Anesthesiology
Review Panel
- 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
- 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
- K250714FluoroDose Varnish2Cleared 510(K)
- 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)
- K200077BioMin Restore Plus2Cleared 510(K)
- K200614FiteBac Antimicrobial Cavity Cleanser2Cleared 510(K)
- K192381DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor2Cleared 510(K)
- K191453Cervitec F2Cleared 510(K)
- K190271FiteBac Cavity Cleanser2Cleared 510(K)
- K182917FluoroCal2Cleared 510(K)
- K181965Restore Toothpaste2Cleared 510(K)
- K160377V-varnish Premium2Cleared 510(K)
- K153334Oral-B 5% Sodium Fluoride Varnish2Cleared 510(K)
- K151302Clinpro Varnish2Cleared 510(K)
- K143155LISTERINE Sensitivity Defense Mouthrinse2Cleared 510(K)
- K140350VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL2Cleared 510(K)
- K131487FLUOR PROTECTOR S2Cleared 510(K)
- K141422PROFLUORO FLUORIDE VARNISH2Cleared 510(K)
- K140349STARBRIGHT 5% SODIUM FLUORIDE VARNISH2Cleared 510(K)
- K140481COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH2Cleared 510(K)
- K132426SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS2Cleared 510(K)
- K132109ENAMELAST2Cleared 510(K)
- K124025ALPHA-PRO WHITE VARNISH2Cleared 510(K)
- K131376SMARTCOAT 2.5% NAF VARNISH2Cleared 510(K)
- K123653SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)2Cleared 510(K)
- K122908PRG BARRIER COAT2Cleared 510(K)
- K122708REMESENSE FOR SENSITIVE TEETH2Cleared 510(K)
- K122331CAVITY VARNISH2Cleared 510(K)
- K120176SENZZZZZ AWAY2Cleared 510(K)
- K120109SUPER SEAL TOOTH DESENSITIZER2Cleared 510(K)
- K113146PCXX VARNISH2Cleared 510(K)
- K112946ACTIV VARNISH2Cleared 510(K)
- K103461COLGATE DESENSITIZING DENTAL CREAM2Cleared 510(K)
- K103160NUPRO MODEL 130169012Cleared 510(K)
- K102808MI VARNISH2Cleared 510(K)
- K100172TOKUYAMA SHIELD FORCE2Cleared 510(K)
- K100540ASCENT F-COAT MODEL: 006-000972Cleared 510(K)
- K100503PULPDENT COPAL VARNISH WITH FLUORIDE2Cleared 510(K)
- K093620PULPDENT FLUORIDE VARNISH2Cleared 510(K)
- K092141VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH2Cleared 510(K)
- K093575GLUMA DESENSITIZER POWER GEL2Cleared 510(K)
- K090519VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 122472Cleared 510(K)
- K082594REMESENSE2Cleared 510(K)
- K090597FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH2Cleared 510(K)
- K083036VOCO PROFLUORID L2Cleared 510(K)
- K082198DURASHIELD PLUS2Cleared 510(K)
- K082071ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT2Cleared 510(K)
- K080814VOCO PROFLUORID VARNISH2Cleared 510(K)
- K080228ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH2Cleared 510(K)
- K073061THE PROXIVENT KIT2Cleared 510(K)
- K080249FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S45052Cleared 510(K)
- K073117DENTIN DESENSITIZER AGENT2Cleared 510(K)
- K072342SULTAN TOOTH ROOT DESENSITIZER2Cleared 510(K)
- K072338CERVITEC PLUS2Cleared 510(K)
- K061438ULTRAEZ DESENSITIZING GEL2Cleared 510(K)
- K070070ASCENT DENTAL CLEANSER2Cleared 510(K)
- K071267PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN2Cleared 510(K)
- K070289ACQUASEAL BENZ2Cleared 510(K)
- K062176RELIEF ACP ORAL CARE GEL2Cleared 510(K)
- K062683ENAMEL PRO VARNISH2Cleared 510(K)
- K061359DENSHIELD TREATMENT FOR SENSITIVE TEETH2Cleared 510(K)
- K052263MULTIPLE (TOOTH DESENSITIZER)2Cleared 510(K)
- K051750FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 45022Cleared 510(K)
- K050486PROTECT TOOTH DESENSITIZER2Cleared 510(K)
- K040858ORALIEF THERAPY FOR SENSITIVE TEETH2Cleared 510(K)
- K040473ORAVIVE TOOTH REVITALIZING PASTE2Cleared 510(K)
- K040098VARNISHAMERICA2Cleared 510(K)
- K033295BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN2Cleared 510(K)
- K030922VIVASENS2Cleared 510(K)
- K031932FLUORIDE VARNISH2Cleared 510(K)
- K030488FLUORILAQ2Cleared 510(K)
- K023671AQUEOUS ACRYLIC DISPERSION 28% W/W2Cleared 510(K)
- K021131CHLORAPREP2Cleared 510(K)
- K021805SEAL & PROTECT PROTECTIVE SEALANT2Cleared 510(K)
- K013411PULPDENT CAVITY PREPARATION IV2Cleared 510(K)
- K010957QUELL DESENSITIZER2Cleared 510(K)
- K010255CAVITY VARNISH2Cleared 510(K)
- K003482PROCLUDE-SENSITIVE2Cleared 510(K)
- K002581DURAGARD SODIUM FLUORIDE VARNISH2Cleared 510(K)
- K994180PULPDENT CAVITY PREPARATION III2Cleared 510(K)
- K994181PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE2Cleared 510(K)
- K994182PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE2Cleared 510(K)
- K992822SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE2Cleared 510(K)
- K990779HEMASEAL & CIDE2Cleared 510(K)
- K992629D/SENSE II (GREEN-OR) DENTIN DESENSITIZER2Cleared 510(K)
- K982915SCI-PHARM DFV VARNISH2Cleared 510(K)
- K983305SCI-PHARM DESENSITIZING VARNISH2Cleared 510(K)
- K981972GREEN-OR DENTIN DESENSITIZER2Cleared 510(K)
- K974202PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS2Cleared 510(K)
- K974398PULPDENT CAVITY VARNISH2Cleared 510(K)
- K973919CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)2Cleared 510(K)
- K963979ULTRADENT UNIVERSAL DENTIN SEALANT2Cleared 510(K)
- K961893DURAFLOR2Cleared 510(K)
- K955521ALPHA-DENT COPAL CAVITY VARNISH2Cleared 510(K)
- K953168ULTRACID F DISINFECTING SOLUTION2Cleared 510(K)
- K953167ULTRACID DISINFECTING SOLOUTION2Cleared 510(K)
- K945794DURAPHAT2Cleared 510(K)
- K946032FLUOR PROTECTOR2Cleared 510(K)
- K944934POLYURETHANE SOLUTION 29% W/W2Cleared 510(K)
- K933505BOSWORTH COPALIONER2Cleared 510(K)
- K925375CONSEPSIS SCRUB2Cleared 510(K)
- K924982CONSEPSIS(TM)2Cleared 510(K)
- K931096DURAFLOR2Cleared 510(K)
- K924827MICRODOSE POTASSIUM OXYLATE2Cleared 510(K)
- K901915DENTIN PROTECTOR2Cleared 510(K)
- K901049COPAL VARNISH2Cleared 510(K)
- K900946UNIVERSUM2Cleared 510(K)
- K880741ESPE VARNISH2Cleared 510(K)
- K881026CONTAC, A DENTIN SEALANT2Cleared 510(K)
- K864051TUBULICID RED LABEL2Cleared 510(K)
- K864050TUBULICID BLUE LABEL2Cleared 510(K)
- K864052TUBULITEC PRIMER2Cleared 510(K)
- K860633FLUOROSEAL, DENTIN SEALER AND CAVITY LINER2Cleared 510(K)
- K852755UNIVAR UNIVERSAL DENTIN VARNISH2Cleared 510(K)
- K852756TELEDYNE GETZ BARRIER-DENTIN SEALER2Cleared 510(K)
- K851052TUBULITEC PRIMER2Cleared 510(K)
- K851030TEMREX-DENTIN VARNISH2Cleared 510(K)
- K833701ACA THYROXINE ANALYTICAL TEST PACK2Cleared 510(K)
- K832497CAVITY CLEANSER2Cleared 510(K)
- K812550BEAUCAV2Cleared 510(K)
- K812548COBEAU2Cleared 510(K)
- K810913CAVITY VARNISH2Cleared 510(K)
- K802926SCI-PHARM UNIVERSAL CAVITY VARNISH2Cleared 510(K)
- K801047PLY LESIVE2Cleared 510(K)
- K800438DENTAL CAVITY VARNISH, CONCENTRATED2Cleared 510(K)
- K760982DENTAL VARNISH2Cleared 510(K)
- K760660HYDROL2Cleared 510(K)
- 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
ENAMELAST
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K132109
- 510(k) Type
- Traditional
- Applicant
- Ultradent Products Inc. / Oratech, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/1/2013
- Days to Decision
- 116 days
- Submission Type
- Summary