Anesthesiology
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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- DYJRetainer, Screw Expansion, Orthodontic1Product Code
- DYOBand, Material, Orthodontic1Product Code
- DYTMaintainer, Space Preformed, Orthodontic1Product Code
- DYWBracket, Plastic, Orthodontic2Product Code
- DZBHeadgear, Extraoral, Orthodontic2Product Code
- DZCWire, Orthodontic1Product Code
- DZDTube, Orthodontic1Product Code
- ECIBand, Elastic, Orthodontic1Product Code
- ECMBand, Preformed, Orthodontic1Product Code
- ECNClamp, Wire, Orthodontic1Product Code
- ECOSpring, Orthodontic1Product Code
- EJFBracket, Metal, Orthodontic1Product Code
- KKORing, Teething, Fluid-Filled2Product Code
- K123855WATER-FILLED TEETHER2Cleared 510(K)
- K110615WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE2Cleared 510(K)
- K092025FLUID FILLED TEETHER - GEL2Cleared 510(K)
- K093266MAM COOLER2Cleared 510(K)
- K092781MAM TWISTER2Cleared 510(K)
- K092494GEL FILLED GUM SOOTHER2Cleared 510(K)
- K093370FU HONG INDUSTRIES LIMITED SOOTHER TEETHER2Cleared 510(K)
- K092910FLUID-FILLED TEETHER2Cleared 510(K)
- K091198LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING2Cleared 510(K)
- K090167PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,2Cleared 510(K)
- K082824FLUID FILLED TEETHER2Cleared 510(K)
- K083512FLUID-FILLED TEETHER2Cleared 510(K)
- K072082GUMEASE DENTAL MOUTHPIECE2Cleared 510(K)
- K052513BABY SNOOPY WATER FILLED TEETHER, MODEL 953672Cleared 510(K)
- K053493BERRY FRUITY TEETHER2Cleared 510(K)
- K052531FU HONG INDUSTRIES LIMITED SOOTHER TEETHER2Cleared 510(K)
- K052105WATER FILLED TEETHER2Cleared 510(K)
- K043033GLOBAL TREASURES FLUID FILLED TEETHER2Cleared 510(K)
- K031094FLUID FILLED TEETHERS2Cleared 510(K)
- K014023BABY TEETHER, MODEL 201042Cleared 510(K)
- K013587BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS2Cleared 510(K)
- K002066FREEZER TEETHER2Cleared 510(K)
- K981202WATER FILLED GUM SOOTHER2Cleared 510(K)
- K965082SOOTHING WATER-FILLED TEETHER2Cleared 510(K)
- K963912TYCO BABY SESAME STREET SOFT TEETHER2Cleared 510(K)
- K955069PLAYSKOOL2Cleared 510(K)
- K902974COOLING TEETHERS2Cleared 510(K)
- KMYPositioner, Tooth, Preformed1Product Code
- LQZDevice, Jaw Repositioning2Product Code
- LRKDevice, Anti-Snoring2Product Code
- LTFStimulator, Salivary System2Product Code
- MEFRing, Teething, Non-Fluid Filled1Product Code
- NJMBracket, Ceramic, Orthodontic2Product Code
- NLCBracket, Plastic, Orthodontic, Reprocessed2Product Code
- NQSBracket, Metal, Orthodontic, Reprocessed1Product Code
- NTORinse, Oral, Antibacterial (By Physical Means)2Product Code
- NXCAligner, Sequential2Product Code
- PLCSleep Appliances With Patient Monitoring2Product Code
- OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea2Product Code
- ORYPrelude Tongue Suspension System2Product Code
- OYHOrthodontic Vibratory Accessory2Product Code
- PLHOrthodontic Led Accessory2Product Code
- PNNOrthodontic Software2Product Code
- QCJClosed Loop Auto Titration Device For Oral Appliances2Product Code
- QJJIndirect Bonding Tray1Product Code
- QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea2Product Code
- QTTOver The Counter Electrical Salivary Stimulatory System2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
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- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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- PathologyReview Panel
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- UnknownReview Panel
FLUID-FILLED TEETHER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K083512
- 510(k) Type
- Traditional
- Applicant
- Wiltec Industries , Ltd.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/22/2009
- Days to Decision
- 147 days
- Submission Type
- Statement