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
- K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);2Cleared 510(K)
- K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2Cleared 510(K)
- K241924Elastic Impression Material2Cleared 510(K)
- K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator2Cleared 510(K)
- K233954Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu2Cleared 510(K)
- K223892DentMix VPS Impression Material2Cleared 510(K)
- K213175No Stress Impress2Cleared 510(K)
- K214086Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty2Cleared 510(K)
- K222741DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)2Cleared 510(K)
- K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)2Cleared 510(K)
- K221668Dental Impression Material2Cleared 510(K)
- K213890IMICRYL Impression Materials2Cleared 510(K)
- K220257Permadyne2Cleared 510(K)
- K220097PRESIDENT The Original2Cleared 510(K)
- K211489Dental Impression Material2Cleared 510(K)
- K203824VPS Impression Material2Cleared 510(K)
- K210041HySil Plus Impression Materials2Cleared 510(K)
- K201483Impression Material2Cleared 510(K)
- K201684A-Silicone for Bite Registration2Cleared 510(K)
- K201184Lascod Impression Materials2Cleared 510(K)
- K192941HySil Super Fast Impression Materials2Cleared 510(K)
- K190571StoneBite and StoneBite scan2Cleared 510(K)
- K191034VPS Impression Material2Cleared 510(K)
- K181604Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite2Cleared 510(K)
- K181236HySil Impression Materials2Cleared 510(K)
- K181011AIM22Cleared 510(K)
- K180565PEAK NS033CF, PEAK NS017CF2Cleared 510(K)
- K171562Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono2Cleared 510(K)
- K173318Rapid HB, Rapid LB, Rapid MB2Cleared 510(K)
- K170812HygePLUS Alginate Impression Material2Cleared 510(K)
- K170736HySil Impression Materials2Cleared 510(K)
- K152615Vonflex S2Cleared 510(K)
- K161774i-Sil2Cleared 510(K)
- K160097Image Fast Set, Image Regular Set2Cleared 510(K)
- K160441Identic and KromaFaze Alginate Dental Impression Materials2Cleared 510(K)
- K152826NoCord2Cleared 510(K)
- K152766CharmFlex2Cleared 510(K)
- K152861Aquasil Ultra + Smart Wetting Impression Material2Cleared 510(K)
- K152518Vonflex S Putty2Cleared 510(K)
- K152349Star+ VPS Scannable Impression Material2Cleared 510(K)
- K151535Cavex Cream Alginate2Cleared 510(K)
- K152180PEAK2Cleared 510(K)
- K151262Hyflex Heavy, Hyflex Mono, Hyflex Light2Cleared 510(K)
- K151150Elements2Cleared 510(K)
- K143575Accu-Dent XD Tray, Accu-Dent XD Syringe2Cleared 510(K)
- K143382DentiAnn Smart Sil2Cleared 510(K)
- K141092MARK32Cleared 510(K)
- K140966VONFLEX S BITE2Cleared 510(K)
- K132869SILDENT2Cleared 510(K)
- K140602FLASH PENTA MB QUICK, FLASH MB QUICK2Cleared 510(K)
- K133071ELASTIC IMPRESSION MATERIAL2Cleared 510(K)
- K140074HYGEDENT ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K134008MD-FLEX HEAVY BODY2Cleared 510(K)
- K133527SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT2Cleared 510(K)
- K133436FLASH AR; FLASH AR QUICK2Cleared 510(K)
- K133400FLASH BITE2Cleared 510(K)
- K132599SMILEBOND SYSTEM2Cleared 510(K)
- K131510POLYDIMETHYLSILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K130920CORRECT PLUS 12Cleared 510(K)
- K131404FLASH AR PENTA / FLASH AR PENTA QUICK2Cleared 510(K)
- K130869TAKE 1 ADVANCE2Cleared 510(K)
- K130647XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML2Cleared 510(K)
- K121824ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 22Cleared 510(K)
- K120914FLEXITIME FAST & SCAN LIGHT FLOW2Cleared 510(K)
- K113574FLEXITIME MONOPHASE PRO SCAN2Cleared 510(K)
- K120013TEMPSPAN CLEAR MATRIX2Cleared 510(K)
- K120521GC BLUE SILICONE2Cleared 510(K)
- K120438FLASH (DIFFERENT MATERIALS)2Cleared 510(K)
- K113406AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL2Cleared 510(K)
- K113279IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT2Cleared 510(K)
- K113263ARGES IMAGING CONTRAST SPRAY2Cleared 510(K)
- K110871FIT CHECKER ADVANCED2Cleared 510(K)
- K110092TAKE 1 ADVANCED RIGID TRAY2Cleared 510(K)
- K110378IMPRESSION COMPOUND2Cleared 510(K)
- K103586IOS FASTSCAN SPRAY2Cleared 510(K)
- K110050FIT TEST C&B2Cleared 510(K)
- K103346DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY2Cleared 510(K)
- K102836BONASIL A+ IMPRESSION MATERIALS2Cleared 510(K)
- K102770FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW2Cleared 510(K)
- K102739HYDROCOLOR 52Cleared 510(K)
- K103164VONFLEX HEAVY, VINFLEX LIGHT2Cleared 510(K)
- K101617FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL2Cleared 510(K)
- K092176TAKE 1 ADVANCED RIGID TRAY2Cleared 510(K)
- K091613TAKE 12Cleared 510(K)
- K092867IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT2Cleared 510(K)
- K092319STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 893872Cleared 510(K)
- K091494FLEXITIME FLOW2Cleared 510(K)
- K091267VONFLEX PUTTY2Cleared 510(K)
- K083739HYDRORISE AND HYDROSYSTEM2Cleared 510(K)
- K083701PANASIL INITIAL CONTACT AND PANASIL TRAY2Cleared 510(K)
- K082591FLEXITIME BITE2Cleared 510(K)
- K082560PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT2Cleared 510(K)
- K082157KETTOSIL AND SILGINAT2Cleared 510(K)
- K081017TEMPLATE AND COUNTER-FIT2Cleared 510(K)
- K081084COLORISE RIGID2Cleared 510(K)
- K081120FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS2Cleared 510(K)
- K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUS2Cleared 510(K)
- K080882CEREC OPTI SPRAY2Cleared 510(K)
- K080514PECD-01 AND PECD QUICK-012Cleared 510(K)
- K080130OCCLUFAST CAD2Cleared 510(K)
- K073475SYSTEM PLUS2Cleared 510(K)
- K073005ELITE GLASS2Cleared 510(K)
- K072577BISICO IMPRESSION SILICONES & ALGINATES2Cleared 510(K)
- K072622STANDOUT 22Cleared 510(K)
- K072245EMULATE ADVANCED2Cleared 510(K)
- K071192BLUGOO HD2Cleared 510(K)
- K070677COLORISE2Cleared 510(K)
- K070700FREEALGIN2Cleared 510(K)
- K062400IMPRESSIX, COLORCHANGE ALGINATE2Cleared 510(K)
- K060891VIRTUAL2Cleared 510(K)
- K061267SIMULATE, COLOR CHANGE ALGINATE2Cleared 510(K)
- K061427PRE-IMPRESSION CONDITIONING SOLUTION2Cleared 510(K)
- K053619COLORBITE2Cleared 510(K)
- K053427FRESH, DENTAL IMPRESSION MATERIAL2Cleared 510(K)
- K051933EXPASYL POWER APPLICATOR2Cleared 510(K)
- K052455IMPRESSIX2Cleared 510(K)
- K053014POLY SILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K053018POLY SILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K052409SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL2Cleared 510(K)
- K052090SPLASH! IMPRESSION MATERIAL DEVICE2Cleared 510(K)
- K051797FUTURE WASH/YPS2Cleared 510(K)
- K050417ELITE IMPLANT2Cleared 510(K)
- K051424HYDROGUM 52Cleared 510(K)
- K051535MODIFICATION TO:REGISTRADO X-TRA2Cleared 510(K)
- K051243JET BLUE BITE2Cleared 510(K)
- K051207CAVEX ORTHOTRACE2Cleared 510(K)
- K050604KERR VPS IMPRESSION MATERIAL2Cleared 510(K)
- K043493FUSION PUTTY TYPE2Cleared 510(K)
- K043054GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL2Cleared 510(K)
- K050013RETRACTOFOAM2Cleared 510(K)
- K043471FUSION FAST2Cleared 510(K)
- K043118HYDROGUM SOFT2Cleared 510(K)
- K042878FLEXITIME XTREME2Cleared 510(K)
- K043131TORPICALGIN2Cleared 510(K)
- K042860CORRECT DENTAL IMPRESSION MATERIAL2Cleared 510(K)
- K041398GC FUSION2Cleared 510(K)
- K041229MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)2Cleared 510(K)
- K041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL2Cleared 510(K)
- K040053PRECISION VPS IMPRESSION MATERIAL2Cleared 510(K)
- K032708PLASTALGIN AND PLASTALGIN ORTHO2Cleared 510(K)
- K032289FIT CHECKER II2Cleared 510(K)
- K031439ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)2Cleared 510(K)
- K032116TULIP COLORSWITCH2Cleared 510(K)
- K032001POLY Q (GARANT L, PENTA M, PENTA H)2Cleared 510(K)
- K031484STAND OUT2Cleared 510(K)
- K030776MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL2Cleared 510(K)
- K030414GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL2Cleared 510(K)
- K030318P2 POLYETHER2Cleared 510(K)
- K023751EXAJET2Cleared 510(K)
- K024041ZETAPLUS SOFT2Cleared 510(K)
- K024034OCCLUFAST ROCK2Cleared 510(K)
- K023466TULIP ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K022653ELITE MONOPHASE2Cleared 510(K)
- K022430ISO FUNCTIONAL2Cleared 510(K)
- K022066REGISTRADO X-TRA2Cleared 510(K)
- K021416AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL2Cleared 510(K)
- K021413AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL2Cleared 510(K)
- K021410AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL2Cleared 510(K)
- K020242EMULATE FAST SET AND EMULATE REGULAR SET2Cleared 510(K)
- K013859RHODIA BITE REGISTRATION MATERIAL2Cleared 510(K)
- K012767S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K012517CEREC3 VITABLOCKS2Cleared 510(K)
- K013336XANTALGIN CRONO2Cleared 510(K)
- K013237STATUSBLUE2Cleared 510(K)
- K013236LUXABITE2Cleared 510(K)
- K013129RHODIA DENTAL PUTTY IMPRESSION MATERIAL2Cleared 510(K)
- K013140RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL2Cleared 510(K)
- K012405EXTRUDE MODIFIED2Cleared 510(K)
- K011785NOVEL PRINT CYAN ALGINATES2Cleared 510(K)
- K011452CAVEX STABISIL2Cleared 510(K)
- K011419CAVEX COLORCHANGE2Cleared 510(K)
- K011450SILICONE IMPRESSION MATERIAL2Cleared 510(K)
- K010994TAKE ONE BITE MODIFIED2Cleared 510(K)
- K010926R-SI-LINE METAL-BITE2Cleared 510(K)
- K003808TAKE 12Cleared 510(K)
- K003650PERMLASTIC 32Cleared 510(K)
- K003930FLEXTIME MAGNUM 3602Cleared 510(K)
- K003426ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K001655PERMLASTIC 22Cleared 510(K)
- K001414KWIKKMODEL2Cleared 510(K)
- K001876TAKE 1 BITE2Cleared 510(K)
- K001218CORRECT PLUS2Cleared 510(K)
- K000686KROM-ALGINATE AND ALGINATE PLUS2Cleared 510(K)
- K994027ACTIVATOR PASTE2Cleared 510(K)
- K000878HONIGUM2Cleared 510(K)
- K000629FLEXTIME2Cleared 510(K)
- K000595DIMENSION PENTA L2Cleared 510(K)
- K000588DIMENSION GARANT L, DIMENSION GARANT L QUICK2Cleared 510(K)
- K000591DIMENSION PENTA H, DIMENSION PENTA H QUICK2Cleared 510(K)
- K994172CEREC 32Cleared 510(K)
- K994192IMPREGUM PENTA M MONOSOFT2Cleared 510(K)
- K994193IMPREGUM PENTA DUOSOFT2Cleared 510(K)
- K994190IMPREGUM GARANT L DUOSOFT2Cleared 510(K)
- K994077AROMA FINE (NORMAL AND FAST SET)2Cleared 510(K)
- K992001TRAY-LINK2Cleared 510(K)
- K992895IMPREGUM F2Cleared 510(K)
- K992897IMPREGUM PENTA2Cleared 510(K)
- K991631FASTRAY LC2Cleared 510(K)
- K991489ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)2Cleared 510(K)
- K991490ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)2Cleared 510(K)
- K991008DIMENSION BITE2Cleared 510(K)
- K991425XANTOPREN COMFORT2Cleared 510(K)
- K991221VESTOGUM2Cleared 510(K)
- K9831061ST IMPRESSION2Cleared 510(K)
- K982917B-SYSTEM SILICONE2Cleared 510(K)
- K981970ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI2Cleared 510(K)
- K9813253M M.G. MATERIAL2Cleared 510(K)
- K980968LONE STAR IMPRESSION SYSTEMS2Cleared 510(K)
- K981091NEOCOLLOID, ORTHOPRINT2Cleared 510(K)
- K980963HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)2Cleared 510(K)
- K980965SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K974894KROMATICA COLOR CHANGING ALGINATE2Cleared 510(K)
- K974704HYDROGUM2Cleared 510(K)
- K974231POSITION PENTA, POSITION PENTA QUICK2Cleared 510(K)
- K973781AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL2Cleared 510(K)
- K973782AQUASIL XLV SMART WETTING IMPRESSION MATERIAL2Cleared 510(K)
- K973694PROVIL NOVO2Cleared 510(K)
- K973343HYDROFLEX2Cleared 510(K)
- K972871GENESIS2Cleared 510(K)
- K970129TULIP2Cleared 510(K)
- K972276CEREC 2 CROWN SOFTWARE2Cleared 510(K)
- K972239ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING2Cleared 510(K)
- K972027ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)2Cleared 510(K)
- K971155MEMOREG2Cleared 510(K)
- K970656HYDROFLEX2Cleared 510(K)
- K965083SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET2Cleared 510(K)
- K970594KALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K970433AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL2Cleared 510(K)
- K965165CUTTERSIL COMFORT HARDENER2Cleared 510(K)
- K965163CUTTERSIL COMFORT2Cleared 510(K)
- K964692PERFECTIM2Cleared 510(K)
- K964177KROMALGIN IMPRESSION MATERIAL2Cleared 510(K)
- K964323CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K963609PHASE PLUS2Cleared 510(K)
- K9637663M PROPLUS SYSTEM2Cleared 510(K)
- K963205ALGINMAX, ORTHOCHROME2Cleared 510(K)
- K962680HYUNJAE DENTAL IMPRESSION MATERIALS2Cleared 510(K)
- K962741TRI-PHASIX CHROMATIC ALGINATE2Cleared 510(K)
- K952614JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL2Cleared 510(K)
- K954281PANASIL IMPRESSION MATERIAL2Cleared 510(K)
- K961201BOSWORTH IMPRESSION MATERIAL II2Cleared 510(K)
- K960547DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE2Cleared 510(K)
- K955932EXAFLEX IMPRESSION MATERIAL (MODIFICATION)2Cleared 510(K)
- K955892HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY2Cleared 510(K)
- K960063BOSWORTH IMPRESSION MATERIAL I2Cleared 510(K)
- K955465DEGUPRINT2Cleared 510(K)
- K955406SCAN WHITE 12 ML2Cleared 510(K)
- K954192IMPREGUM PENTA2Cleared 510(K)
- K954180MICROGLISS2Cleared 510(K)
- K954662THERMALASTIC/TRIPOLYVINALENE2Cleared 510(K)
- K935892INDURENT GEL2Cleared 510(K)
- K954223AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING2Cleared 510(K)
- K952728RETRAC2Cleared 510(K)
- K952930DENTRAY II PLUS TRAY ADHESIVE2Cleared 510(K)
- K935890ZETAPLUS (PUTTY)2Cleared 510(K)
- K952422ELASTIC IMPRESSION CREAM2Cleared 510(K)
- K935898HYDROGUM2Cleared 510(K)
- K953374PERMADYNE GARANT 2:12Cleared 510(K)
- K952693RAMITEC PENTA2Cleared 510(K)
- K953027PERMADYNE PENTA (HIGH & LOW VISCOSITY)2Cleared 510(K)
- K950299CEREC 22Cleared 510(K)
- K951237ALGI-BAND2Cleared 510(K)
- K951075S & C VINYL POLYSILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K945142POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)2Cleared 510(K)
- K943388GC SURFLEX F2Cleared 510(K)
- K935896THIXOFLEX2Cleared 510(K)
- K943574CAPTURE IMPRESSION MATERIAL2Cleared 510(K)
- K935886ELITE LIGHT BODY2Cleared 510(K)
- K935889OCCLUFAST2Cleared 510(K)
- K935888ELITE FAST LIGHT BODY2Cleared 510(K)
- K935887ELITE REGULAR BODY2Cleared 510(K)
- K935885ELITE FAST PUTTY SOFT2Cleared 510(K)
- K935884ELITE PUTTY SOFT2Cleared 510(K)
- K931242ELITE PUTTY HARD2Cleared 510(K)
- K943475ULTRA HYDROPHILIC ALGINAE2Cleared 510(K)
- K942219ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS2Cleared 510(K)
- K942666ORTHALGENAT IMPRESSION MATERIAL2Cleared 510(K)
- K940860CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS2Cleared 510(K)
- K940685PRETREATMENT SOLUTION2Cleared 510(K)
- K935151HYDROCOLLOID HEATING UNIT2Cleared 510(K)
- K940402SUPERGEL/SUPPRESSED DUST2Cleared 510(K)
- K940379EXTRUDE2Cleared 510(K)
- K940120ALPHA-DENT2Cleared 510(K)
- K936070TREND SET 2 PLUS2Cleared 510(K)
- K925746REPLICA2Cleared 510(K)
- K930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM2Cleared 510(K)
- K933206EXA BITE REGISTRATION MATERIAL2Cleared 510(K)
- K9215711ST IMPRESSION2Cleared 510(K)
- K932459FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL2Cleared 510(K)
- K926033VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD2Cleared 510(K)
- K925370TRIANGULAR JAW MICROLARYNGEAL FORCEPS2Cleared 510(K)
- K923202Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL2Cleared 510(K)
- K914178CORRECTED-V.P.S.2Cleared 510(K)
- K914437CORRECT-S.I.M.2Cleared 510(K)
- K895901VITA CEREC SET AND VITA CEREC BLOCS2Cleared 510(K)
- K912001CONVERTRAY, MODIFICATION2Cleared 510(K)
- K913583CONVERSIL FL AND CONVERSIL P2Cleared 510(K)
- K913537MEMOSIL C.D.2Cleared 510(K)
- K912485COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC2Cleared 510(K)
- K910360CUTTERSIL FUNCTION ACTIVATOR2Cleared 510(K)
- K910189PERFOURM PUTTY SOFT2Cleared 510(K)
- K910166CUTTERSIL XL2Cleared 510(K)
- K910165CUTTERSIL MUCOSA2Cleared 510(K)
- K905032MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K904927HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM2Cleared 510(K)
- K904482STAT.BR TM2Cleared 510(K)
- K903292ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS2Cleared 510(K)
- K901866DEGUFLEX (R) CS LIGHT2Cleared 510(K)
- K901865DEGUFLEX MONOPHASE2Cleared 510(K)
- K901867DEGUFLEX (R) CS PUTTY2Cleared 510(K)
- K901681FORMASIL(R)A POLYVINYL SILOXANE LINE2Cleared 510(K)
- K896468EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL2Cleared 510(K)
- K896786ZONAREX FINAL IMPRESSION COMPOUND2Cleared 510(K)
- K896785ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/2Cleared 510(K)
- K896539PERMADYNE GARANT LOW VISCOSITY2Cleared 510(K)
- K894282FIRST IMPRESSION TM2Cleared 510(K)
- K892412POLYETHER-RETARDER2Cleared 510(K)
- K892839PALGARAPID2Cleared 510(K)
- K894281FIRST IMPRESSION WITH CHLORHEXIDINE2Cleared 510(K)
- K890449PERMAGUM PUTTY SOFT & PERMAGUM GARRANT2Cleared 510(K)
- K892935RESOUND IMPRESSION MATERIAL2Cleared 510(K)
- K884166DICOR CERAMIC INLAY - NEW TECHNIC2Cleared 510(K)
- K883842DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.2Cleared 510(K)
- K884381PALGAFLEX AND PALGAFLEX-QUICK2Cleared 510(K)
- K882800COLTENE PRESIDENT JET REGULAR BODY2Cleared 510(K)
- K882690IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K881091OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K872745VINYL POLYSILOXANE IMPRESSION SYSTEM2Cleared 510(K)
- K871409VINYL POLYSILOXANE IMPRESSION SYSTEM2Cleared 510(K)
- K870011CONTRASYL IMPRESSION MATERIAL2Cleared 510(K)
- K870047COLTENE RAPID2Cleared 510(K)
- K863288HYDROPHILIC REPROSIL2Cleared 510(K)
- K862879NEW LIGHT-CURING IMPRESSION MATERIAL2Cleared 510(K)
- K860855SHUR GEL 42Cleared 510(K)
- K853089SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE2Cleared 510(K)
- K860911AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K860532KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL2Cleared 510(K)
- K860146POLYJEL N.F. (NEW FORMULA)2Cleared 510(K)
- K854106BAYSILEX2Cleared 510(K)
- K853529IMPREGUM-F2Cleared 510(K)
- K855111DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES2Cleared 510(K)
- K855112DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS2Cleared 510(K)
- K854855PROOF ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K844446BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.2Cleared 510(K)
- K851388SEPTOSIL SILICONE FOR PRECISION IMPRESSION2Cleared 510(K)
- K85146976 ELW BITE CHECKER SILICONE2Cleared 510(K)
- K842877ABSOLUTE VINYL POLYSILOXANE IMPRESS2Cleared 510(K)
- K850036COLTENE PRECISE2Cleared 510(K)
- K844329SURFLEX F2Cleared 510(K)
- K842324PERFOURM2Cleared 510(K)
- K843145TWO COMPONENT RTV VINYL SILICONE MATER2Cleared 510(K)
- K841490POLYSULFIDE CUSTOM TRAY MATERIAL2Cleared 510(K)
- K830044ODONTIC CENTRIC(BITE) REGIST. PASTE2Cleared 510(K)
- K830083SHUR GEL2Cleared 510(K)
- K821221DENTAL IMPRESSION MATERIAL2Cleared 510(K)
- K820489ULTRAFINE TRAY ADHESIVE2Cleared 510(K)
- K820216ULTRA-WET2Cleared 510(K)
- K820183SYBRON/KERR MIRROR 32Cleared 510(K)
- K820061REVERSIBLE HYDROCOLLOID IMPRESSION MAT2Cleared 510(K)
- K812679G-C FIT-CHECKER IMPRESSION MATERIAL2Cleared 510(K)
- K812406EXAFLEX IMPRESSION MATERIAL2Cleared 510(K)
- K811867SR-ALGICAP2Cleared 510(K)
- K811767COLTENE PRESIDENT IMPRESSION MATERIALS2Cleared 510(K)
- K811666COLTENE COLTEX/COLTOFLAX2Cleared 510(K)
- K811667COLTENE PRESSURE SPOT INDICATOR2Cleared 510(K)
- K811020REVERSIBLE HYDROCOLLOID IMPRESSION2Cleared 510(K)
- K810839SPOTAR2Cleared 510(K)
- K810825POLYVINYL SILICONE IMPRESSION MATERIAL2Cleared 510(K)
- K810523SR-IVOSEAL2Cleared 510(K)
- K802990ALGINATE/SILICONE CROWN & BRIDGE MATER2Cleared 510(K)
- K802882HYDROCOLLOID COMPATIBLE CREAM ALGINATE2Cleared 510(K)
- K802362ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K802189DENTLOID2Cleared 510(K)
- K801587ASH BLUEPRINT ALGINATE IMPRESSION MATER.2Cleared 510(K)
- K801380CROWN DELTA SILICONE IMPRESSION MATERIAL2Cleared 510(K)
- K800393POLY SULFIDE IMPRESSION PASTE W/CATALYST2Cleared 510(K)
- K800548SUPERSIL2Cleared 510(K)
- K800485VINYL POLYSILOXANE IMPRESSION MATERIAL2Cleared 510(K)
- K800031PERMADYNE POLYETHER RUBBER IMPRESSION2Cleared 510(K)
- K792363SILAGUM2Cleared 510(K)
- K790595DENTAL ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K790592IMPRESSION MATERIAL, RUBBER2Cleared 510(K)
- K782139ZYLOX2Cleared 510(K)
- K781689REFLECT IMPRESSION MATERIAL2Cleared 510(K)
- K781151REPROSIL2Cleared 510(K)
- K781083DENTAL SILICONE IMPRESSION MATERIAL2Cleared 510(K)
- K780778RTV SILICONE HAND KNEADABLE PUTTY2Cleared 510(K)
- K780164RTV DENTAL SILICONE2Cleared 510(K)
- K771938ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K771853PERMAGUM ADHESIVE2Cleared 510(K)
- K771627PERMAGUM2Cleared 510(K)
- K771248SILICONE IMPRESSION MATEOIAL2Cleared 510(K)
- K760981ALGINATE IMPRESSION MATERIAL2Cleared 510(K)
- K760753CUTTER JEL-ALGINATE IMPRESSION MAT.2Cleared 510(K)
- K760752CUTTER FLEX-SILICONE IMPRESSION MAT.2Cleared 510(K)
- K760755CUTTER SIL-SILICONE IMPRESSION MAT2Cleared 510(K)
- K760238IMPRESSION MATERIAL, TRIFLEX SILICONE2Cleared 510(K)
- K760240IMPRESSION MATERIAL, TRIFLEX SILICONE2Cleared 510(K)
- K760231IMPRESSION MATERIAL, DENTAL SILICON RTV2Cleared 510(K)
- K760226PASTE, ACCOE IMPRESSION2Cleared 510(K)
- K760225PUTTY, ACCOE2Cleared 510(K)
- 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
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- OphthalmicReview Panel
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- ToxicologyReview Panel
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- UnknownReview Panel
Hyflex Heavy, Hyflex Mono, Hyflex Light
- Page Type
- Cleared 510(K)
- 510(k) Number
- K151262
- 510(k) Type
- Traditional
- Applicant
- Osstem Implant Co., Ltd
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/21/2015
- Days to Decision
- 131 days
- Submission Type
- Summary