Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5550](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5550) → KKO — Ring, Teething, Fluid-Filled # KKO · Ring, Teething, Fluid-Filled _Dental · 21 CFR 872.5550 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO ## Overview - **Product Code:** KKO - **Device Name:** Ring, Teething, Fluid-Filled - **Regulation:** [21 CFR 872.5550](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5550) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) ## Identification A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process. ## Classification Rationale Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. ## Special Controls *Classification.* Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. ## Recent Cleared Devices (20 of 27) Showing 20 most recent of 27 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K123855](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K123855.md) | WATER-FILLED TEETHER | Solid Toys Ind. , Ltd. | May 24, 2013 | SESE | | [K110615](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K110615.md) | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | Bebe Toys Manufactory , Ltd. | Dec 2, 2011 | SESE | | [K092025](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K092025.md) | FLUID FILLED TEETHER - GEL | Kids II | Jan 27, 2011 | SESE | | [K093266](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K093266.md) | MAM COOLER | Mam International AG | Jul 27, 2010 | SESE | | [K092781](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K092781.md) | MAM TWISTER | Mam International AG | Jun 23, 2010 | SESE | | [K092494](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K092494.md) | GEL FILLED GUM SOOTHER | Luv N' Care, Ltd. | Mar 1, 2010 | SESE | | [K093370](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K093370.md) | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | Jan 21, 2010 | SESE | | [K092910](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K092910.md) | FLUID-FILLED TEETHER | Qualiman Industrial Co., Ltd. | Dec 18, 2009 | SESE | | [K091198](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K091198.md) | LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING | Allied Hill Enterprises, Ltd. | Dec 7, 2009 | SESE | | [K090167](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K090167.md) | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, | Philips Electronics UK Limited | Jun 18, 2009 | SESE | | [K082824](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K082824.md) | FLUID FILLED TEETHER | Kids II | May 27, 2009 | SESE | | [K083512](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K083512.md) | FLUID-FILLED TEETHER | Wiltec Industries , Ltd. | Apr 22, 2009 | SESE | | [K072082](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K072082.md) | GUMEASE DENTAL MOUTHPIECE | Biomedevice , Ltd. | Nov 5, 2007 | SESE | | [K052513](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K052513.md) | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 | Delta Enterprise Corporation | Jun 28, 2006 | SESE | | [K053493](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K053493.md) | BERRY FRUITY TEETHER | Evenflo Company, Inc. | Feb 22, 2006 | SESE | | [K052531](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K052531.md) | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | Dec 14, 2005 | SESE | | [K052105](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K052105.md) | WATER FILLED TEETHER | Royal Industries (Thailand) Public Co. , Ltd. | Oct 31, 2005 | SESE | | [K043033](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K043033.md) | GLOBAL TREASURES FLUID FILLED TEETHER | Global Treasure Industries , Ltd. | Mar 22, 2005 | SESE | | [K031094](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K031094.md) | FLUID FILLED TEETHERS | Royal King Infant Products Co. , Ltd. | Dec 8, 2003 | SESE | | [K014023](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO/K014023.md) | BABY TEETHER, MODEL 20104 | Angelina Trading, Inc. | Aug 2, 2002 | SESE | ## Top Applicants - Fu Hong Industries , Ltd. — 2 clearances - Kids II — 2 clearances - Mam International AG — 2 clearances - Allied Hill Enterprises, Ltd. — 1 clearance - Angelina Trading, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KKO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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