KKO · Ring, Teething, Fluid-Filled
Dental · 21 CFR 872.5550 · Class 2
Overview
| Product Code | KKO |
|---|---|
| Device Name | Ring, Teething, Fluid-Filled |
| Regulation | 21 CFR 872.5550 |
| Device Class | Class 2 |
| Review Panel | Dental |
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 | WATER-FILLED TEETHER | Solid Toys Ind. , Ltd. | May 24, 2013 | SESE |
| K110615 | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | Bebe Toys Manufactory , Ltd. | Dec 2, 2011 | SESE |
| K092025 | FLUID FILLED TEETHER - GEL | Kids II | Jan 27, 2011 | SESE |
| K093266 | MAM COOLER | Mam International AG | Jul 27, 2010 | SESE |
| K092781 | MAM TWISTER | Mam International AG | Jun 23, 2010 | SESE |
| K092494 | GEL FILLED GUM SOOTHER | Luv N' Care, Ltd. | Mar 1, 2010 | SESE |
| K093370 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | Jan 21, 2010 | SESE |
| K092910 | FLUID-FILLED TEETHER | Qualiman Industrial Co., Ltd. | Dec 18, 2009 | SESE |
| K091198 | 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 | 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 | FLUID FILLED TEETHER | Kids II | May 27, 2009 | SESE |
| K083512 | FLUID-FILLED TEETHER | Wiltec Industries , Ltd. | Apr 22, 2009 | SESE |
| K072082 | GUMEASE DENTAL MOUTHPIECE | Biomedevice , Ltd. | Nov 5, 2007 | SESE |
| K052513 | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 | Delta Enterprise Corporation | Jun 28, 2006 | SESE |
| K053493 | BERRY FRUITY TEETHER | Evenflo Company, Inc. | Feb 22, 2006 | SESE |
| K052531 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | Dec 14, 2005 | SESE |
| K052105 | WATER FILLED TEETHER | Royal Industries (Thailand) Public Co. , Ltd. | Oct 31, 2005 | SESE |
| K043033 | GLOBAL TREASURES FLUID FILLED TEETHER | Global Treasure Industries , Ltd. | Mar 22, 2005 | SESE |
| K031094 | FLUID FILLED TEETHERS | Royal King Infant Products Co. , Ltd. | Dec 8, 2003 | SESE |
| K014023 | 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
