Product Code: KKO FDA class 2 21 CFR 872.5550

Ring, Teething, Fluid-Filled

Dental

The Fluid-Filled Teething Ring is a dental device used to provide relief for infants during teething by applying gentle pressure and cooling to sore gums. It is classified as FDA Class 2, representing moderate risk, meaning manufacturers must submit a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KKO and it is regulated under 21 CFR 872.5550 in the Dental specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KKO
Device Class: FDA class 2
Regulation Number: 872.5550
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K123855	WATER-FILLED TEETHER	May 24, 2013	Substantially Equivalent	Solid Toys Ind. , Ltd.
K110615	WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE	Dec 02, 2011	Substantially Equivalent	Bebe Toys Manufactory , Ltd.
K092025	FLUID FILLED TEETHER - GEL	Jan 27, 2011	Substantially Equivalent	Kids II
K093266	MAM COOLER	Jul 27, 2010	Substantially Equivalent	Mam International AG
K092781	MAM TWISTER	Jun 23, 2010	Substantially Equivalent	Mam International AG
K092494	GEL FILLED GUM SOOTHER	Mar 01, 2010	Substantially Equivalent	Luv N' Care, Ltd.
K093370	FU HONG INDUSTRIES LIMITED SOOTHER TEETHER	Jan 21, 2010	Substantially Equivalent	Fu Hong Industries , Ltd.
K092910	FLUID-FILLED TEETHER	Dec 18, 2009	Substantially Equivalent	Qualiman Industrial Co., Ltd.
K091198	LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING	Dec 07, 2009	Substantially Equivalent	Allied Hill Enterprises, Ltd.
K090167	PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,	Jun 18, 2009	Substantially Equivalent	Philips Electronics UK Limited
K082824	FLUID FILLED TEETHER	May 27, 2009	Substantially Equivalent	Kids II
K083512	FLUID-FILLED TEETHER	Apr 22, 2009	Substantially Equivalent	Wiltec Industries , Ltd.
K072082	GUMEASE DENTAL MOUTHPIECE	Nov 05, 2007	Substantially Equivalent	Biomedevice , Ltd.
K052513	BABY SNOOPY WATER FILLED TEETHER, MODEL 95367	Jun 28, 2006	Substantially Equivalent	Delta Enterprise Corporation
K053493	BERRY FRUITY TEETHER	Feb 22, 2006	Substantially Equivalent	Evenflo Company, Inc.
K052531	FU HONG INDUSTRIES LIMITED SOOTHER TEETHER	Dec 14, 2005	Substantially Equivalent	Fu Hong Industries , Ltd.
K052105	WATER FILLED TEETHER	Oct 31, 2005	Substantially Equivalent	Royal Industries (Thailand) Public Co. , Ltd.
K043033	GLOBAL TREASURES FLUID FILLED TEETHER	Mar 22, 2005	Substantially Equivalent	Global Treasure Industries , Ltd.
K031094	FLUID FILLED TEETHERS	Dec 08, 2003	Substantially Equivalent	Royal King Infant Products Co. , Ltd.
K014023	BABY TEETHER, MODEL 20104	Aug 02, 2002	Substantially Equivalent	Angelina Trading, Inc.
K013587	BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS	May 14, 2002	Substantially Equivalent	Babies Best, Inc.
K002066	FREEZER TEETHER	Sep 26, 2000	Substantially Equivalent	Cool Baby, Inc.
K981202	WATER FILLED GUM SOOTHER	Jun 16, 1998	Substantially Equivalent	Corium Corp.
K965082	SOOTHING WATER-FILLED TEETHER	Mar 11, 1997	Substantially Equivalent	Consolidated Stores Corp.
K963912	TYCO BABY SESAME STREET SOFT TEETHER	Nov 06, 1996	Substantially Equivalent	Regu-Tech Assoc., Inc.
K955069	PLAYSKOOL	Dec 22, 1995	Substantially Equivalent	Hasbro, Inc.
K902974	COOLING TEETHERS	Apr 03, 1991	Substantially Equivalent	Realgrow Intl. Corp.