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
- K250267Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)2Cleared 510(K)
- K242713Any-Com Bulk2Cleared 510(K)
- K242572TopCEM-Try in Veneer Try-in Gel2Cleared 510(K)
- K2437203Delta UNlimited2Cleared 510(K)
- K242816Quantium2Cleared 510(K)
- K233273C&B Ceramic; C&B Permanent; C&B Interim2Cleared 510(K)
- K241131edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK2Cleared 510(K)
- K232994Vittra APS Unique Flow2Cleared 510(K)
- K242097DenMat Bulk Fill Composite2Cleared 510(K)
- K241673Denture Base Resin (PN-Denture (Red, White))2Cleared 510(K)
- K242014Jet Flow Bulk2Cleared 510(K)
- K242277Crown HT2Cleared 510(K)
- K241147Any-Com2Cleared 510(K)
- K240660Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active2Cleared 510(K)
- K232559C&B NFH Hybrid2Cleared 510(K)
- K240823els extra low shrinkage® composite & els extra low shrinkage® flow2Cleared 510(K)
- K231142Temporis, Irix Plus2Cleared 510(K)
- K240694FORMA Composite (Shade A3D)2Cleared 510(K)
- K240112Light Cure Composite2Cleared 510(K)
- K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT2Cleared 510(K)
- K233082TopCEM Dual Cure Resin Cement2Cleared 510(K)
- K232050saremco print BRIDGETEC2Cleared 510(K)
- K233596VarseoSmile TriniQ2Cleared 510(K)
- K233502TERA HARZ II2Cleared 510(K)
- K230644Signum opaque F2Cleared 510(K)
- K231523EsCom2502Cleared 510(K)
- K230877Admira Fusion 52Cleared 510(K)
- K223742Dental Ceramic Blocks2Cleared 510(K)
- K222445LC ChromeFlow2Cleared 510(K)
- K222623Digital Crown2Cleared 510(K)
- K223632Premier's MultiMatch Universal Chameleon Restorative Composite2Cleared 510(K)
- K222581Stela Automix System2Cleared 510(K)
- K222583Stela Capsule System2Cleared 510(K)
- K221510TrusFIL-Flow Flowable Composite Restorative2Cleared 510(K)
- K222435Renamel® Microhybrid ;Renamel® Flowable Microhybrid2Cleared 510(K)
- K222877FREEPRINT crown2Cleared 510(K)
- K213339DENU Composite Resin, DENU Flow Resin2Cleared 510(K)
- K222723AMBARINO High-Class2Cleared 510(K)
- K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow2Cleared 510(K)
- K220329G-CAM2Cleared 510(K)
- K220077IMICRYL Composite, Composite Flow Materials2Cleared 510(K)
- K221909J-Temp2Cleared 510(K)
- K2216953M Filtek Supreme Flowable Restorative2Cleared 510(K)
- K202920OptiComp2Cleared 510(K)
- K220605Venus Bulk Flow ONE2Cleared 510(K)
- K213343Saremco Print CROWNTEC2Cleared 510(K)
- K2118043Delta Crown2Cleared 510(K)
- K211345C-30 Crown Kit2Cleared 510(K)
- K210231Vittra APS Unique2Cleared 510(K)
- K202063TrusFIL Universal Composite Restorative2Cleared 510(K)
- K210045ACTIVA PRESTO PACK2Cleared 510(K)
- K210412Pac-Dent Ceramic Nanohybrid Resin2Cleared 510(K)
- K210349TKO Composite Bite Turbo Gel2Cleared 510(K)
- K202846TERA HARZ2Cleared 510(K)
- K210421Diafil & Diafil Capsule2Cleared 510(K)
- K211259Renamel Bulkfill2Cleared 510(K)
- K210977E-Dent 10002Cleared 510(K)
- K200470Shofu Block HC Hard2Cleared 510(K)
- K203598Omnichroma Flow Bulk2Cleared 510(K)
- K201707Opallis, Opallis Flow2Cleared 510(K)
- K200155Bright High Flow2Cleared 510(K)
- K200156Bright Low Flow2Cleared 510(K)
- K201795Transcend2Cleared 510(K)
- K193537Omnichroma Flow2Cleared 510(K)
- K201010Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite2Cleared 510(K)
- K201307VisCalor2Cleared 510(K)
- K201668VarseoSmile Crown plus2Cleared 510(K)
- K193496CharmFil2Cleared 510(K)
- K190139Zircos-Com2Cleared 510(K)
- K200294GrandioSO Light Flow2Cleared 510(K)
- K192284DiaFil Flow2Cleared 510(K)
- K192510DIAFIL & DIAFIL Capsule2Cleared 510(K)
- K191991Ezfil2Cleared 510(K)
- K191389Allcem Veneer APS2Cleared 510(K)
- K192178R&D Series Nova Compo N2Cleared 510(K)
- K191306Llis, Vittra APS2Cleared 510(K)
- K192260everX Flow2Cleared 510(K)
- K191980CLEARFIL MAJESTY ES Flow2Cleared 510(K)
- K191385BRILLIANT COMPONEER2Cleared 510(K)
- K182921Infinix Universal Composite2Cleared 510(K)
- K190758Opus Bulk Fill APS, Opus Bulk Fill Flow APS2Cleared 510(K)
- K182714Novidia Bulk Fill Flow Composite2Cleared 510(K)
- K182780XP Composite2Cleared 510(K)
- K182580Novidia Flowable Composite2Cleared 510(K)
- K190597BRILLIANT EverGlow Flow2Cleared 510(K)
- K182430CLEARFIL MAJESTY IC2Cleared 510(K)
- K182778LC GLOSSFILL XR2Cleared 510(K)
- K190453VisCalor bulk2Cleared 510(K)
- K183380Tetric PowerFill2Cleared 510(K)
- K182869Fit SA2Cleared 510(K)
- K1834763M Filtek Universal Restorative2Cleared 510(K)
- K182296HyperFil-LV2Cleared 510(K)
- K182288TPH Spectra ST Flowable Composite Restorative2Cleared 510(K)
- K181689Nexcomp2Cleared 510(K)
- K180463Apoller Flow Light Cure Flowable Composite2Cleared 510(K)
- K181312GrandioSO x-tra2Cleared 510(K)
- K181500BRILLIANT Crios2Cleared 510(K)
- K180613Estelite Universal Flow2Cleared 510(K)
- K172952Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit2Cleared 510(K)
- K181484Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue2Cleared 510(K)
- K180649BeautiCem Veneer Kit2Cleared 510(K)
- K173573Tetric CAD2Cleared 510(K)
- K173500NMF004A2Cleared 510(K)
- K173275OMNICHROMA2Cleared 510(K)
- K173643Trilor Disks, Blocks and Arches2Cleared 510(K)
- K171772Ecosite Bulk Fill2Cleared 510(K)
- K173124PEEK Biosolution2Cleared 510(K)
- K172530BEAUTIFIL Flow Plus X2Cleared 510(K)
- K172707Renamel Microfill2Cleared 510(K)
- K171815Registrado Scan2Cleared 510(K)
- K170102Pekkton Ivory2Cleared 510(K)
- K170873Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl2Cleared 510(K)
- K171200Grandio blocs2Cleared 510(K)
- K171147REVEAL Bulk2Cleared 510(K)
- K170896Admira Fusion x-base2Cleared 510(K)
- K161353ESTELITE BULK FILL Flow2Cleared 510(K)
- K162967nuance UNIVERSAL2Cleared 510(K)
- K163346MAZIC Duro2Cleared 510(K)
- K163480Renamel NANO +plus2Cleared 510(K)
- K162323Tooth Shade Resin Material2Cleared 510(K)
- K162261CERAMAGE UP2Cleared 510(K)
- K163207Filtek One Bulk Fill Restorative2Cleared 510(K)
- K162537CAD/CAMouflage Milling Block2Cleared 510(K)
- K160049Charisma2Cleared 510(K)
- K162257P1145 Dental Restorative2Cleared 510(K)
- K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow2Cleared 510(K)
- K162107TPH Spectra+ Universal Composite Restorative2Cleared 510(K)
- K153476KATANA AVENCIA Block2Cleared 510(K)
- K152471CAPO BULK FILL2Cleared 510(K)
- K153493Clip Flow2Cleared 510(K)
- K160596BEAUTIFIL II LS2Cleared 510(K)
- K160086SHOFU Enamel Conditioner2Cleared 510(K)
- K152113BioHPP - breCAM.BioHPP2Cleared 510(K)
- K160425CAD/CAMouflage Milling Bock2Cleared 510(K)
- K153325Gradia Plus2Cleared 510(K)
- K153177Admira Fusion Flow2Cleared 510(K)
- K153127everX Posterior2Cleared 510(K)
- K152927BRILLIANT EVERGLOW2Cleared 510(K)
- K153249Pulpdent Solo Flowable Composite with MCP2Cleared 510(K)
- K151700BEAUTIFIL II Gingiva2Cleared 510(K)
- K153191Calcium Bridge2Cleared 510(K)
- K152373VITA VM LC Flow2Cleared 510(K)
- K151699BEAUTIFIL II Enamel2Cleared 510(K)
- K152004Nanova Universal Composite2Cleared 510(K)
- K151956Admira Fusion x-tra2Cleared 510(K)
- K151541G-Fix2Cleared 510(K)
- K151514Prestige2Cleared 510(K)
- K151088DMRC Bulk Fill2Cleared 510(K)
- K151094Mosaic Universal Composite2Cleared 510(K)
- K150784Admira Fusion2Cleared 510(K)
- K150218Fill-Up!2Cleared 510(K)
- K150623Nanova Flowable Composite2Cleared 510(K)
- K150393TETRIC EVOFLOW BULK FILL2Cleared 510(K)
- K143524Fiber Disks and Blocks (TRINIA)2Cleared 510(K)
- K143694Rhondium One-Visit-Crown(OVC)2Cleared 510(K)
- K143679Nuance FLOW2Cleared 510(K)
- K143104Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X2Cleared 510(K)
- K143209SonicFill 22Cleared 510(K)
- K142389Variolink Esthetic2Cleared 510(K)
- K141994BULK FILL FLOWABLE COMPOSITE2Cleared 510(K)
- K140976ENADEN FLOW2Cleared 510(K)
- K140512UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE2Cleared 510(K)
- K132115ABSOLUTE DENTIN 22Cleared 510(K)
- K133850CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)2Cleared 510(K)
- K141081FILTEK BULK FILL POSTERIOR RESTROATIVE2Cleared 510(K)
- K133182HTFX-2222Cleared 510(K)
- K133824CERASMART2Cleared 510(K)
- K133608TRINIA2Cleared 510(K)
- K132748BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK2Cleared 510(K)
- K131753MERIDIAN2Cleared 510(K)
- K132141BEAUTIFIL BULK FLOWABLE2Cleared 510(K)
- K130841SHOFU BLOCK HC2Cleared 510(K)
- K130672OPTIFLOW II FLOWABLE COMPOSITE, LC2Cleared 510(K)
- K123631MFP-0512Cleared 510(K)
- K131504UNIVERSAL OPAQUE2Cleared 510(K)
- K123823INTERLIG2Cleared 510(K)
- K130371CLEARFIL MAJESTY ES FLOW2Cleared 510(K)
- K121769DENTOCORE / DENTOCORE BODY2Cleared 510(K)
- K121735FIBER DISK AND BLOCK PERMANENT, TRINIA2Cleared 510(K)
- K123397MULTILINK AUTOMIX2Cleared 510(K)
- K123304SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO2Cleared 510(K)
- K123773X-TRA BASE2Cleared 510(K)
- K120237BPA-FREE MICROHYBID COMPOSITE2Cleared 510(K)
- K121915BRIGHT RESTORATIVE MATERIALS2Cleared 510(K)
- K121880DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID2Cleared 510(K)
- K122569LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR2Cleared 510(K)
- K121230IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE2Cleared 510(K)
- K121583CLEARFIL MAJESTY FLOW2Cleared 510(K)
- K120768ES FLOW2Cleared 510(K)
- K120453FILTEK BULK FILL FLOWABLE RESTORATIVE2Cleared 510(K)
- K113617SPEE-DEE PATCH2Cleared 510(K)
- K112044ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A2Cleared 510(K)
- K113444N-HYBRIDE-COMPOSITE LC FLOW2Cleared 510(K)
- K113563N-HYBRIDE-COMPOSITE LC2Cleared 510(K)
- K112501VENUS PEARL PLT REFILL A12Cleared 510(K)
- K112168COMPONEER2Cleared 510(K)
- K111982CLEARFIL DC CORE PLUS2Cleared 510(K)
- K112447GRANDIO CORE DUAL CURE2Cleared 510(K)
- K112374X-TRA BASE2Cleared 510(K)
- K111958TETRIC EVOCERAM BULK FILL2Cleared 510(K)
- K110859METAL OPAQUER2Cleared 510(K)
- K110642SILJETR SYSTEM2Cleared 510(K)
- K110589CIMARA2Cleared 510(K)
- K110178ESTELITE COLOR2Cleared 510(K)
- K110428ESCOM 1002Cleared 510(K)
- K103528IPS EMPRESS DIRECT FLOW2Cleared 510(K)
- K103190PROFIL COMPOSITES (PROFIL, PROFIL FLOW)2Cleared 510(K)
- K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE2Cleared 510(K)
- K103580GRANDIO SO FLOW2Cleared 510(K)
- K103351DMC COMPOSITE 22Cleared 510(K)
- K102703BUILD-IT TOTAL CORE2Cleared 510(K)
- K102984AURA2Cleared 510(K)
- K102255DMP ETCHING GEL2Cleared 510(K)
- K102257NANOCERAM- BRIGHT2Cleared 510(K)
- K102603SA FLOWABLE ADHESIVE2Cleared 510(K)
- K102354GRANDIO SO HEAVY FLOW2Cleared 510(K)
- K102351GRANDIO SO2Cleared 510(K)
- K101540GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE2Cleared 510(K)
- K102526BLO2X OXYGEN BLOCKER2Cleared 510(K)
- K102450IONOLUX PRO2Cleared 510(K)
- K101621LITE ART2Cleared 510(K)
- K101603BEAUTIFIL FLOW PLUS2Cleared 510(K)
- K101213GRANDIO FLOW2Cleared 510(K)
- K101215NUANCE2Cleared 510(K)
- K100235FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE2Cleared 510(K)
- K100083ESTHETICA2Cleared 510(K)
- K100328CLEARFIL MAJETY POSTERIOR2Cleared 510(K)
- K100413TEMP IT2Cleared 510(K)
- K093470CORE-FLO D/C2Cleared 510(K)
- K093484PREMISE FLOWABLE MODIFIED2Cleared 510(K)
- K092912STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 901502Cleared 510(K)
- K092730COSMEDENT BRUSHABLE COMPOSITE2Cleared 510(K)
- K092501LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL2Cleared 510(K)
- K091512BUILD-IT LIGHT CURE2Cleared 510(K)
- K092281CLEARFIL MAJESTY POSTERIOR PLT2Cleared 510(K)
- K091091SONICFILL 20102Cleared 510(K)
- K092539SEAMFREE2Cleared 510(K)
- K091647INJECTAFIL2Cleared 510(K)
- K092572CORE*IT DUAL2Cleared 510(K)
- K091388GCUC-5052Cleared 510(K)
- K090843AMARIS GINGIVA OPAQUER2Cleared 510(K)
- K090704MULTILINK IMPLANT2Cleared 510(K)
- K090747MI FLOW (GCUC-450)2Cleared 510(K)
- K091023METAMORPHOSIS2Cleared 510(K)
- K090391PULPDENT MICRO-HYBRID COMPOSITE2Cleared 510(K)
- K090701EMPRESS DIRECT2Cleared 510(K)
- K083841ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL2Cleared 510(K)
- K090292PREMISE MODIFIED2Cleared 510(K)
- K083326FLUOROCORE 22Cleared 510(K)
- K083610FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE2Cleared 510(K)
- K082671HERCULITE ULTRA2Cleared 510(K)
- K082434GDLS-2002Cleared 510(K)
- K082171GRADIA CORE2Cleared 510(K)
- K081695DMC COMPOSITE2Cleared 510(K)
- K073047APROXI 1100 AND 4000 SERIES DENTAL INLAYS2Cleared 510(K)
- K080940ESTELITE SIGMA QUICK2Cleared 510(K)
- K080478GRADIA FORTE2Cleared 510(K)
- K080480NANOCOMPOSITE RESTORATIVE KIT2Cleared 510(K)
- K080305NEXCOMP AND META ETCHANT2Cleared 510(K)
- K080068BEAUTIFIL OPAQUER2Cleared 510(K)
- K0727333M ESPE ADULT CROWN2Cleared 510(K)
- K080265DENFIL ETCHANT-372Cleared 510(K)
- K073554NEUN2Cleared 510(K)
- K072746E-1 ESTHETIC COMPOSITE SYSTEM2Cleared 510(K)
- K072545ARTISTE SE FLOWABLE COMPOSITE, MODEL N2802Cleared 510(K)
- K072069SPACER2Cleared 510(K)
- K072150DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL2Cleared 510(K)
- K071742BEAUTIFIL II2Cleared 510(K)
- K071288MODIFICATION TO KAVO QUATTROCARE2Cleared 510(K)
- K071278EMBRACE DUAL CURE COMPOSITE MATERIALS2Cleared 510(K)
- K071169CLEARFIL MAJESTY POSTERIOR PLT2Cleared 510(K)
- K071386AMARIS/AMARIS FLOW2Cleared 510(K)
- K070702FUSION RESIN CEMENT AND CORE KIT2Cleared 510(K)
- K070693AURAVUE PIT & FISSURE SEALANT2Cleared 510(K)
- K070583NANO COMPOSITE2Cleared 510(K)
- K070325CLEARFIL MAJESTY ESTHETIC PLT2Cleared 510(K)
- K070190GRADIA DIRECT X2Cleared 510(K)
- K070191ALPHA-CORE DC2Cleared 510(K)
- K063595CLEARFIL MAJESTY POSTERIOR2Cleared 510(K)
- K063593CLEARFIL MAJESTY FLOW2Cleared 510(K)
- K063714AXCEL FLOW2Cleared 510(K)
- K063604TWINKY STAR NF2Cleared 510(K)
- K062345CERAMIC BOND2Cleared 510(K)
- K062518CELERITY2Cleared 510(K)
- K062515RETENTION FLOW OPAQUE2Cleared 510(K)
- K062906ENA HFO COMPOSITE SYSTEM2Cleared 510(K)
- K062409K-ETCHANT GEL2Cleared 510(K)
- K062343GRANDIO FLOW TRY-IN2Cleared 510(K)
- K062157CONFORM2Cleared 510(K)
- K061906CLEARFIL CERAMIC PRIMER2Cleared 510(K)
- K061860CLEARFIL MAJESTY ESTHETIC2Cleared 510(K)
- K061664FORMCORE DC, MODEL 28-7001002Cleared 510(K)
- K060893MODIFICATION TO REBILDA DC2Cleared 510(K)
- K060472PREMISE FLOWABLE2Cleared 510(K)
- K060637DENFIL FLOW2Cleared 510(K)
- K051931AXCEL2Cleared 510(K)
- K053391X-TRA FIL2Cleared 510(K)
- K052820PARAPOST PARACORE AUTOMIX 5ML2Cleared 510(K)
- K052779BRECOMP2Cleared 510(K)
- K052106SIMILE FLOW2Cleared 510(K)
- K052097CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE2Cleared 510(K)
- K051808ESTELITE FLOW QUICK2Cleared 510(K)
- K051818BEAUTIFIL FLOW2Cleared 510(K)
- K051867GRANDIO2Cleared 510(K)
- K051868GRANDIO FLOW2Cleared 510(K)
- K050401CERAMAGE2Cleared 510(K)
- K050880DYRACT EXTRA RESTORATIVE2Cleared 510(K)
- K042804TESCERA OPAQUER POWDER/SCULPTING RESIN2Cleared 510(K)
- K043177CLEAFIL DC CORE AUTOMIX2Cleared 510(K)
- K043119AMELOGEN PLUS2Cleared 510(K)
- K042929ESTENIA C&B2Cleared 510(K)
- K042348GRADIA DIRECT LOFLO2Cleared 510(K)
- K042819TETRIC EVOCERAM2Cleared 510(K)
- K042124DENFIL2Cleared 510(K)
- K040465LATIT FLOW2Cleared 510(K)
- K040994COSMEDENT CORE PASTE2Cleared 510(K)
- K040795MULTICORE HB; MULTICORE FLOW2Cleared 510(K)
- K040144QUIXX POSTERIOR RESTORATIVE2Cleared 510(K)
- K033970CLEARFIL PHOTO CORE PLT2Cleared 510(K)
- K033996HERMES2Cleared 510(K)
- K033808GRADIA GUM2Cleared 510(K)
- K033773CONCEPT HP ADD-ON; CONCEPT HP ENAMEL2Cleared 510(K)
- K033665VENUS FLOW2Cleared 510(K)
- K033267EPRICORD2Cleared 510(K)
- K033117GRANDIO FLOW2Cleared 510(K)
- K032921PREMISE2Cleared 510(K)
- K031341STICK FLOW2Cleared 510(K)
- K031721COMPOSITE RESTORATION MATERIAL2Cleared 510(K)
- K031877EMBRACE WET-BOND RESTORATIVE MATERIAL2Cleared 510(K)
- K030951TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P2Cleared 510(K)
- K030915GRANDIO2Cleared 510(K)
- K030914REBILDA DC2Cleared 510(K)
- K030133SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE2Cleared 510(K)
- K0240944 SEASONS2Cleared 510(K)
- K023814GRADIA DIRECT2Cleared 510(K)
- K023742SCULPTURE PLUS NANO-HYBRID COMPOSITE2Cleared 510(K)
- K022971MICROHYBRID 112Cleared 510(K)
- K022974MICROHYBRID 122Cleared 510(K)
- K022972MICROFILL 132Cleared 510(K)
- K022975ETCHING 152Cleared 510(K)
- K022675PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL2Cleared 510(K)
- K023002CLEARFIL AP-X PLT2Cleared 510(K)
- K022999CLEARFIL AP-X PLT INTRO KIT2Cleared 510(K)
- K021250MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)2Cleared 510(K)
- K022492PULPDENT SEMI-GEL ETCH2Cleared 510(K)
- K022797TWINKY STAR2Cleared 510(K)
- K020113VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES2Cleared 510(K)
- K020760STARFLOW HV2Cleared 510(K)
- K020555SONATA MICRO HYBRID COMPOSITE2Cleared 510(K)
- K020432PULPDENT GLAZE2Cleared 510(K)
- K020342UNIFIL FLOW2Cleared 510(K)
- K014111REBILDA SC2Cleared 510(K)
- K020131VENUS UNIVERSAL LIGHT CURING COMPOSITE2Cleared 510(K)
- K013970PRIME-DENT HEMA DESENSITIZER2Cleared 510(K)
- K014144EXTORAL/TESCERA GLAZING RESIN, MODEL T-18042Cleared 510(K)
- K013929HELIOMOLAR HB TRANSLUCENT SHADES2Cleared 510(K)
- K013510POINT 4 MODIFIED2Cleared 510(K)
- K013571MAGICFIL2Cleared 510(K)
- K011839DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C2Cleared 510(K)
- K013647REVOLUTION FORMULA 22Cleared 510(K)
- K013529POINT 4 TRANSLUCENT MODIFIED2Cleared 510(K)
- K013400SYNERGY FLOW2Cleared 510(K)
- K012794PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT2Cleared 510(K)
- K013375BELLEGLASS HP OPAQUE 22Cleared 510(K)
- K013325POINT 4 FLOWABLE 22Cleared 510(K)
- K012529ROK2Cleared 510(K)
- K012528ICE2Cleared 510(K)
- K013009BELLEGLASS HP DC OPACEOUS DENTIN LCTE 22Cleared 510(K)
- K013007BELLEGLASS HP ENAMEL 22Cleared 510(K)
- K012160COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 30014082Cleared 510(K)
- K012740CLEARFIL AP-X2Cleared 510(K)
- K012737CHROMA ZONE COLOR STAIN2Cleared 510(K)
- K010849VERTEX ETCHANT2Cleared 510(K)
- K012707ESTENIA2Cleared 510(K)
- K012705CLEARFIL PHOTO CORE2Cleared 510(K)
- K012704CLEARFIL ST OPAQUER2Cleared 510(K)
- K012703CLEARFIL CORE NEW BOND2Cleared 510(K)
- K012180A-WEAR2Cleared 510(K)
- K012321POINT 4 FLOWABLE2Cleared 510(K)
- K012307LUXACORE/LUXACORE DUAL2Cleared 510(K)
- K011798CORERESTORE 22Cleared 510(K)
- K011453TOOTH SHADE RESIN MATERIAL2Cleared 510(K)
- K011756ADMIRA FLOW2Cleared 510(K)
- K011517LUTE; CORE2Cleared 510(K)
- K011492IN TEN-S2Cleared 510(K)
- K011295RESTORE-PF VIC; RESTORE-PF VLC CAPSULE2Cleared 510(K)
- K011309LUTE VLC; CORE VLC2Cleared 510(K)
- K011211FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW2Cleared 510(K)
- K010475D/C CORE MATERIAL2Cleared 510(K)
- K010914BEAUTIFIL2Cleared 510(K)
- K0107813M ESPE HAUR2Cleared 510(K)
- K010196TOTAL CURE2Cleared 510(K)
- K010250TETRIC CERAM HB2Cleared 510(K)
- K010267PALFIQUE ESTELITE LV CLEAR2Cleared 510(K)
- K010219CHALLENGER DIRECT COMPOSITE2Cleared 510(K)
- K002863PALFIQUE ESTELITE LV2Cleared 510(K)
- K003034COLTENE AURA COMPOMER RESTORATIVE SYSTEM2Cleared 510(K)
- K003361RENEW LS-22Cleared 510(K)
- K003317RENEW LS-12Cleared 510(K)
- K001899IMPROVED TRY-IN GEL2Cleared 510(K)
- K002086PRIMAFLOW2Cleared 510(K)
- K001799DC-TELL2Cleared 510(K)
- K001913CLEARFIL ST OPAQUER2Cleared 510(K)
- K001623SCULPTURE FLOW2Cleared 510(K)
- K001518GRADIA2Cleared 510(K)
- K001360SIGNUM2Cleared 510(K)
- K001108PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL2Cleared 510(K)
- K000530BELLEGLASS HP ENAMEL2Cleared 510(K)
- K000357EZ CONNECT RESIN2Cleared 510(K)
- K000436BELLEGLASS HP TRANSLUCENT DENTIN2Cleared 510(K)
- K000269BELLEGLASS HP OPACEOUS DENTIN2Cleared 510(K)
- K000211BUILD-IT FR2Cleared 510(K)
- K993514DEFINITE2Cleared 510(K)
- K994304ARABESK FLOW2Cleared 510(K)
- K994268ARABESK TOP2Cleared 510(K)
- K994224PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL2Cleared 510(K)
- K993658RENAMEL SCULPT2Cleared 510(K)
- K993659RENAMEL PACK2Cleared 510(K)
- K994056ADMIRA2Cleared 510(K)
- K993973FUJI II LC CAPSULE2Cleared 510(K)
- K994251KETAC-MOLAR QUICK2Cleared 510(K)
- K993932SOLITAIRE 22Cleared 510(K)
- K993716PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE2Cleared 510(K)
- K993602PRE-VISION FILL2Cleared 510(K)
- K993783TETRIC FLOW2Cleared 510(K)
- K993566PROMPTFLOW2Cleared 510(K)
- K992909HYTAC2Cleared 510(K)
- K993488LIGHT-CORE2Cleared 510(K)
- K993192ILLUSION2Cleared 510(K)
- K992966REFERENCE2Cleared 510(K)
- K992645SINFONY2Cleared 510(K)
- K992102LUMA LIGHT 2000 CURE LIGHT2Cleared 510(K)
- K992248POST CEMENT HI-X2Cleared 510(K)
- K992118PRODIGY 4 TRANSLUCENT SHADES2Cleared 510(K)
- K9919613M LVR SYSTEM2Cleared 510(K)
- K991450ETCHING GEL2Cleared 510(K)
- K991491FLC COMPOSITE2Cleared 510(K)
- K991488SELF CURE COMPOSITE2Cleared 510(K)
- K991442LC MICROFILL2Cleared 510(K)
- K990756FLOW LINE2Cleared 510(K)
- K990982CAVIT LC2Cleared 510(K)
- K990898PRODIGY 42Cleared 510(K)
- K990314MULTI-CURE COMPOSITE CEMENT2Cleared 510(K)
- K990108LC FLOWFILL2Cleared 510(K)
- K990315MONOPAQUE2Cleared 510(K)
- K984097DC-CORE2Cleared 510(K)
- K984484LC MICROHYBRID2Cleared 510(K)
- K984387R-30 AESTHETIC RESTORATIVE2Cleared 510(K)
- K984112ADVENT2Cleared 510(K)
- K984044QUADRANT POSTERIOR DENSE2Cleared 510(K)
- K984043QUADRANT TOTAL ETCH2Cleared 510(K)
- K984042QUADRANT CORE LC2Cleared 510(K)
- K984041QUADRANT UNIVERSAL LC2Cleared 510(K)
- K983751QUADRANT UNICHEM2Cleared 510(K)
- K983549QUADRANT ANTERIOR SHINE2Cleared 510(K)
- K983370PRODIGY- 32Cleared 510(K)
- K980800LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL2Cleared 510(K)
- K983091ELAN-22Cleared 510(K)
- K982692STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC2Cleared 510(K)
- K982259CHROMA ZONE COLOR STAIN2Cleared 510(K)
- K982729RENEW2Cleared 510(K)
- K982318SPECTRUM 800 CURING UNIT2Cleared 510(K)
- K982191CHEMICAL CURE COMPOSITE WITH ENAMEL BOND2Cleared 510(K)
- K982645PYRAMID2Cleared 510(K)
- K982395DYTRACT FLOW RESTORATIVE2Cleared 510(K)
- K981948APOLLO 95E2Cleared 510(K)
- K982201ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)2Cleared 510(K)
- K982164ESTENIA2Cleared 510(K)
- K9816473M DENT II SYSTEM2Cleared 510(K)
- K982148PRODIGY 22Cleared 510(K)
- K981562SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT2Cleared 510(K)
- K981813PERMACEM AUTOMIX LUTING CEMENT SYSTEM2Cleared 510(K)
- K981264ARISTON PHC2Cleared 510(K)
- K980018CRISTOBAL2Cleared 510(K)
- K980793Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT2Cleared 510(K)
- K980792CU-100A LIGHT CURE UNIT2Cleared 510(K)
- K980058TOKUSO MAC BOND II2Cleared 510(K)
- K980054PALFIQUE ESTELITE2Cleared 510(K)
- K974465SYNERGY2Cleared 510(K)
- K980051PALFIQUE ESTELITE PASTE2Cleared 510(K)
- K974483NTL-FLOW2Cleared 510(K)
- K973221COMPOSITE 168 RESTORATIVE SYSTEM2Cleared 510(K)
- K973235DYRACT AP RESTORATIVE2Cleared 510(K)
- K974413PERMAFLO2Cleared 510(K)
- K974577COMPOGLASS FLOW2Cleared 510(K)
- K974282VITALESCENCE2Cleared 510(K)
- K974105KERR COMPOMER2Cleared 510(K)
- K973513SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER2Cleared 510(K)
- K974131ALERT2Cleared 510(K)
- K973091WAVE2Cleared 510(K)
- K973089FREEDOM2Cleared 510(K)
- K973976EPIC-FLO2Cleared 510(K)
- K973257VERSAETCH2Cleared 510(K)
- K972292SOLIDEX2Cleared 510(K)
- K972892CAVIT-LC2Cleared 510(K)
- K971762BELLEGLASS HP ENAMEL REPAIR MATERIAL2Cleared 510(K)
- K971594FLOW-RITE2Cleared 510(K)
- K970683ZENTIH FLOWABLE COMPOSITE (MULTIPLE)2Cleared 510(K)
- K971898PERMALUTE, TRY-IN PASTE2Cleared 510(K)
- K971513COMPOGLASS F2Cleared 510(K)
- K971372VARIOLINK II2Cleared 510(K)
- K9705003M SUSTEL DENTAL SYSTEM2Cleared 510(K)
- K970495FOUNDATION INDIRECT COMPOSITE RESIN2Cleared 510(K)
- K970246EDTA CAVIT2Cleared 510(K)
- K962376KREATIV KURING LIGHT SYSTEM2Cleared 510(K)
- K964931WHITE CORE2Cleared 510(K)
- K965060ULTRA-ETCH STAT2Cleared 510(K)
- K964285TETRIC CERAM2Cleared 510(K)
- K964179SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS2Cleared 510(K)
- K964578FIBREKOR2Cleared 510(K)
- K963805PRODIGY AC2Cleared 510(K)
- K963735COJET SYSTEM2Cleared 510(K)
- K963652PULPDENT DESENSITIZER2Cleared 510(K)
- K963311TEAM ETCH2Cleared 510(K)
- K962909DENTAL PREP WASH AND PREP DISINFECT2Cleared 510(K)
- K962878TARGIS SYSTEM2Cleared 510(K)
- K962442HYTAC APLITIP/HYTAC OSB2Cleared 510(K)
- K962440PERTAC II/PERTAC II APLITIP2Cleared 510(K)
- K962192SUNRISE CURING LAMP2Cleared 510(K)
- K962405SANICURE DISPOSABLE CURING PROBE2Cleared 510(K)
- K961434VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM2Cleared 510(K)
- K960667CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE2Cleared 510(K)
- K961284KOLOR +2Cleared 510(K)
- K960729ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)2Cleared 510(K)
- K960594LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS2Cleared 510(K)
- K960600LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS2Cleared 510(K)
- K960599SUPERIOR PHOTOCURING HYBRID COMPOSITE2Cleared 510(K)
- K960598CONCORD MARYLAND BRIDGE CEMENT2Cleared 510(K)
- K960597ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE2Cleared 510(K)
- K960596ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE2Cleared 510(K)
- K960595FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS2Cleared 510(K)
- K960565ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE2Cleared 510(K)
- K960165ALPHA-DENT COMPOSITE SURFACE SEALANT2Cleared 510(K)
- K954988CRYSTALLESSENCE2Cleared 510(K)
- K955337OPAKER2Cleared 510(K)
- K955292AELITEFLO2Cleared 510(K)
- K954929CHARISMA SINGLE DOSE2Cleared 510(K)
- K954407AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE2Cleared 510(K)
- K954405AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE2Cleared 510(K)
- K954408AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE2Cleared 510(K)
- K954406AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE2Cleared 510(K)
- K954461AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE2Cleared 510(K)
- K954115ARTGLASS & KEVLOC2Cleared 510(K)
- K953525ULTRADENT FLOWABLE COMPOSITE2Cleared 510(K)
- K952662COMP=FLOW2Cleared 510(K)
- K952353EZ-COMP2Cleared 510(K)
- K952333PLASMA ARC CURING SYSTEM2Cleared 510(K)
- K952500COMPSEAL2Cleared 510(K)
- K951836COMPOLGLASS COMPOGLASS SCA2Cleared 510(K)
- K951427AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL2Cleared 510(K)
- K951426AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL2Cleared 510(K)
- K950991DYRACT II RESTORATIVE2Cleared 510(K)
- K950859PERMASEAL2Cleared 510(K)
- K950765COMPA LAB-R2Cleared 510(K)
- K942993THERMORESIN LC II2Cleared 510(K)
- K946307CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE2Cleared 510(K)
- K945539OPTIGUARD2Cleared 510(K)
- K945769TOTAL ETCH GEL2Cleared 510(K)
- K945364DYRACT(TM) MATERIAL2Cleared 510(K)
- K945173PULPDENT HARDSHELL2Cleared 510(K)
- K945113PULPDENT CERVICAL RESTORATIVE2Cleared 510(K)
- K945057PULPDENT HYBRID ANTERIOR COMPOSITE2Cleared 510(K)
- K945056PULPDENT RESIN CEMENT2Cleared 510(K)
- K945058PULPDENT MICROFILLED ANTERIOR COMPOSITE2Cleared 510(K)
- K945018PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL2Cleared 510(K)
- K944659PRODIGY2Cleared 510(K)
- K943642HERCULITE XR & XRV2Cleared 510(K)
- K943169CLEARFIL AP-X AND LINER BOND 22Cleared 510(K)
- K943168CLEARFIL AP-X2Cleared 510(K)
- K942767ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN2Cleared 510(K)
- K941899SDI COMPOSTIES2Cleared 510(K)
- K942031CAULK TOOTH CONDITIONER GEL AND SYRINGE2Cleared 510(K)
- K940737EDTA GEL (TM)2Cleared 510(K)
- K941377CONQUEST SMOOTH TOUCH2Cleared 510(K)
- K941373PENT CORE PLUS (PASTE-PASTE)2Cleared 510(K)
- K941375CONQUEST GINGA-BLEND2Cleared 510(K)
- K941374CONQUEST PRELUDE2Cleared 510(K)
- K941378PROCOM2Cleared 510(K)
- K941376CONQUEST SENIOR2Cleared 510(K)
- K940800DENTACOLOR VITA (VS) SHADE SYSTEM2Cleared 510(K)
- K930584MAGNACORE2Cleared 510(K)
- K930583MEGABOND SYSTEM2Cleared 510(K)
- K932828CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE2Cleared 510(K)
- K932829CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST2Cleared 510(K)
- K932826CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO2Cleared 510(K)
- K935736CHARISMA SUPERLIGHT2Cleared 510(K)
- K933766HIGH-Q-BOND2Cleared 510(K)
- K922251TI-CORE-NATURAL2Cleared 510(K)
- K922252TI-CORE NEW & IMPROVED2Cleared 510(K)
- K935032ZENITH TOTAL ETCH 10% PHOSPHORIC ACID2Cleared 510(K)
- K934247BISCO UNIVERSAL HYBRID COMPOSITE2Cleared 510(K)
- K934611STO2P2Cleared 510(K)
- K933656JEDENTAL PSROFILL SELF-CURE COMPOSITE2Cleared 510(K)
- K930128SR SPECTRASIT, SR CHROMASIT2Cleared 510(K)
- K932886ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE2Cleared 510(K)
- K932827ALPHA-DENT CORE BUILDUP PASTE2Cleared 510(K)
- K932154CONQUEST CRYSTAL2Cleared 510(K)
- K932793PULPDENT 2.5% NITRIC ACID ETCHANT2Cleared 510(K)
- K932227AMELOGEN RESTORATIVE MATERIALS2Cleared 510(K)
- K932792PULPDENT MALEIC ACID ETCHANTS2Cleared 510(K)
- K931867ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE2Cleared 510(K)
- K932395VLC DR MATERIAL2Cleared 510(K)
- K930405BISCO D/C CORE COMPOSITE2Cleared 510(K)
- K931309VARIOLINK2Cleared 510(K)
- K932013CHARISMA -- MODIFIED2Cleared 510(K)
- K931880PROFILL LC COMPOSITE2Cleared 510(K)
- K924727100 LIGHT CURE UNIT2Cleared 510(K)
- K920533DENTIN BONDING AGENT2Cleared 510(K)
- K926556VIVALUX2Cleared 510(K)
- K926418CLIP2Cleared 510(K)
- K926074PULPDENT DENTAL BOND ENCHANCER2Cleared 510(K)
- K925162MICRODOSE DENTIN CONDITIONER2Cleared 510(K)
- K924826MICRODOSE TOTAL ETCHANT2Cleared 510(K)
- K924822MICRODOSE ENAMEL ETCHANT2Cleared 510(K)
- K925383PHOTO CLEARFIL OPAQUER2Cleared 510(K)
- K924151BISCO D/C RESINOMER2Cleared 510(K)
- K923472COMPACOLOR2Cleared 510(K)
- K923867METAFIL2Cleared 510(K)
- K923236TRIAD INLAY COMPOSITE2Cleared 510(K)
- K921602ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT2Cleared 510(K)
- K921598ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE2Cleared 510(K)
- K921409ENAMEL AND PORCELAIN ETCH PRODUCT LINE2Cleared 510(K)
- K921407COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE2Cleared 510(K)
- K921174COMPOSITE RESIN CORE PASTE MATERIAL2Cleared 510(K)
- K920893LITE FILL II P2Cleared 510(K)
- K920892LITE FIL II A2Cleared 510(K)
- K922755PULPDENT HARD CORE2Cleared 510(K)
- K922569TETRIC LIGHT-CURING COMPOSITE2Cleared 510(K)
- K921820RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION2Cleared 510(K)
- K921439BISCO CORE PASTE2Cleared 510(K)
- K920485PUPLDENT ETCH N PREP2Cleared 510(K)
- K92048310% PHOSPHORIC ACID ETCHING GEL2Cleared 510(K)
- K92048214% HYDROFLUORIC ACID ETCHING GEL2Cleared 510(K)
- K9204842.5% NITRIC ACID ETCHING GEL2Cleared 510(K)
- K915668BISCO CAVITY CLEANSER2Cleared 510(K)
- K913089WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS2Cleared 510(K)
- K9204253M BRAND RESTORATIVE Z1002Cleared 510(K)
- K920365TOOTH BONDING AGENT2Cleared 510(K)
- K914456DENTACOLOR(R) CRE-ACTIVE2Cleared 510(K)
- K915336TWINLOOK2Cleared 510(K)
- K913200GTI CLASP COVER2Cleared 510(K)
- K915355ADS-GEL AND INSULATING-GEL2Cleared 510(K)
- K915335SILICOATER SYSTEM2Cleared 510(K)
- K913966SONO(R) -CEM2Cleared 510(K)
- K913947IMPERVA BOND2Cleared 510(K)
- K913100PALFIQUE INLAY2Cleared 510(K)
- K913099PALFIQUE LITEPOSTERIOR2Cleared 510(K)
- K912788CURAY SUPPORT2Cleared 510(K)
- K912708CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM2Cleared 510(K)
- K912037DEGULUX LIGHT CURING UNIT2Cleared 510(K)
- K910263CHARISMA2Cleared 510(K)
- K904813VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.2Cleared 510(K)
- K911524PALFIQUE ESTELITE2Cleared 510(K)
- K910627ALPHA-FIL, ALPHA-BASE & ALPHA-SILVER, MODIFICATION2Cleared 510(K)
- K905604VISIO-GEM ART-SYSTEM2Cleared 510(K)
- K904805TENTATIVE OPERATING NAME-JAZZ BAND2Cleared 510(K)
- K905131DURAFILL COLOR VS2Cleared 510(K)
- K904812COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE2Cleared 510(K)
- K905476STOMADENT TM2Cleared 510(K)
- K905221SPECIAL BOND II2Cleared 510(K)
- K905220MONOBOND S2Cleared 510(K)
- K903481ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER2Cleared 510(K)
- K904555DURAFILL FLOW2Cleared 510(K)
- K901260CORADENT2Cleared 510(K)
- K903587HELIOLINK TRY-IN PASTES2Cleared 510(K)
- K902040ALTIS (RESIN, CROWN AND BRIDGES)2Cleared 510(K)
- K903551TEMPOREX2Cleared 510(K)
- K902893TI-CORE (DENTAL COMPOSITE)2Cleared 510(K)
- K902402HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE2Cleared 510(K)
- K901868DEGUFILL (R) M2Cleared 510(K)
- K901869DEGUFILL (R) H2Cleared 510(K)
- K902745DEGUFILL (TM)2Cleared 510(K)
- K900510PERTAC-HYBRID2Cleared 510(K)
- K902743DEGUFILL (TM) ETCHANT GEL2Cleared 510(K)
- K901872DEGUFILL (R) ETCHANT2Cleared 510(K)
- K901917DUAL CEMENT2Cleared 510(K)
- K901914HELIO PROGRESS (DENTAL COMPOSITE)2Cleared 510(K)
- K901910HELIO LINK (RESIN CEMENT)2Cleared 510(K)
- K901918HELIOTINT2Cleared 510(K)
- K901916SPECIAL BOND2Cleared 510(K)
- K901697SILISTOR CERAMIC AND RESIN REPAIR SYSTEM2Cleared 510(K)
- K896469EOS INLAY MATERIAL2Cleared 510(K)
- K901396CONCEPT INLAY/ONLAY2Cleared 510(K)
- K897011PALFIQUE LIGHT-S COMPOSITE RESIN2Cleared 510(K)
- K897010PALFIQUE LIGHT COMPOSITE RESIN2Cleared 510(K)
- K896769INTERFACE BONDING SYSTEM2Cleared 510(K)
- K896530FERMIT TEMPORARY MATERIAL2Cleared 510(K)
- K90105122% POLYACRYLIC ACID GEL2Cleared 510(K)
- K900690CLEARFIL VENEER BOND KIT2Cleared 510(K)
- K896950CORE BUILD UP COMPOSITE2Cleared 510(K)
- K896662AIR BLOCK2Cleared 510(K)
- K896658DENTIN DISCLOSING GEL AND GEL REMOVER2Cleared 510(K)
- K896654DRYING AGENT2Cleared 510(K)
- K896653SEPARATING MEDIUM (POLYVINYL ALCOHOL)2Cleared 510(K)
- K896564DENTAL CORE MATERIAL2Cleared 510(K)
- K896132ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)2Cleared 510(K)
- K895976TOOTH SHADE RESIN2Cleared 510(K)
- K895401NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM2Cleared 510(K)
- K894890CRYSTALLINE C2 AND CRYSTALLINE L32Cleared 510(K)
- K894644CROWN AND BRIDGE DENTAL RESTORATIVE COMPOSITE SYST2Cleared 510(K)
- K892455KULZER ADHESIVE CEMENT2Cleared 510(K)
- K892454KULZER INLAY SYSTEM2Cleared 510(K)
- K891698ZAROLAN, DUALAN, TITAN AND SUPERON2Cleared 510(K)
- K891020ESPE TULUX-CEM2Cleared 510(K)
- K891463ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM2Cleared 510(K)
- K890123CLEARFIL CR INLAY2Cleared 510(K)
- K890140PHOSPHORIC-ACID ETCHING GEL2Cleared 510(K)
- K884588HELIOMOLAR(R) DENTAL RESTORATIVE2Cleared 510(K)
- K884681UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT2Cleared 510(K)
- K884391PREMET, METAL PRIMER2Cleared 510(K)
- K884350UNIREST COMPOSITE RESTORATIVE, SELF CURED2Cleared 510(K)
- K884351UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID2Cleared 510(K)
- K884352SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED2Cleared 510(K)
- K884038FIBERLITE, FIBERLITE HS AND FIBERSEAL2Cleared 510(K)
- K882566VISIO-PERL2Cleared 510(K)
- K883392LUMINBOND, BONDING AND CEMENTATION SYSTEM2Cleared 510(K)
- K882915FORTIFY2Cleared 510(K)
- K882576ACID ETCH GEL2Cleared 510(K)
- K882400AMORPHUS SILK BY DENTRAX2Cleared 510(K)
- K881903PROSTHODENT VL2Cleared 510(K)
- K882006CLEARFIL PHOTO CORE2Cleared 510(K)
- K880765G-CERA PORCELAIN BOND2Cleared 510(K)
- K875313PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST2Cleared 510(K)
- K872588CLEARFIL PHOTO POSTERIOR2Cleared 510(K)
- K875256BISCOLOR2Cleared 510(K)
- K874189DUAL-CURE RADIOPAQUE2Cleared 510(K)
- K873123LEE COMPOSITE INLAY SYSTEM2Cleared 510(K)
- K874275OPTEC SUPPLEMENTARY KIT2Cleared 510(K)
- K874162OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT2Cleared 510(K)
- K873683CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)2Cleared 510(K)
- K873886CLEARFIL PORCELAIN REPAIR SYSTEM2Cleared 510(K)
- K873878#24L SYSTEM2Cleared 510(K)
- K872444SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL2Cleared 510(K)
- K872510DEN-MAT TENURE2Cleared 510(K)
- K872960CLEARFIL POSTERIOR NEW BOND2Cleared 510(K)
- K872907DENTIN ADHESIVE2Cleared 510(K)
- K872890SYNERGY2Cleared 510(K)
- K872569TEMREX ETCHING GEL2Cleared 510(K)
- K871898IMPERVA-P2Cleared 510(K)
- K871899IMPERVA-A2Cleared 510(K)
- K871634CLEARFIL FII NEW BOND2Cleared 510(K)
- K871637CLEARFIL CORE NEW BOND2Cleared 510(K)
- K871635CLEARFIL POSTERIOR 32Cleared 510(K)
- K872243PEKALUX(TM)2Cleared 510(K)
- K872279SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER2Cleared 510(K)
- K872272PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS2Cleared 510(K)
- K871164GLUMA(TM) BONDING SYSTEM2Cleared 510(K)
- K871295ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM2Cleared 510(K)
- K871270PERFORM DENTURE BASE RESIN2Cleared 510(K)
- K871165LUMIFOR(TM) COMPOSITE2Cleared 510(K)
- K870628MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM2Cleared 510(K)
- K870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM2Cleared 510(K)
- K865028ESPE CHELON-SILVER2Cleared 510(K)
- K864710ISOSIT N2Cleared 510(K)
- K864346REMBRANDT PORCELAIN TINTING KIT2Cleared 510(K)
- K863876OMNI-FIL2Cleared 510(K)
- K863882OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE2Cleared 510(K)
- K863401RECOVER2Cleared 510(K)
- K863552IMPROVED COMSPAN2Cleared 510(K)
- K862546MICROFILL PONTIC2Cleared 510(K)
- K863174CAULK'S POLISHING PASTE2Cleared 510(K)
- K863157RESTODENT POSTERIOR2Cleared 510(K)
- K863314ESTILUX(R) POSTERIOR C2Cleared 510(K)
- K863315MULTIFIL(R) VS2Cleared 510(K)
- K863031TWIN-CORE2Cleared 510(K)
- K863092DENTAL COMPOSITE RESTORATIVE2Cleared 510(K)
- K862942PHOTO CLEARFIL BRIGHT2Cleared 510(K)
- K862292ESPE VISIO-MOLAR2Cleared 510(K)
- K862232PANAVIA TC, AND PANAVIA OPAQUE2Cleared 510(K)
- K862449DEN-MAT DENTIN LINK2Cleared 510(K)
- K862648V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT2Cleared 510(K)
- K861833RESTOR (COMET)*DENTAL RESTORATIVE2Cleared 510(K)
- K861899SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE2Cleared 510(K)
- K860487URENAMEL, POSTERIOR RESTORATIVE MATERIAL2Cleared 510(K)
- K861740P-50 LIGHT CURED RESIN BONDED CERAMIC2Cleared 510(K)
- K861546REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT2Cleared 510(K)
- K861148BISCO'S PORCELAIN VENEER SYSTEM2Cleared 510(K)
- K860708PHOTO CLEARFIL OPAQUER2Cleared 510(K)
- K860626NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID2Cleared 510(K)
- K860627SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE2Cleared 510(K)
- K854755RENAMEL ESTHETIC RESTORATIVE SYSTEM2Cleared 510(K)
- K854803CHAMELEON BONDING KIT2Cleared 510(K)
- K853055LIGHT CURE FILLING MATERIAL2Cleared 510(K)
- K853431DENTAL CEMENT2Cleared 510(K)
- K852868WUNDERSHADE2Cleared 510(K)
- K853001BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)2Cleared 510(K)
- K853002BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR)2Cleared 510(K)
- K852744CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR2Cleared 510(K)
- K852745PORCELAIN VENEER SYSTEM BONDING KIT2Cleared 510(K)
- K851929RESTORE*2Cleared 510(K)
- K852659BIOGLOSS2Cleared 510(K)
- K852658ETEN-GEL2Cleared 510(K)
- K852344DISTALITE POSTERIA DENTAL RESTORATIVE2Cleared 510(K)
- K852151PHOTO CURING LIGHT2Cleared 510(K)
- K851459VISILUX 2 VISIBLE LIGHT CURING UNIT2Cleared 510(K)
- K850965KULZER DENTIN ADHESIVE2Cleared 510(K)
- K850911TRIAD C & B MATERIAL2Cleared 510(K)
- K850824PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST2Cleared 510(K)
- K844662KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI2Cleared 510(K)
- K845033FOREMOST DENTIN ADHESIVE2Cleared 510(K)
- K844326OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE2Cleared 510(K)
- K843363RESTODENT VL2Cleared 510(K)
- K843026KERR GELLED PHOSPHORIC ACID ETCHANT2Cleared 510(K)
- K843072EVER-BOND V GLASS LONOMER RESTORATIVE2Cleared 510(K)
- K842087BISFIL-I LIGHT CURABLE POSTERIOR COMPO2Cleared 510(K)
- K841550SCOTCHBOND LIGHT CURED DENTAL ADHES2Cleared 510(K)
- K841667WUNDERFIL2Cleared 510(K)
- K841269C-192Cleared 510(K)
- K841268C-172Cleared 510(K)
- K841518JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)2Cleared 510(K)
- K841267C-182Cleared 510(K)
- K833797LIGHT CURED RESIN BONDED CERAMIC2Cleared 510(K)
- K840727PENTRA-FIL II2Cleared 510(K)
- K840176ESTIC MICROFILL2Cleared 510(K)
- K841111REMBRANDT SHADE MODIFICATION KIT2Cleared 510(K)
- K840084COLTENE BRILLIANT LUX2Cleared 510(K)
- K833725PRE-LOADED C-R TUBES FOR SYRINGE2Cleared 510(K)
- K840085COLTENE BRILLIANT2Cleared 510(K)
- K833810CURAY-MATCH PAINT-ON COMPOSITE RESTOR2Cleared 510(K)
- K834247MATERIAL TOOTHSADE RESIN2Cleared 510(K)
- K834046LUXENE VINYL-JECT 3600-802Cleared 510(K)
- K833757VISIO-GEM2Cleared 510(K)
- K831351PERMALUX VISIBLE CURE COMPOSITE RESTOR2Cleared 510(K)
- K832781CURAY-SUPPORT, CORE BUILD-UP MATERIAL2Cleared 510(K)
- K831215DENTACOLOR LIGHT CURING CROWN & BRIDGE2Cleared 510(K)
- K832062ADAPTIC*FAST SET DENTAL RESTORATIVE2Cleared 510(K)
- K832061LIGHT CURING BONDING AGENT2Cleared 510(K)
- K831484COMPOSI-GLAZE2Cleared 510(K)
- K831559CERTAIN *DENTAL RESTORATIVE2Cleared 510(K)
- K830513FIRST TM2Cleared 510(K)
- K830442PRISMA-FINE2Cleared 510(K)
- K830380MICRODAPT DENTAL RESTORATIVE2Cleared 510(K)
- K823510CURAY ANTERIOR/POSTERIOR RESTORATIVE2Cleared 510(K)
- K823185GAMMA LIGHT CURING DENTAL RESTORATIVE2Cleared 510(K)
- K822453VISIO-OPAQUER2Cleared 510(K)
- K822450AURAFILL* DENTAL RESTORATIVE2Cleared 510(K)
- K821895AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR2Cleared 510(K)
- K820028ZEON COMPOSITE RESIN LIGHT CURE SYS2Cleared 510(K)
- K820182SYBRON/KERR COMMAND2Cleared 510(K)
- K813568ESTILUX POSTERIOR XR2Cleared 510(K)
- K820006ZEON COMPOSITE RESIN SYSTEM2Cleared 510(K)
- K813357CAULK OPAQUER2Cleared 510(K)
- K813090COMPOSITE DENTAL RESTORATIVE MATERIAL2Cleared 510(K)
- K812889ESTILUX POSTERIOR2Cleared 510(K)
- K812545BEAUFILL2Cleared 510(K)
- K812546BEAUDENT2Cleared 510(K)
- K812449ADAPTIC* C.F.S.2Cleared 510(K)
- K812551BEAUCOR2Cleared 510(K)
- K812169VISIO-FIL2Cleared 510(K)
- K812119NIMETIC-DISPERS2Cleared 510(K)
- K811427SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM2Cleared 510(K)
- K811979ATT-1 DENTAL COMPOSITE RESTORATIVE SYS2Cleared 510(K)
- K811669DURAFILL MICROFILL RESTORATIVE MATERIAL2Cleared 510(K)
- K811443ENHANCE DENTAL RESTORATIVE2Cleared 510(K)
- K811363COLTENE DRS DENTAL RESTORATIVE SYSTEM2Cleared 510(K)
- K810969ISOSIT C & B MATERIAL2Cleared 510(K)
- K810595SILUX RESTORATIVE MATERIAL & ENAMEL BOND2Cleared 510(K)
- K810479SUPPORT2Cleared 510(K)
- K803227VISIO-DISPERS2Cleared 510(K)
- K802975ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE2Cleared 510(K)
- K802535HYDROXYLATE DENTAL COMPOSITE RESTROATIVE2Cleared 510(K)
- K802683HELIOSIT2Cleared 510(K)
- K802680ISOPAST-DS2Cleared 510(K)
- K802125ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE2Cleared 510(K)
- K802049NIMETIC-DISPERS2Cleared 510(K)
- K801797SCI-PHARM PAINT-ON RESTORATIVE2Cleared 510(K)
- K801798COMPOSITE RESTORATIVE, PASTE/PASTE TYPE2Cleared 510(K)
- K801732PRISMA-FIL2Cleared 510(K)
- K801529KERR CORE COMPOSITE2Cleared 510(K)
- K801237REIGNING CROWN-BRIDGE/POLYCARB. RESIN2Cleared 510(K)
- K801092PRISMA-FILL2Cleared 510(K)
- K800439ADR COMPOSITE RESTORATIVE2Cleared 510(K)
- K792140COMPOSITE RESTORATIVE, PASTE/TYPE2Cleared 510(K)
- K792303MW 8000-I2Cleared 510(K)
- K791602SCI-PHARM POLIFIL ANTERIOR RESTORATIVE2Cleared 510(K)
- K790823VISIO-DISPERS2Cleared 510(K)
- K791318MIRADAPT* DENTAL RESTORATIVE2Cleared 510(K)
- K790963PAINT-ON RESTORATIVE, LIGHT CURED2Cleared 510(K)
- K790822ANTERIOR/POSTERIOR RESTORATIVE LIQUID2Cleared 510(K)
- K790789COMPOSITE RESTORATIVE, PASTE/PASTE TYPE2Cleared 510(K)
- K790594DENTAL COMPOSITE RESTORATIVE MATERIAL2Cleared 510(K)
- K790585FINESSE2Cleared 510(K)
- K790439CONTACT RESIN2Cleared 510(K)
- K782165PHASEAFILL2Cleared 510(K)
- K781787ISOPLAST2Cleared 510(K)
- K781687AUROFIL2Cleared 510(K)
- K781580PERFIT DENTAL RESTORATIVE COMPOSITE2Cleared 510(K)
- K781293RESTORATIVE SYSTEM PROFILE2Cleared 510(K)
- K780965NEW RESTODENT2Cleared 510(K)
- K780796ZYTRON2Cleared 510(K)
- K780833ESTIC MICROFILL2Cleared 510(K)
- K780832ESTILUX MICROFILL2Cleared 510(K)
- K772279FOTOFILL DENTAL RESTORATIVE2Cleared 510(K)
- K771882REPLICA DENTAL COMPOSITE-RADIOPAQUE2Cleared 510(K)
- K771880REPLICA DENTAL COMPOSIT2Cleared 510(K)
- K771654NIMETICAP2Cleared 510(K)
- K771404NUVA-FIL COMPOSITE RESTORATIVE (MODI.)2Cleared 510(K)
- K771247CORE MATERIAL2Cleared 510(K)
- K771119PASTES, RESTORATIVE & TINTED, DEBTAL2Cleared 510(K)
- K770922DENTAL RESTORATIVE IN CAPSULES2Cleared 510(K)
- K770109ENAMELITE ENAMEL COATING2Cleared 510(K)
- K770055COMPOSITE RESTORATIVE MATERIAL, PRESTIGE2Cleared 510(K)
- K760979COMPOSITE MATERIAL2Cleared 510(K)
- K760417LEE-FILL ULTRAVIOLET-CURED REST. MAT.2Cleared 510(K)
- K760377FILLING, RESIN DENTAL (VYTOL)2Cleared 510(K)
- K760369POWDERLITE2Cleared 510(K)
- 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
- 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
Signum opaque F
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230644
- 510(k) Type
- Traditional
- Applicant
- Kulzer, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/7/2023
- Days to Decision
- 183 days
- Submission Type
- Summary