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Found 18 results
510(k) Data Aggregation
K Number
K123855Device Name
WATER-FILLED TEETHER
Manufacturer
SOLID TOYS IND. LTD.
Date Cleared
2013-05-24
(161 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated to soothe and cool teething babies and help reduce teething pain.
Device Description
The proposed Water-filled teether is a simple plastic shaped device which is filled with water. It may be placed in a refrigerator to be cooled and then provided to the teething baby to help sooth any pain from teething. This is an OTC device.
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K Number
K110615Device Name
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
Manufacturer
BEBE TOYS MANUFACTORY LTD.
Date Cleared
2011-12-02
(274 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.
Device Description
Not Found
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K Number
K092025Device Name
FLUID FILLED TEETHER - GEL
Manufacturer
KIDS II
Date Cleared
2011-01-27
(570 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All teethers instruct consumer to: .
- Clean before use with a damp cloth and mild soap. Air dry. o
- o Not dishwasher safe
- Freezer safe ◆
Teether acts as an aid in relieving an infant's gums due to teething. .
Device Description
Fluid Filled Teether - Gel
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K Number
K092781Device Name
MAM TWISTER
Manufacturer
MAM INTERNATIONAL AG
Date Cleared
2010-06-23
(286 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAM Twister Teether was developed for the needs of babies who are having their first teeths. It is designed to offer optimum comfort and safety for the baby and offers all the soothing textures and cooling comfort in order to ease babies teething pain.
Device Description
Class II Fluid-Filled Teething Ring (Teether with waterfilled part) that that meets requirements of USP <61>, ASTM F963 section 4.3.6.1 & 4.3.6.3, 16 CFR 1303 - Ban of lead-containing paint (< 90 ppm), CPSIA Sec.101: general lead ban - lead in substrate (< 100 ppm), 16 CFR 1500 - Mechanical Hazards, ASTM F963 - toy standard, 16 CFR 1500.44 - Flammability of solids, 16CFR1501 - Small part requirement, CPS1A Sec.108 & CA Bill 1108 - Ban on phthalates (DEHP, DBP, DINP, DIDP, DIDP, DIOP < 0,1%), 16 CFR 1500.52(c) - Bite test, EN 71-1, EN 71-3 & EN 71-9
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K Number
K092494Device Name
GEL FILLED GUM SOOTHER
Manufacturer
LUV N' CARE, LTD.
Date Cleared
2010-03-01
(199 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.
Device Description
Teething Ring – Water or Gel Filled
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K Number
K093370Device Name
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
Manufacturer
FU HONG INDUSTRIES LTD.
Date Cleared
2010-01-21
(84 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fu Hong Industries Limited Soother Teether is a fluid filled teether indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
Device Description
Not Found
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K Number
K092910Device Name
FLUID-FILLED TEETHER
Manufacturer
QUALIMAN INDUSTRIAL CO., LTD
Date Cleared
2009-12-18
(87 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
Device Description
Not Found
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K Number
K091198Device Name
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
Manufacturer
ALLIED HILL ENTERPRISES, LTD.
Date Cleared
2009-12-07
(227 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Water Filled Teether is used for the temporary relief of pain and discomfort in infants and toddlers caused by teething.
Device Description
Water Filled Teether
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K Number
K083512Device Name
FLUID-FILLED TEETHER
Manufacturer
WILTEC INDUSTRIES LTD.
Date Cleared
2009-04-22
(147 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.
Device Description
Not Found
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K Number
K072082Device Name
GUMEASE DENTAL MOUTHPIECE
Manufacturer
BIOMEDEVICE LTD.
Date Cleared
2007-11-05
(98 days)
Product Code
KKO
Regulation Number
872.5550Why did this record match?
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Matched: '872.5550'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The gumEase® dental mouthpiece provides temporary relief from oral discomfort resulting from dental work, brace pain, denture irritation, post surgical pain or minor oral trauma.
Device Description
The gumEase® dental mouth piece is manufactured from biocompatible plastic tubing that is filled with a NaCl solution.
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