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
- 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
- K041433BRIGHT GOLD XH2Cleared 510(K)
- K040436SIMIDUR SUPERIOR2Cleared 510(K)
- K022252STERNGOLD 1, MODEL 11277812Cleared 510(K)
- K022469ECO E42Cleared 510(K)
- K021367STERNGOLD 66, MODEL #11802302Cleared 510(K)
- K020192SIMIDUR S22Cleared 510(K)
- K020195SIMIDUR S1S2Cleared 510(K)
- K020194SIMIDUR KF PLUS2Cleared 510(K)
- K014042D.SIGN 842Cleared 510(K)
- K013809D.SIGN 592Cleared 510(K)
- K014082D.SIGN 53, MODEL NA10122042Cleared 510(K)
- K012841DUO PAL 6, ORDER-NO.: 21542Cleared 510(K)
- K012828PORTA SMK 82, MODEL 20322Cleared 510(K)
- K012840EURO 45, ORDER-NO.: 20642Cleared 510(K)
- K012303JEL-202Cleared 510(K)
- K003632DW 273 #12Cleared 510(K)
- K001469R&D PROJECT DW269#252Cleared 510(K)
- K000532JEL 152Cleared 510(K)
- K993475AUROFLUID M, ALLOY NO. 53152Cleared 510(K)
- K993505V-DELTA SPECIAL, ALLOY NO. 51542Cleared 510(K)
- K993506PAGALINOR 4 , ALLOY NO. 54402Cleared 510(K)
- K993474DELTAPAL, ALLOY NO. 51612Cleared 510(K)
- K984587ALLROUND-E (CODE NAME RD 1710)2Cleared 510(K)
- K990077D-SIGN III (R&D PROJECT DW264#7)2Cleared 510(K)
- K990078D-SIGN IV (R&D PROJECT DW265#37)2Cleared 510(K)
- K984451D-SIGN I (R&D PROJECT DW263 #24)2Cleared 510(K)
- K983081BEGOPAL 3002Cleared 510(K)
- K983078BEGOPAL2Cleared 510(K)
- K981257JELFINE-52 (CODE NAME RD-0901)2Cleared 510(K)
- K981247SILCAST (CODE NAME RD-0118)2Cleared 510(K)
- K981001ORION VESTA DENTAL ALLOY2Cleared 510(K)
- K981002ORION WX DENTAL ALLOY2Cleared 510(K)
- K980661CERA E DENTAL ALLOY2Cleared 510(K)
- K972945AURENORM 682Cleared 510(K)
- K973288STABILOR HN2Cleared 510(K)
- K972534ALFALLOY2Cleared 510(K)
- K972533VERA SOLDER2Cleared 510(K)
- K972683V-DELTA 4502Cleared 510(K)
- K970045SOLARO 332Cleared 510(K)
- K970044AUROFLUID 222Cleared 510(K)
- K964713SOLDER GPW2Cleared 510(K)
- K964705SOLDER GPY2Cleared 510(K)
- K964706SOLDER 6502Cleared 510(K)
- K964707SOLDER 5852Cleared 510(K)
- K962324STERNGOLD U-CPF METAL ALLOY (1067800)2Cleared 510(K)
- K962304STERNGOLD BIO-42Cleared 510(K)
- K962301STERNGOLD G-HARD METAL ALLOY2Cleared 510(K)
- K941625DW234 #292Cleared 510(K)
- K934757CU-FREE & LTA2Cleared 510(K)
- K935388CERAPALL 4CF2Cleared 510(K)
- K934773ARGELITE A2Cleared 510(K)
- K933563VS 1A2Cleared 510(K)
- K926147GOLD-PLATINUM BASED CASTING ALLOY2Cleared 510(K)
- K926146BIO C & B2Cleared 510(K)
- K925331CORRECT AND CORRECT FIT II2Cleared 510(K)
- K926145NUGOLD 2%2Cleared 510(K)
- K924292CERAPALL 6 -- MODIFIED2Cleared 510(K)
- K922958KB58-KF2Cleared 510(K)
- K922955ZENON PLUS2Cleared 510(K)
- K925273GDC 34452Cleared 510(K)
- K923644DW243-642Cleared 510(K)
- K922957PARAGON2Cleared 510(K)
- K922956KB40-KF2Cleared 510(K)
- K922447BENCHMARK III2Cleared 510(K)
- K922451LEGACY-XT2Cleared 510(K)
- K922450BENCHMARK C2Cleared 510(K)
- K922449PA-4002Cleared 510(K)
- K922448BENCHMARK I2Cleared 510(K)
- K922446ACCU-STAR2Cleared 510(K)
- K921445DEGUBOND PLUS2Cleared 510(K)
- K921419DEVA PLUS2Cleared 510(K)
- K920922GDC 33672Cleared 510(K)
- K920613DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL2Cleared 510(K)
- K915165ARGEBOND 77+2Cleared 510(K)
- K920887GDC-3338, DENTAL SOLDER ALLOY2Cleared 510(K)
- K920560DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL2Cleared 510(K)
- K914627PLATINUM FOIL PLATINUM MILING WAFER2Cleared 510(K)
- K913860ULTRACROWN(TM) PD ALLOY POST-SOLDER2Cleared 510(K)
- K913704ARGEBOND 802Cleared 510(K)
- K913069DW238 #228-04B2Cleared 510(K)
- K913068DW238 #228-34A2Cleared 510(K)
- K913070X-L (DW228-14A) AND X-LX (DW228-24A)2Cleared 510(K)
- K913232ULTRACROWN(TM) PD DENTAL ALLOY2Cleared 510(K)
- K912493DEGUBOND LITE2Cleared 510(K)
- K911674CERAPLUS2Cleared 510(K)
- K911669CERAPALL 62Cleared 510(K)
- K912307STANDARD S312Cleared 510(K)
- K912302VACU 22Cleared 510(K)
- K912308STANDARD S322Cleared 510(K)
- K912305STANDARD S32Cleared 510(K)
- K912195PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE2Cleared 510(K)
- K912194PA-393 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE2Cleared 510(K)
- K911671CERADELTA2Cleared 510(K)
- K912314800 SOLDER2Cleared 510(K)
- K912315V-DELTA S12Cleared 510(K)
- K911545V-DELTA2Cleared 510(K)
- K911677SELECTOR 32Cleared 510(K)
- K911675PAGALIN 22Cleared 510(K)
- K911668CERAPALL 22Cleared 510(K)
- K912300VS112Cleared 510(K)
- K912303STANDARD S12Cleared 510(K)
- K912304STANDARD S22Cleared 510(K)
- K912306STANDARD S42Cleared 510(K)
- K912309STANDARD S332Cleared 510(K)
- K912298VS12Cleared 510(K)
- K912299VS1B2Cleared 510(K)
- K911757MAXIBOND2Cleared 510(K)
- K911670CERAPALL2Cleared 510(K)
- K910467ARGIPLUS2Cleared 510(K)
- K904876DW2372Cleared 510(K)
- K903971ARGENCO 26B2Cleared 510(K)
- K903009ARGENCO III2Cleared 510(K)
- K903060ARGENCO 342Cleared 510(K)
- K902665ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE2Cleared 510(K)
- K902376DW231 DENTAL ALLOY2Cleared 510(K)
- K901099PROTOCOL (ALLOY)2Cleared 510(K)
- K890811RX APF (CASTING ALLOY)2Cleared 510(K)
- K883511ALBABOND E2Cleared 510(K)
- K883509HERAEUS DG 632Cleared 510(K)
- K883507HERAEUS C SPECIAL2Cleared 510(K)
- K883510DEGUPAL 42Cleared 510(K)
- K883512HERAEUS WHITE2Cleared 510(K)
- K874821LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL2Cleared 510(K)
- K873373SINTERLOY2Cleared 510(K)
- K871288GDC 1830 CASTING ALLOY2Cleared 510(K)
- K864162DEGUPAL2Cleared 510(K)
- K862856PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR2Cleared 510(K)
- K860964WHITE SILVER SOLDER AND YELLOW SILVER SOLDER2Cleared 510(K)
- K855182ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #652Cleared 510(K)
- K860439DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS2Cleared 510(K)
- K860299REALOR ALLOY2Cleared 510(K)
- K860119GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS)2Cleared 510(K)
- K852093ALLOY 72Cleared 510(K)
- K852347DENTAL CASTING ALLOY GDC 16862Cleared 510(K)
- K851648HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE2Cleared 510(K)
- K850699SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL2Cleared 510(K)
- K850193PORS-ON HF-SOLDER(PORCELAIN DENTAL ALLOYS)2Cleared 510(K)
- K850103GDC-1489 A CASTING ALLOY2Cleared 510(K)
- K850102GDC-1433 A CASTING ALLOY2Cleared 510(K)
- K850101GDC-1629 A CASTING ALLOY2Cleared 510(K)
- K840563RX C & B 202Cleared 510(K)
- K840561RX ELAN2Cleared 510(K)
- K840014CHEMODENT CERAMIC METAL2Cleared 510(K)
- K833774NATURELLE II & LITE II-N72-N74-L2Cleared 510(K)
- K833596GDC 1448 DEVELOPMENT NAME2Cleared 510(K)
- K833434CERAMCO * HIGH FUSING FOIL SOLDER2Cleared 510(K)
- K833445DEGUPLUS 22Cleared 510(K)
- K833050RX 902Cleared 510(K)
- K833049PALLADENT2Cleared 510(K)
- K832425GREAT LAKES PASTE SOLDER2Cleared 510(K)
- K832530DEVA 42Cleared 510(K)
- K832253X-7042Cleared 510(K)
- K831097CONCERTO2Cleared 510(K)
- K831096STROMA II2Cleared 510(K)
- K823084CHALLENGER2Cleared 510(K)
- K823100RX 912Cleared 510(K)
- K823097NATURELLE2Cleared 510(K)
- K822950RX UNIVERSAL2Cleared 510(K)
- K822419NEW CROWN AND BRIDGE ALLOY NO. DW1962Cleared 510(K)
- K82179882 ALLOY2Cleared 510(K)
- K821832DEGUCAST U2Cleared 510(K)
- K821590PORS-ON2Cleared 510(K)
- K821572DUALLOR 'R'2Cleared 510(K)
- K821510A THENIUM2Cleared 510(K)
- K821407DEVA M2Cleared 510(K)
- K821299CER-MATE2Cleared 510(K)
- K821022PRECIOUS METAL ALLOYS2Cleared 510(K)
- K820955BOND-ON2Cleared 510(K)
- K820530T-IV ELITE ALLOY2Cleared 510(K)
- K820433CLASS OF CASTING ALLOYS TYPE II OR ALTER2Cleared 510(K)
- K820434CLASS OF CASTING ALLOYS TYPE III OR ALT2Cleared 510(K)
- K820432CLASS OF CASTING ALLOYS TYPE I OR ALTER2Cleared 510(K)
- K820407CLASS OF PRECIOUS METAL CASTING ALLOYS2Cleared 510(K)
- K820408CLASS OF CASTING ALLOYS TYPE IV OR ALT2Cleared 510(K)
- K813418INZOMA NP2Cleared 510(K)
- K813200GDC-1136 CASTING ALLOY FOR PORCELAIN-FU2Cleared 510(K)
- K812101BAK-ON SP PORCELAIN ALLOY2Cleared 510(K)
- K811563PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS2Cleared 510(K)
- K810380HOWMEDICA T-III G ALLOY2Cleared 510(K)
- K801277GDC 9342Cleared 510(K)
- K801009HOWMEDICA WHITE C&B ALLOY2Cleared 510(K)
- K800951CASTA-LLOY2Cleared 510(K)
- K800994AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)2Cleared 510(K)
- K792274TEMPO2Cleared 510(K)
- K792008HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY2Cleared 510(K)
- K791973HOWMEDICA A-35 DENTAL ALLOY2Cleared 510(K)
- K791005CHEMODENT CERAMIC METAL2Cleared 510(K)
- K790641GDC-6852Cleared 510(K)
- K790097SALIVAN & SALIVAN BROWN2Cleared 510(K)
- K790096SALIVAN PARAEIGHT TOUGHNESS2Cleared 510(K)
- K771596WILL-CERAM W-32Cleared 510(K)
- K771145WILL-CERAM W-22Cleared 510(K)
- K760783BIOBOND-CROWN & BRIDGE CERAMIC BONDING2Cleared 510(K)
- K760379DENTAL AMALGAM ALLOY (SPHERICAL II)2Cleared 510(K)
- 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
JEL 15
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K000532
- 510(k) Type
- Traditional
- Applicant
- J.F. Jelenko & Co., Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/6/2000
- Days to Decision
- 49 days
- Submission Type
- Statement