Anesthesiology
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- 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
- K243951TEMP MASTER, PMMA-based dental resin2Cleared 510(K)
- K242559Digital Temp2Cleared 510(K)
- K231859PrimmaArt2Cleared 510(K)
- K240538Premium Teeth Resin2Cleared 510(K)
- K241226Fixtemp® C&B 4:12Cleared 510(K)
- K233868dima Print Teeth & Temp2Cleared 510(K)
- K223706PMMA BLOCK2Cleared 510(K)
- K223477PMMA Blocks for Dental Use2Cleared 510(K)
- K202965CURA-Temp2Cleared 510(K)
- K214071Hexa-Temp2Cleared 510(K)
- K213643UltraPrint-Dental Temp C&B UV2Cleared 510(K)
- K210817C&B 5.0 Hybrid2Cleared 510(K)
- K211101E-Temp2Cleared 510(K)
- K201563PuRE PMMA Disc2Cleared 510(K)
- K190217Aidite PMMA2Cleared 510(K)
- K201827GR-17 Resin System2Cleared 510(K)
- K201683PMMA Block2Cleared 510(K)
- K200273FREEPRINT temp2Cleared 510(K)
- K201090Structur CAD2Cleared 510(K)
- K192830Bright Temporary C&B2Cleared 510(K)
- K200039P pro Crown & Bridge2Cleared 510(K)
- K193113GC Temp Print2Cleared 510(K)
- K200676ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA2Cleared 510(K)
- K193553VarseoSmile Temp2Cleared 510(K)
- K191590AA temp temporary restoration 3D printing photoreactive resin2Cleared 510(K)
- K192158DiaTemp2Cleared 510(K)
- K192022DiaTemp Flow2Cleared 510(K)
- K192806DENTCA Crown and Bridge2Cleared 510(K)
- K192153Portux CAD/CAM Disc2Cleared 510(K)
- K191843Ceramill A-Temp2Cleared 510(K)
- K191619TurboTemp EZ2Cleared 510(K)
- K190930SmarTemp X12Cleared 510(K)
- K190724MD-Temp Plus2Cleared 510(K)
- K183337LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D22Cleared 510(K)
- K182065EVOLUX CAD/CAM PMMA BLOCKS2Cleared 510(K)
- K180578Harvest Dental Polymer Blocks2Cleared 510(K)
- K180657Resin for Temporary Crown & Bridge2Cleared 510(K)
- K180562TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT2Cleared 510(K)
- K171729Fixtemp C&B2Cleared 510(K)
- K172281PuRE PMMA Disc2Cleared 510(K)
- K153490DD medical polymers2Cleared 510(K)
- K152443Vericore Gradient Temporary Disc2Cleared 510(K)
- K153753TelioCAD Multi2Cleared 510(K)
- K152215DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR2Cleared 510(K)
- K151764YAMAHACHI PMMA DISKS2Cleared 510(K)
- K151144SuPro 1002Cleared 510(K)
- K150432IDODENTINE DISC, IDODENTINE BLOCK2Cleared 510(K)
- K142371Luminesse PMMA2Cleared 510(K)
- K133268TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS2Cleared 510(K)
- K141421PMMA BLOCK2Cleared 510(K)
- K141562MSN-0062Cleared 510(K)
- K140894ARGEN PMMA2Cleared 510(K)
- K132937HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)2Cleared 510(K)
- K131664COPRA TEMP PMMA-DISK2Cleared 510(K)
- K123638PEKKTON IVORY2Cleared 510(K)
- K122039KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B2Cleared 510(K)
- K122025BRIGHTGLASS BRIGHTGLASS M2Cleared 510(K)
- K112967PMMA CAD/CAM DISC2Cleared 510(K)
- K120784TUFF-TEMP 2.02Cleared 510(K)
- K120779STRUCTUR 32Cleared 510(K)
- K112186FIBER DISK AND BLOCK2Cleared 510(K)
- K111666EVADYNE TEMPORARY CROWN AND BRIDGE RESIN2Cleared 510(K)
- K102917FIXTEMP C&B2Cleared 510(K)
- K110747TEMPFLEX2Cleared 510(K)
- K103514PRO-V COAT2Cleared 510(K)
- K110484SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL2Cleared 510(K)
- K102776EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM2Cleared 510(K)
- K103379TELIO CS INLAY & TELIO CS ONLAY2Cleared 510(K)
- K103474ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)2Cleared 510(K)
- K102753TURBO TEMP 32Cleared 510(K)
- K102341VIPI BLOCK2Cleared 510(K)
- K101710LUXATEMP ULTRA /STAR2Cleared 510(K)
- K101814DIRECT CROWN NATURAL 12Cleared 510(K)
- K093708TELIO CAD2Cleared 510(K)
- K093380MIZZY EXPRESS2Cleared 510(K)
- K091894TEMPORARY C&B COMPOSITE2Cleared 510(K)
- K083195MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN2Cleared 510(K)
- K082700TEMPORARY COLD.V AND SELF-CURE DENTINE2Cleared 510(K)
- K081810PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL2Cleared 510(K)
- K081705LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN2Cleared 510(K)
- K080556ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES2Cleared 510(K)
- K080311MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM2Cleared 510(K)
- K073106UNIFAST III2Cleared 510(K)
- K080182ZENO PMMA DISC2Cleared 510(K)
- K073263PRO-V2Cleared 510(K)
- K073296TEMPXN282Cleared 510(K)
- K071548WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED2Cleared 510(K)
- K070991VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-43102Cleared 510(K)
- K063624KAVO EVEREST C-TEMP2Cleared 510(K)
- K061809ARTEGRAL IMCROWN2Cleared 510(K)
- K061530MD-TEMP2Cleared 510(K)
- K061264TEMPFX ESTHETIC PROVISIONAL SYSTEM2Cleared 510(K)
- K060881TEMPORARY CROWN & BRIDGE RESIN2Cleared 510(K)
- K052800PROVISIONAL INLAY/ONLAY KIT2Cleared 510(K)
- K060293TEMPORARY CROWN AND BRIDGE MATERIAL2Cleared 510(K)
- K052781BREFORMANCE2Cleared 510(K)
- K042820SYSTEMP.C&B PLUS2Cleared 510(K)
- K041886PROVISO2Cleared 510(K)
- K040951SR ADORO2Cleared 510(K)
- K041098COOL TEMP NATURAL2Cleared 510(K)
- K040769STRUCTUR 2 SC2Cleared 510(K)
- K033227LUXAFORM PLUS2Cleared 510(K)
- K033432LEXATITE QUICK ACRYLIC2Cleared 510(K)
- K033022PROTEMP 3 GARANT2Cleared 510(K)
- K031476FILL-IN2Cleared 510(K)
- K024282ACRYLIC2Cleared 510(K)
- K023079NEW OUTLINE2Cleared 510(K)
- K022030POLY-CARB2Cleared 510(K)
- K013869SR IVOCRON2Cleared 510(K)
- K021457FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL2Cleared 510(K)
- K020178BELLEGLASS HP MODELING GEL2Cleared 510(K)
- K020157TEMPORARY CROWN AND BRIDGE MATERIAL2Cleared 510(K)
- K020092TEMPHASE2Cleared 510(K)
- K013895TEMPFIL2Cleared 510(K)
- K013674LUXATEMP/LUXATEMP SOLAR/INSTATEMP2Cleared 510(K)
- K012360LC TEMPORARY FILLING2Cleared 510(K)
- K010012LC PROVIFILL2Cleared 510(K)
- K003817PATTERN RESIN2Cleared 510(K)
- K003374FERMIT PLUS2Cleared 510(K)
- K003377FERMIT N PLUS2Cleared 510(K)
- K001884DIRECT CROWN2Cleared 510(K)
- K002364PROTEMP H2Cleared 510(K)
- K001309HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 982502Cleared 510(K)
- K0011143M QUIK TEMP TEMPORIZATION MATERIAL2Cleared 510(K)
- K000894C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO2Cleared 510(K)
- K000346EZ CONNECT2Cleared 510(K)
- K000951LUXAFORM2Cleared 510(K)
- K994012TEMPOFIT, MODEL 026932Cleared 510(K)
- K991564JELTEMP2Cleared 510(K)
- K991270SMARTEMP2Cleared 510(K)
- K980799HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL2Cleared 510(K)
- K982459TEMPFIL F - 22Cleared 510(K)
- K972198DENT-TEMP ACRYLIC2Cleared 510(K)
- K9701683M QUIKPLUS SYSTEM2Cleared 510(K)
- K964981TEMPFIL C&B2Cleared 510(K)
- K964691TCB TEMPORARY CROWN AND BRIDGE MATERIAL2Cleared 510(K)
- K963786TEMPFIL F2Cleared 510(K)
- K961199BOSWORTH TEMPORARY RESIN2Cleared 510(K)
- K961198BOSWORTH CH I2Cleared 510(K)
- K954976POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)2Cleared 510(K)
- K960938PROV-KB2Cleared 510(K)
- K960122ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL2Cleared 510(K)
- K955331BELLEGLASHP2Cleared 510(K)
- K950203PROTEMP(R) GARANT2Cleared 510(K)
- K9449813M TEMPCARE LIGHT CURE TEMPORARY SYSTEM2Cleared 510(K)
- K942670GC PATTERN RESIN2Cleared 510(K)
- K941849PROVIPONT C&B2Cleared 510(K)
- K924830LUXATEMP AUTOMIX2Cleared 510(K)
- K941124STRUCTUR 22Cleared 510(K)
- K935960GC TEMPRON2Cleared 510(K)
- K9350413M TEMPORARY CROWN & BRIDGE MATERIAL2Cleared 510(K)
- K934978FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL2Cleared 510(K)
- K934283DENTALON PLUS MODIFICATION2Cleared 510(K)
- K932034PALAVIT 55 AND DENTACOLOR CONNECTOR2Cleared 510(K)
- K922559ACUFEX ENDOFIX BUTTON2Cleared 510(K)
- K915466SEPTOPACK TEMPORARY FILLING2Cleared 510(K)
- K904251NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL2Cleared 510(K)
- K903317DENTALON PLUS2Cleared 510(K)
- K900389TEMPORARY CROWN MATRIX BUTTONS2Cleared 510(K)
- K901077PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)2Cleared 510(K)
- K900068ARISTEE (RESIN, CROWN AND BRIDGES)2Cleared 510(K)
- K900436PROTEMP II2Cleared 510(K)
- K892710ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)2Cleared 510(K)
- K890829UNIFAST LC2Cleared 510(K)
- K875133CAVIT-W2Cleared 510(K)
- K875145MAR BOND2Cleared 510(K)
- K853092PSP C & B TEMP2Cleared 510(K)
- K853052INTEGRITY2Cleared 510(K)
- K833261INTERIM TEMP. CROWN & BRIDGE RESIN2Cleared 510(K)
- K831077DENTALON2Cleared 510(K)
- K831294SOLARCRY/TEMPORARY CROWN & BRIDGE MAT2Cleared 510(K)
- K822722CROWN S BRIDGE RESIN2Cleared 510(K)
- K822452PROTEMP2Cleared 510(K)
- K820456CROWN & BRIDGE RESIN FOR FABRICAT/DE2Cleared 510(K)
- K802679SILANIT2Cleared 510(K)
- K802489REIGNING CROWN BRIDGE2Cleared 510(K)
- K800828MYERSON'S SPECIAL CROWN & BRIDGE RESIN2Cleared 510(K)
- K781244TEMP. CROWN MSTERIAL FOR TEETH2Cleared 510(K)
- K772211TEMP. ACRYLIC2Cleared 510(K)
- K771602MYERSONS SPEC. CROWN & BRIDGE RESIN2Cleared 510(K)
- K771530TEMP. CROWN ACRYLIC RESIN2Cleared 510(K)
- K771527ACCU. CROWN COLD CURE2Cleared 510(K)
- K771254ACCU. CROWN COLD CURE2Cleared 510(K)
- K771257ACRY TEMP2Cleared 510(K)
- 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
- 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
PuRE PMMA Disc
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201563
- 510(k) Type
- Special
- Applicant
- Quest Dental USA Corp.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/9/2021
- Days to Decision
- 303 days
- Submission Type
- Summary