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KKO — Ring, Teething, Fluid-Filled Class II

FDA Device Classification

FDA product code KKO covers "Ring, Teething, Fluid-Filled", a Class II medical device regulated under 21 CFR 872.5550. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification details

Product Code
KKO
Device Class
Class II
Regulation Number
872.5550
Submission Type
510(k) Exempt
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) clearances

K-NumberApplicantDevice NameDate
K123855Solid Toys Ind.WATER-FILLED TEETHERMay 24, 2013
K110615Bebe Toys ManufactoryWATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLEDec 2, 2011
K092025Kids IiFLUID FILLED TEETHER - GELJan 27, 2011
K093266Mam InternationalMAM COOLERJul 27, 2010
K092781Mam InternationalMAM TWISTERJun 23, 2010
K092494Luv N' CareGEL FILLED GUM SOOTHERMar 1, 2010
K093370Fu Hong IndustriesFU HONG INDUSTRIES LIMITED SOOTHER TEETHERJan 21, 2010
K092910Qualiman Industrial CoFLUID-FILLED TEETHERDec 18, 2009
K091198Allied Hill EnterprisesLIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS…Dec 7, 2009
K090167Philips Electronics Uk LimitedPHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS…Jun 18, 2009
K082824Kids IiFLUID FILLED TEETHERMay 27, 2009
K083512Wiltec IndustriesFLUID-FILLED TEETHERApr 22, 2009
K072082BiomedeviceGUMEASE DENTAL MOUTHPIECENov 5, 2007
K052513Delta Enterprise CorporationBABY SNOOPY WATER FILLED TEETHER, MODEL 95367Jun 28, 2006
K053493Evenflo CompanyBERRY FRUITY TEETHERFeb 22, 2006
K052531Fu Hong IndustriesFU HONG INDUSTRIES LIMITED SOOTHER TEETHERDec 14, 2005
K052105Royal Industries (Thailand) Public Co.WATER FILLED TEETHEROct 31, 2005
K043033Global Treasure IndustriesGLOBAL TREASURES FLUID FILLED TEETHERMar 22, 2005
K031094Royal King Infant Products Co.FLUID FILLED TEETHERSDec 8, 2003
K014023Angelina TradingBABY TEETHER, MODEL 20104Aug 2, 2002

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.