Product code KKO
- Device name
- Ring, Teething, Fluid-Filled
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.5550
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123855 | WATER-FILLED TEETHER | Solid Toys Ind. , Ltd. | 2013-05-24 |
| K110615 | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | Bebe Toys Manufactory , Ltd. | 2011-12-02 |
| K092025 | FLUID FILLED TEETHER - GEL | Kids II | 2011-01-27 |
| K093266 | MAM COOLER | Mam International AG | 2010-07-27 |
| K092781 | MAM TWISTER | Mam International AG | 2010-06-23 |
| K092494 | GEL FILLED GUM SOOTHER | Luv N' Care, Ltd. | 2010-03-01 |
| K093370 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | 2010-01-21 |
| K092910 | FLUID-FILLED TEETHER | Qualiman Industrial Co., Ltd. | 2009-12-18 |
| K091198 | LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING | Allied Hill Enterprises, Ltd. | 2009-12-07 |
| 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 | 2009-06-18 |
| K082824 | FLUID FILLED TEETHER | Kids II | 2009-05-27 |
| K083512 | FLUID-FILLED TEETHER | Wiltec Industries , Ltd. | 2009-04-22 |
| K072082 | GUMEASE DENTAL MOUTHPIECE | Biomedevice , Ltd. | 2007-11-05 |
| K052513 | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 | Delta Enterprise Corporation | 2006-06-28 |
| K053493 | BERRY FRUITY TEETHER | Evenflo Company, Inc. | 2006-02-22 |
| K052531 | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | Fu Hong Industries , Ltd. | 2005-12-14 |
| K052105 | WATER FILLED TEETHER | Royal Industries (Thailand) Public Co. , Ltd. | 2005-10-31 |
| K043033 | GLOBAL TREASURES FLUID FILLED TEETHER | Global Treasure Industries , Ltd. | 2005-03-22 |
| K031094 | FLUID FILLED TEETHERS | Royal King Infant Products Co. , Ltd. | 2003-12-08 |
| K014023 | BABY TEETHER, MODEL 20104 | Angelina Trading, Inc. | 2002-08-02 |
| K013587 | BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS | Babies Best, Inc. | 2002-05-14 |
| K002066 | FREEZER TEETHER | Cool Baby, Inc. | 2000-09-26 |
| K981202 | WATER FILLED GUM SOOTHER | Corium Corp. | 1998-06-16 |
| K965082 | SOOTHING WATER-FILLED TEETHER | Consolidated Stores Corp. | 1997-03-11 |
| K963912 | TYCO BABY SESAME STREET SOFT TEETHER | Regu-Tech Assoc., Inc. | 1996-11-06 |
| K955069 | PLAYSKOOL | Hasbro, Inc. | 1995-12-22 |
| K902974 | COOLING TEETHERS | Realgrow Intl. Corp. | 1991-04-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00037977810318 | Sassy | SASSY BABY, INC. | 2026-05-21 |
| B740TE0310 | Dr. Brown's | Dr. Brown's Company | 2025-05-23 |
| 00039175811777 | Nuby | LUV N' CARE, LTD. | 2025-01-07 |
| B740TE0280 | Dr. Brown's | Dr. Brown's Company | 2023-09-20 |
| B740TE0290 | Dr. Brown's | Dr. Brown's Company | 2023-09-20 |
| 00048526069385 | Nuby | LUV N' CARE, LTD. | 2022-05-26 |
| B740TE0240 | Dr. Brown's | Dr. Brown's Company | 2022-01-31 |
| 00048526066483 | Nuby | LUV N' CARE, LTD. | 2021-08-27 |
| 00048526069378 | Nuby | LUV N' CARE, LTD. | 2021-08-13 |
| 00048526068845 | Nuby | LUV N' CARE, LTD. | 2020-10-23 |
| 00048526069095 | Nuby | LUV N' CARE, LTD. | 2020-10-23 |
| 00048526069217 | Nuby | LUV N' CARE, LTD. | 2020-10-23 |
| 00048526006212 | Nuby | LUV N' CARE, LTD. | 2020-10-23 |
| B268Y5288L0 | Lamaze | TOMY INTERNATIONAL, INC. | 2019-10-11 |
| B268L276190 | Lamaze | TOMY INTERNATIONAL, INC. | 2018-07-01 |
| 00048526009985 | Nuby | LUV N' CARE, LTD. | 2017-07-19 |
| 00048526924196 | Nuby | LUV N' CARE, LTD. | 2017-05-24 |
| 00688267164491 | Always My Baby | LUV N' CARE, LTD. | 2017-05-24 |
| 00032251197840 | Kidgets | Regent Baby Products Corp. | 2017-05-02 |
| 00715418028590 | Green Sprouts | O2cool, LLC | 2017-04-12 |
| 00048526006243 | Nuby | LUV N' CARE, LTD. | 2016-12-06 |
| 00048526006717 | Nuby | LUV N' CARE, LTD. | 2016-11-09 |
| 00048526006250 | Nuby | LUV N' CARE, LTD. | 2016-11-09 |
| 00048526006021 | Nuby | LUV N' CARE, LTD. | 2016-11-09 |
| 00048526006014 | Nuby | LUV N' CARE, LTD. | 2016-11-02 |
| 00048526006007 | Nuby | LUV N' CARE, LTD. | 2016-11-02 |
| 00048526005673 | Nuby | LUV N' CARE, LTD. | 2016-11-02 |
| 00048526005093 | Nuby | LUV N' CARE, LTD. | 2016-11-01 |
| 00715418091136 | Green Sprouts | O2cool, LLC | 2016-09-15 |
| 00715418020358 | Green Sprouts | O2cool, LLC | 2016-08-23 |