wei Luo
K number
K262559
Date received
2026-07-24
Review advisory committee
DE
Postal code
410000
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Mouthguard, Over-The-Counter
Medical specialty description
Unknown
Device class
U
Registration number
3008808560, 3030268763, 3020749939, 3019729646, 3010358861, 3007336881, 2529596, 3017968320, 3013652641, 3017575849, 3008808087, 3039524192, 3003283852, 3006789197, 3011547262, 3027283275, 3028271666, 3029913483, 1818945, 3004727093, 2938386, 3029507159, 1825660, 3010767848, 3015128224, 1833025, 3008763803, 3011545197, 3015525101, 3009133124, 1719513, 1723435, 3001237145, 3011545201, 3047906342, 3002911411
FEI number
3030268763, 3020749939, 3019729646, 3010358861, 3007336881, 3017968320, 3013652641, 3017575849, 3008808087, 3039524192, 3003283852, 3006789197, 3011547262, 3027283275, 3028271666, 3029913483, 1818945, 3000203342, 3004727093, 2938386, 3029507159, 1000121324, 1825660, 3010767848, 3015128224, 1833025, 3008763803, 3011545197, 3015525101, 3009133124, 1719513, 3001237145, 3011545201, 3047906342, 3004601847, 3002911411
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.