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
- K123929BEGOPAL+2Cleared 510(K)
- K040180CONTINUM V2Cleared 510(K)
- K040179CONTINUM2Cleared 510(K)
- K033356VERASOFT ES2Cleared 510(K)
- K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST2Cleared 510(K)
- K032136WIROBOND C2Cleared 510(K)
- K031627NANO-TICROWN2Cleared 510(K)
- K030632PD CASTA-H2Cleared 510(K)
- K030416CERACAST-V2Cleared 510(K)
- K030161SUPERBOND2Cleared 510(K)
- K024214KAVO EVEREST TITANBLANK2Cleared 510(K)
- K023499GOLD CORE PLUS2Cleared 510(K)
- K023502JEWEL CAST PLUS2Cleared 510(K)
- K023477BIOLOY2Cleared 510(K)
- K021971CERALOY2Cleared 510(K)
- K021969CHROLOY2Cleared 510(K)
- K021968CERALOY SOLDER2Cleared 510(K)
- K021965CHROLOY SOLDER2Cleared 510(K)
- K0202534 ALL (DW286A)2Cleared 510(K)
- K020898D.SIGN 15 (DW286 B)2Cleared 510(K)
- K020183PISCES PLUS (DW286 C)2Cleared 510(K)
- K020062XERAFIT2Cleared 510(K)
- K011706FLEXICAST PRIME2Cleared 510(K)
- K011705SUPREMCAST2Cleared 510(K)
- K010381D.SIGN 302Cleared 510(K)
- K010069DURABOND NON-PRECIOUS CERAMIC ALLOY2Cleared 510(K)
- K003387AUROFILM NP2Cleared 510(K)
- K003509FLEXICAST2Cleared 510(K)
- K003039GOLD CORE II2Cleared 510(K)
- K003037JEWEL CAST III2Cleared 510(K)
- K002302SUPER 142Cleared 510(K)
- K002300SUPER 62Cleared 510(K)
- K002301SUPER 122Cleared 510(K)
- K002299SUPER 32Cleared 510(K)
- K002298SUPER 12Cleared 510(K)
- K001798DC TITAN2Cleared 510(K)
- K001383SUPREMCAST V2Cleared 510(K)
- K001269DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC2Cleared 510(K)
- K000981CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX2Cleared 510(K)
- K993572CERADIUM V NON-PRECIOUS CERAMIC ALLOY2Cleared 510(K)
- K992881HI BOND NON-PRECIOUS CERAMIC ALLOY2Cleared 510(K)
- K993344P10 SPECIAL2Cleared 510(K)
- K992705CERADIUM NON-PRECIOUS CERAMIC ALLOY2Cleared 510(K)
- K990235D-SIGN VI (R&D PROJECT DW266#9)2Cleared 510(K)
- K990182D-SIGN V (R&D PROJECT DW267#17)2Cleared 510(K)
- K984164JELBOND NP2Cleared 510(K)
- K982094VERABOND 22Cleared 510(K)
- K972971NPG + 22Cleared 510(K)
- K973567SOWELL COBALT-CHROME METAL ALLOY2Cleared 510(K)
- K973569SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY2Cleared 510(K)
- K973568SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY2Cleared 510(K)
- K973566SOWELL PATENTED NON-PRECIOUS METAL ALLOY2Cleared 510(K)
- K973265VERABOND 2V2Cleared 510(K)
- K972607PLATALLOY2Cleared 510(K)
- K972118VERA PDN2Cleared 510(K)
- K970205VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY2Cleared 510(K)
- K970827PRECISE2Cleared 510(K)
- K963891RX 96E2Cleared 510(K)
- K961720CERAMCO CROWNS AND BRIDGES2Cleared 510(K)
- K953594VULCAN2Cleared 510(K)
- K952866REMATITAN TITANIUM2Cleared 510(K)
- K952867REMANIUM:GM 700, GM 380, GM 800, GFH2Cleared 510(K)
- K952870REMANIUM: CS & G-SOFT2Cleared 510(K)
- K952865REMANIUM: 200,CS, 380, AND CD2Cleared 510(K)
- K950894SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)2Cleared 510(K)
- K950951NEOCAST C, V, S2Cleared 510(K)
- K945712VERABOND V2Cleared 510(K)
- K945714VERABOND III2Cleared 510(K)
- K945713VERABOND II2Cleared 510(K)
- K926165CERAMCO CROWNS AND BRIDGES2Cleared 510(K)
- K940749LPG 5/10, LPG 10/5, LPG 10/15 AND LPG 15/102Cleared 510(K)
- K932893VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY2Cleared 510(K)
- K934758R2+2Cleared 510(K)
- K935972ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)2Cleared 510(K)
- K935829ARGELOY PARTIAL (NON-PRECIOUS)2Cleared 510(K)
- K924716NICO DENTAL ALLOY2Cleared 510(K)
- K934768ARGELITE 81SF+2Cleared 510(K)
- K922954R1, R2, AND R1+2Cleared 510(K)
- K926347DUCERANIUM U2Cleared 510(K)
- K925579VERASOFT CASTING ALLOY2Cleared 510(K)
- K922790DEGUCAST 402Cleared 510(K)
- K915250WIL-PDS & WIL-PDI CASTING ALLOYS2Cleared 510(K)
- K920561DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.2Cleared 510(K)
- K915249VERA PDS & VERA PDI2Cleared 510(K)
- K915248LPG CASTING ALLOY2Cleared 510(K)
- K915247NPG III CASTING ALLOY2Cleared 510(K)
- K913857ROCATEC(R) -PLUS2Cleared 510(K)
- K911323FLUX-N-ALL2Cleared 510(K)
- K905034HD-4 CROWN & BRIDGE ALLOY2Cleared 510(K)
- K901552(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE2Cleared 510(K)
- K911821THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST2Cleared 510(K)
- K903538WIRON 99 DENTAL CASTING ALLOY2Cleared 510(K)
- K903008VIDENT 90 ALLOY AND VIDENT 95 ALLOY2Cleared 510(K)
- K900117STELLITE COBALT/CHROMIUM BASE METAL ALLOY2Cleared 510(K)
- K896501TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)2Cleared 510(K)
- K894085TALLADIUM TILITE CERAMIC ALLOY2Cleared 510(K)
- K884257LEVINIUM2Cleared 510(K)
- K882170RX ASPEN2Cleared 510(K)
- K880875VITALLIUM EQUIPOISE ALLOY2Cleared 510(K)
- K873661CHROME-COBALT BASE DENTAL ALLOY2Cleared 510(K)
- K864826A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)2Cleared 510(K)
- K863782NPG NONPRECIOUS CROWN AND BRIDGE ALLOY2Cleared 510(K)
- K862930PERFECT ONE2Cleared 510(K)
- K862822REXILLIUM N. B. F.2Cleared 510(K)
- K862499ULTRACAST2Cleared 510(K)
- K862870RESISTAL P2Cleared 510(K)
- K862667COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY2Cleared 510(K)
- K862417NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY2Cleared 510(K)
- K861820BIOSIL F2Cleared 510(K)
- K861787BIOSIL H2Cleared 510(K)
- K860437PARTIAL DENTURE ALLOY2Cleared 510(K)
- K860217NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)2Cleared 510(K)
- K854738SPARTAN SOLDER2Cleared 510(K)
- K854878H40 BASE METAL ALLOY2Cleared 510(K)
- K854495GRESCO N.P. DENTAL ALLOY2Cleared 510(K)
- K854285GDC 1453 CASTING ALLOY2Cleared 510(K)
- K853845ALLOY B2Cleared 510(K)
- K852895CERAMIC ALLOY NO. DW 1792Cleared 510(K)
- K853498PERFECT 102Cleared 510(K)
- K851515HERAENIUM CA2Cleared 510(K)
- K850084TRINDIUM-DENTAL MATERIAL2Cleared 510(K)
- K851569VERA BOND NON PERCIOUS CERAMIC ALLOY2Cleared 510(K)
- K844497AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY2Cleared 510(K)
- K844123RX CBY2Cleared 510(K)
- K844122RX CBG2Cleared 510(K)
- K842551BASE METAL ALLOY2Cleared 510(K)
- K842377MS NONPRECIOUS CROWN & BRIDGE ALLOY2Cleared 510(K)
- K841290STELDENT - DENTAL ALLOY2Cleared 510(K)
- K840562REX V2Cleared 510(K)
- K834560VITEX P.D.A2Cleared 510(K)
- K833512PARTIAL DENTURE ALLOY2Cleared 510(K)
- K833143REXILLIUM III2Cleared 510(K)
- K833145ZENITH2Cleared 510(K)
- K833144REX ALLOY2Cleared 510(K)
- K823008NOVAREX2Cleared 510(K)
- K822957PURCAST2Cleared 510(K)
- K822947NEPTUNE2Cleared 510(K)
- K822948RX BIOCAST2Cleared 510(K)
- K822896CAVIDRY2Cleared 510(K)
- K820328NICKEL-BASED DENTAL CASTING ALLOY2Cleared 510(K)
- K820049CERILLIUM2Cleared 510(K)
- K813243CERAL-BASE METAL ALLOY2Cleared 510(K)
- K811258BASE METAL ALLOY2Cleared 510(K)
- K811013SUMMAR NON-PRECIOUS, CERAMIC ALLOY2Cleared 510(K)
- K811407BA-932Cleared 510(K)
- K810594CRYSTALLOY-P2Cleared 510(K)
- K810611FULCAST/SUMMIT CASTING ALLOY2Cleared 510(K)
- K810521CO-SPAN 13.5 CASTING ALLOY2Cleared 510(K)
- K800371WILL CERAM LITE-CAST B2Cleared 510(K)
- K780642LITECAST SOLDER2Cleared 510(K)
- K780090DENTAL ALLOY2Cleared 510(K)
- K772256CROWN & BRIDGE ALLOY2Cleared 510(K)
- K771081LITECAST CERAMIC2Cleared 510(K)
- 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
ROCATEC(R) -PLUS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K913857
- 510(k) Type
- Traditional
- Applicant
- ESPE GMBH (US)
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/16/1991
- Days to Decision
- 111 days
- Submission Type
- Summary