Anesthesiology
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- MiscellaneousMiscellaneous
- 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
- DZSCapsule, Dental, Amalgam1Product Code
- DYHAdhesive, Bracket And Tooth Conditioner, Resin2Product Code
- DZEImplant, Endosseous, Root-Form2Product Code
- EBCSealant, Pit And Fissure, And Conditioner2Product Code
- EBDCoating, Filling Material, Resin2Product Code
- EBECoating, Denture Hydrophilic, Resin2Product Code
- EBFMaterial, Tooth Shade, Resin2Product Code
- EBGCrown And Bridge, Temporary, Resin2Product Code
- EBHMaterial, Impression Tray, Resin1Product Code
- EBIResin, Denture, Relining, Repairing, Rebasing2Product Code
- EBLPin, Retentive And Splinting, And Accessory Instruments1Product Code
- EBODenture Repair Kit2Product Code
- EBPReliner, Denture, Over The Counter2Product Code
- EFDAmalgamator, Dental, Ac-Powered1Product Code
- EFTCleanser, Denture, Over The Counter1Product Code
- EGGAttachment, Precision, All1Product Code
- EHEDispenser, Mercury And/Or Alloy1Product Code
- EHOBar, Preformed1Product Code
- EHPClasp, Preformed1Product Code
- EHQCusp, Preformed1Product Code
- EHRPad, Denture, Over The Counter2Product Code
- EHSCushion, Denture, Over The Counter2Product Code
- EITApplicator, Rapid Wax, Dental2Product Code
- EJHAlloy, Metal, Base2Product Code
- EJJAlloy, Amalgam2Product Code
- EJKLiner, Cavity, Calcium Hydroxide2Product Code
- EJLBur, Dental1Product Code
- EJPArticulators1Product Code
- EJSAlloy, Other Noble Metal2Product Code
- EJTAlloy, Gold-Based Noble Metal2Product Code
- EJWClasp, Wire1Product Code
- EJXAnchor, Preformed1Product Code
- EKLPoint, Silver, Endodontic1Product Code
- EKMGutta-Percha1Product Code
- EKNPoint, Paper, Endodontic1Product Code
- EKODenture Preformed (Partially Prefabricated Denture)2Product Code
- ELEImplant, Subperiosteal2Product Code
- ELJTeeth, Artificial, Posterior With Metal Insert1Product Code
- ELKTeeth, Artificial, Backing And Facing1Product Code
- ELLTeeth, Porcelain2Product Code
- ELMDenture, Plastic, Teeth2Product Code
- ELNTeeth, Preformed Gold Denture1Product Code
- ELOCusp, Gold And Stainless Steel1Product Code
- ELRPost, Root Canal1Product Code
- ELSSplint, Endodontic Stabilizing2Product Code
- ELWMaterial, Impression2Product Code
- ELYMercury2Product Code
- ELZCrown, Preformed1Product Code
- EMACement, Dental2Product Code
- EMBZinc Oxide Eugenol1Product Code
- JERCleaner, Denture, Mechanical1Product Code
- KCRFacebow1Product Code
- KCSPantograph1Product Code
- KIFResin, Root Canal Filling2Product Code
- KLEAgent, Tooth Bonding, Resin2Product Code
- KOLAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer1Product Code
- KOMAdhesive, Denture, Acacia And Karaya With Sodium Borate1Product Code
- KONAdhesive, Denture, Polyacrylamide Polymer (Modified Cationic)3Product Code
- KOOAdhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt1Product Code
- KOPAdhesive, Denture, Karaya1Product Code
- KOQAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)1Product Code
- KORAdhesive, Denture, Karaya With Sodium Borate3Product Code
- KOSAdhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer3Product Code
- KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium1Product Code
- KXRApplicator, Resin1Product Code
- KXWAdhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer1Product Code
- KXXAdhesive, Denture, Karaya And Ethylene-Oxide Homopolymer1Product Code
- KXYPolyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce3Product Code
- KZNScanner, Color2Product Code
- KZOInk, Arch Tracing1Product Code
- KZPSolution, Cement Dissolving2Product Code
- LBHVarnish, Cavity2Product Code
- K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)2Cleared 510(K)
- K241489ReminGel2Cleared 510(K)
- K241568CrystLCare™ PRO Biorestorative, Fluoride-Plus2Cleared 510(K)
- K242913Jasmate® Toothpaste2Cleared 510(K)
- K233768Papacarie Duo2Cleared 510(K)
- K231060ProMin Dental Desensitizing Gel2Cleared 510(K)
- K230333Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)2Cleared 510(K)
- K222891Dental Desensitizer2Cleared 510(K)
- K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment2Cleared 510(K)
- K220419Apapro Desensitizer2Cleared 510(K)
Show All 133 Submissions
- LPKBone Grafting Material, For Dental Bone Repair2Product Code
- LYCBone Grafting Material, Synthetic2Product Code
- LZDJoint, Temporomandibular, Implant3Product Code
- MMTResin, Root Canal Filling Containing Chloroform3Product Code
- MMUAdhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight3Product Code
- MPIGlenoid Fossa Prosthesis3Product Code
- MPJInterarticular Disc Prosthesis (Interpositional Implant)3Product Code
- MPLMandibular Condyle Prosthesis3Product Code
- MZWDental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief2Product Code
- NDPAccessories, Implant, Dental, Endosseous1Product Code
- NFEMaterials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation2Product Code
- NHAAbutment, Implant, Dental, Endosseous2Product Code
- NKJCushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter1Product Code
- NMEBur, Diamond Coated, Reprocessed1Product Code
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations2Product Code
- NPKBarrier, Synthetic, Intraoral2Product Code
- NPLBarrier, Animal Source, Intraoral2Product Code
- NPMBone Grafting Material, Animal Source2Product Code
- NPZBone Grafting Material, Dental, With Biologic Component3Product Code
- NQABiologic Material, Dental3Product Code
- NRQBlade-Form Endosseous Dental Implant2Product Code
- NUNBone Grafting Material, Human Source2Product Code
- NUXCleanser, Denture, Prescription1Product Code
- NYDEndodontic Kit2Product Code
- OATImplant, Endosseous, Orthodontic2Product Code
- NYEFixture Mount Kit1Product Code
- OFWRestorative Instrument And Component Tray2Product Code
- OFYDental Implant Surgical Tray1Product Code
- OIVDental Amalgam2Product Code
- PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish2Product Code
- PMEExternal Cleaning Solution2Product Code
- PNPDental Abutment Design Software For Dental Laboratory2Product Code
- POWCrown And Bridge, Long-Term Temporary, Resin2Product Code
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth2Product Code
- QJKIntraoral Camera2Product Code
- QRQNon-Irrigation Endosseous Dental Implant Drill Bits1Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K230333
- 510(k) Type
- Traditional
- Applicant
- Kettenbach GmbH & Co. KG
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/24/2023
- Days to Decision
- 167 days
- Submission Type
- Summary