KKO — Ring, Teething, Fluid-Filled Class II
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
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123855 | solid toys ind. | WATER-FILLED TEETHER | May 24, 2013 |
| K110615 | bebe toys manufactory | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | December 2, 2011 |
| K092025 | kids ii | FLUID FILLED TEETHER - GEL | January 27, 2011 |
| K093266 | mam international | MAM COOLER | July 27, 2010 |
| K092781 | mam international | MAM TWISTER | June 23, 2010 |
| K092494 | luv n' care | GEL FILLED GUM SOOTHER | March 1, 2010 |
| K093370 | fu hong industries | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | January 21, 2010 |
| K092910 | qualiman industrial co | FLUID-FILLED TEETHER | December 18, 2009 |
| K091198 | allied hill enterprises | LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962 | December 7, 2009 |
| K090167 | philips electronics uk limited | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS | June 18, 2009 |
| K082824 | kids ii | FLUID FILLED TEETHER | May 27, 2009 |
| K083512 | wiltec industries | FLUID-FILLED TEETHER | April 22, 2009 |
| K072082 | biomedevice | GUMEASE DENTAL MOUTHPIECE | November 5, 2007 |
| K052513 | delta enterprise corporation | BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 | June 28, 2006 |
| K053493 | evenflo company | BERRY FRUITY TEETHER | February 22, 2006 |
| K052531 | fu hong industries | FU HONG INDUSTRIES LIMITED SOOTHER TEETHER | December 14, 2005 |
| K052105 | royal industries (thailand) public co. | WATER FILLED TEETHER | October 31, 2005 |
| K043033 | global treasure industries | GLOBAL TREASURES FLUID FILLED TEETHER | March 22, 2005 |
| K031094 | royal king infant products co. | FLUID FILLED TEETHERS | December 8, 2003 |
| K014023 | angelina trading | BABY TEETHER, MODEL 20104 | August 2, 2002 |