Anesthesiology
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- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- 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
- K253248Bright Cavity Liner2Cleared 510(K)
- K2302703M™ VitCal Liner/Base2Cleared 510(K)
- K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)2Cleared 510(K)
- K201799CleaniCal2Cleared 510(K)
- K202413LC ResinCal PC2Cleared 510(K)
- K191103Parkell Desensitizer Gel2Cleared 510(K)
- K180344TheraCal DC2Cleared 510(K)
- K143292TheraCal DC2Cleared 510(K)
- K150559Life Fast Set, Life Regular Set2Cleared 510(K)
- K141047LC CALCIUMHYDROXIDE LINER2Cleared 510(K)
- K134022BASE IT2Cleared 510(K)
- K131068TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID2Cleared 510(K)
- K122421TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID2Cleared 510(K)
- K120003NUCAL2Cleared 510(K)
- K113711LIME-LITE II2Cleared 510(K)
- K111668CAVIOS CAVITY LINER2Cleared 510(K)
- K063237THERACAL LC2Cleared 510(K)
- K060365APEXCAL2Cleared 510(K)
- K033521BISBLOCK2Cleared 510(K)
- K022025MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT2Cleared 510(K)
- K021146D/SENSE 1-STEP2Cleared 510(K)
- K012717LIFE 22Cleared 510(K)
- K010176CALEX CONDITIONER2Cleared 510(K)
- K001050CALCIJECT2Cleared 510(K)
- K983477SUPER SEAL2Cleared 510(K)
- K973539ROEKO CALCIUM HYDROXIDE POINTS2Cleared 510(K)
- K970113ULTRA-BLEND PLUS2Cleared 510(K)
- K970114ULTRACAL XS2Cleared 510(K)
- K964191CALCIUM HYDROXIDE MEDICAMENT2Cleared 510(K)
- K961708LIFE AND LIFE FAST SET2Cleared 510(K)
- K953524ULTRA-BLEND2Cleared 510(K)
- K953079LIMELIGHT2Cleared 510(K)
- K944945PULPDENT CALCIUM HYDROXIDE PREPARATIONS2Cleared 510(K)
- K944416LIFE2Cleared 510(K)
- K943372CALCIUM HYDROXIDE PASTE2Cleared 510(K)
- K941532BIOCALEX 6/92Cleared 510(K)
- K933507NEEDLETUBE SYRINGE CARTRTIDGE2Cleared 510(K)
- K933999STERIBASE (ACCUBASE)2Cleared 510(K)
- K931502VIVAGLASS LINER2Cleared 510(K)
- K926419CALCICUR2Cleared 510(K)
- K921408LIGHT CURE DENTIN AND LINER BASE PRODUCT LINE2Cleared 510(K)
- K924182CALCIMOL LC2Cleared 510(K)
- K923849CALCIMOL2Cleared 510(K)
- K922721VLC DYCAL II2Cleared 510(K)
- K920692SEPTOCALCINE ULTRA2Cleared 510(K)
- K913574SEPTOCAL CAVITY LINER2Cleared 510(K)
- K912495IONOSEAL2Cleared 510(K)
- K911244VLC GLASS IONOMER LINER2Cleared 510(K)
- K905723IONOSEAL2Cleared 510(K)
- K905724IONOBOND2Cleared 510(K)
- K904096PHOTAC-BOND2Cleared 510(K)
- K904097PHOTAC-BOND APLICAP2Cleared 510(K)
- K901999FUJI LINING CEMENT LIGHT CURE2Cleared 510(K)
- K897130INTERFACE - CAVITY LINER2Cleared 510(K)
- K896529BASIC CALCIUM HYDROXIDE LINER2Cleared 510(K)
- K895508CALASEPT PASTE2Cleared 510(K)
- K884949VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER2Cleared 510(K)
- K884245PERFECT CHOICE2Cleared 510(K)
- K882751GLASS IONOMER BASE2Cleared 510(K)
- K873882ALKALINER2Cleared 510(K)
- K874194PROTECT DROPS/SAME AS K8740702Cleared 510(K)
- K872147KERR CAVALITE2Cleared 510(K)
- K864053TUBULITEC LINER2Cleared 510(K)
- K851053TUBULITEC LINER2Cleared 510(K)
- K841910KERR SEALAPEX ROOT CANAL SEALER2Cleared 510(K)
- K833640HYDROXYLINE2Cleared 510(K)
- K831575NU-CAP CALCIUM HYDROX. PULP CAPPING2Cleared 510(K)
- K830112HYDROL2Cleared 510(K)
- K820215IMPROVED DYCAL2Cleared 510(K)
- K810266ETCHING GEL2Cleared 510(K)
- K802685REOLIT2Cleared 510(K)
- K801860S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX2Cleared 510(K)
- K791088MONOJECT PULP-CAPPING MATERIAL2Cleared 510(K)
- K781688LINER, CAVITY CALCIUM HYDROXIDE2Cleared 510(K)
- K780263SHIELD2Cleared 510(K)
- K780384IMPROVED DYCAL2Cleared 510(K)
- K760659CALCIPULPE2Cleared 510(K)
- 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
- 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
CALEX CONDITIONER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K010176
- 510(k) Type
- Traditional
- Applicant
- Stephen M Koral, Dmd
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/27/2001
- Days to Decision
- 68 days
- Submission Type
- Statement