510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K262559Substantially Equivalent

Mouth Guard

ChangSha ChuangDuoLe E-Commerce Co., Ltd., Changsha, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

Clearance record

Decision date
Received
(54 days to decision)
Product code
OBR Mouthguard, Over-The-Counter
Device class
Unclassified
Review panel
Unknown
Applicant
ChangSha ChuangDuoLe E-Commerce Co., Ltd. Rm.703, 7/F, Bldg. E7, Phase Ii, Cec Software Park, # 18 Jia, Changsha, CN
510(k) summary
Statement
Third party review
No

Clearances, product code OBR

Trailing 12 months
5 clearances under product code OBR in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OBR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260