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
- K253365LuxCreo Flexible Partial Denture Resin2Cleared 510(K)
- K253681TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)2Cleared 510(K)
- K253324UltraPrint-Dental Denture UV2Cleared 510(K)
- K252430Freeprint® denture flex2Cleared 510(K)
- K252035DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)2Cleared 510(K)
- K250302Flexible Partial Resin2Cleared 510(K)
- K242897Partial Flex2Cleared 510(K)
- K250489FP3D2Cleared 510(K)
- K250617Apex Flex2Cleared 510(K)
- K243356Asiga DentaBASE2Cleared 510(K)
- K250946Denture Base Resin DT202Cleared 510(K)
- K243103Denture Base2Cleared 510(K)
- K243336Lucitone Digital Print Denture™ System2Cleared 510(K)
- K242884Additively Manufactured Denture Resin2Cleared 510(K)
- K241089KeyPrint KeyDenture Base2Cleared 510(K)
- K241493Glidewell™ 3DP Denture Base Resin2Cleared 510(K)
- K241071NextDent Jet Denture Base; NextDent Jet Denture Teeth2Cleared 510(K)
- K240688RODIN Titan 3D Resin2Cleared 510(K)
- K233859BASIS FLOW II2Cleared 510(K)
- K233995Ivotion Base Print2Cleared 510(K)
- K233171PF Keep; Cad Cam Keep Block2Cleared 510(K)
- K231578Lucitone Digital Print Denture System2Cleared 510(K)
- K231388NextDent Base2Cleared 510(K)
- K232691Polibond2Cleared 510(K)
- K231389Harvest Dental HD Gum Strip2Cleared 510(K)
- K230445OnX Tough2Cleared 510(K)
- K230410DD medical polymers (PMMA)2Cleared 510(K)
- K222489Harvest Printable Resin2Cleared 510(K)
- K230098Trusana™2Cleared 510(K)
- K230341ACRIFIX2Cleared 510(K)
- K230115Denture Base Resin2Cleared 510(K)
- K220042Dentca Base Premium, Dentca Base Hi-Impact2Cleared 510(K)
- K221678SprintRay High Impact Denture Base2Cleared 510(K)
- K220236V-Print dentbase2Cleared 510(K)
- K220979SprintRay Denture Base2Cleared 510(K)
- K220680Denture Base Polymers2Cleared 510(K)
- K222414TERA HARZ DENTURE2Cleared 510(K)
- K220771Stratasys TrueDent2Cleared 510(K)
- K220743CediTEC2Cleared 510(K)
- K213765Glidewell 3DP Denture Base Resin2Cleared 510(K)
- K213994Flexible Block2Cleared 510(K)
- K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix2Cleared 510(K)
- K210189Pac-Dent Denture Base Resin2Cleared 510(K)
- K210298GR-14 Resin System2Cleared 510(K)
- K203641E-Denture Pro2Cleared 510(K)
- K210828DIOnavi-Denture022Cleared 510(K)
- K200580FotoDent denture2Cleared 510(K)
- K200461Freeprint denture2Cleared 510(K)
- K193623DIOnavi-Denture2Cleared 510(K)
- K191591BB Base 3D printing resin for denture base2Cleared 510(K)
- K190790Flex Fit2Cleared 510(K)
- K191926VITA VIONIC Bond2Cleared 510(K)
- K191497NextDent Denture 3D+2Cleared 510(K)
- K190940Tokuyama Rebase III2Cleared 510(K)
- K191427Halley resin system2Cleared 510(K)
- K190043Halley resin2Cleared 510(K)
- K181331JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White2Cleared 510(K)
- K182422Lucitone Denture Base Materials2Cleared 510(K)
- K181220Juell 3D Volo Base2Cleared 510(K)
- K172764Keymill2Cleared 510(K)
- K172683Yamahachi Pink CAD/CAM Disk2Cleared 510(K)
- K172407Duracetal2Cleared 510(K)
- K170375Nobilplast Denture Resin2Cleared 510(K)
- K170549TOKUYAMA CUREGRACE2Cleared 510(K)
- K162572NextDent Denture, E-Denture2Cleared 510(K)
- K163482Orthodontic Acrylic 22Cleared 510(K)
- K162654mollosil plus2Cleared 510(K)
- K162044Dentca Denture Base II2Cleared 510(K)
- K160918JUVORA Dental Disc, Ceramill PEEK by JUVORA2Cleared 510(K)
- K161330Pour Acrylic2Cleared 510(K)
- K153546PINK CAD/CAM disc2Cleared 510(K)
- K152981JET SET 4 DENTURE REPAIR RESIN2Cleared 510(K)
- K160498Dentivera Milling Disc2Cleared 510(K)
- K153590AvaDent Denture Base Material2Cleared 510(K)
- K152051ClearMet2Cleared 510(K)
- K153253GC Reline II2Cleared 510(K)
- K152270Denture base resin2Cleared 510(K)
- K151646ProTech Plus2Cleared 510(K)
- K151142IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID2Cleared 510(K)
- K143033DENTCA DENTURE BASE2Cleared 510(K)
- K150511Coating Material2Cleared 510(K)
- K150454Acryfree Denture Base Material and Biosens Denture Base Material2Cleared 510(K)
- K143265Acrylic Block2Cleared 510(K)
- K142894TCS Blend2Cleared 510(K)
- K143486Ufi Gel hard C2Cleared 510(K)
- K140758M-PM-DISC (PINK)2Cleared 510(K)
- K141439ORTHODONTIC ACRYLIC (NOT FINALIZED)2Cleared 510(K)
- K140570CHAIRSIDE ATTACHMENT PROCESSING MATERIAL2Cleared 510(K)
- K140146COMFORTSOFT SOFT DENTURE LINER SYSTEM2Cleared 510(K)
- K132725JUVORA DENTQAL DISC2Cleared 510(K)
- K130076PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS2Cleared 510(K)
- K130680ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS2Cleared 510(K)
- K131036YAMAHACHI DENTURE BASE RESINS2Cleared 510(K)
- K123220VERTEX THERMOSENS RIGID2Cleared 510(K)
- K123396I.FLEX BY TCS2Cleared 510(K)
- K122348QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW2Cleared 510(K)
- K113608DEFLEX2Cleared 510(K)
- K113788DEFLEX ACRILATO2Cleared 510(K)
- K111709FOUNDATION DENTAL RESIN2Cleared 510(K)
- K112397ORTHO-JET CRYSTAL2Cleared 510(K)
- K112445SOFRELINER TOUGH S2Cleared 510(K)
- K111832PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID2Cleared 510(K)
- K111178JUELL SOFT CURE2Cleared 510(K)
- K111177JUELL HARD CURE2Cleared 510(K)
- K110440QUICK UP2Cleared 510(K)
- K110037PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID2Cleared 510(K)
- K102874NEW STETIC ACRYLICS2Cleared 510(K)
- K102640VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS2Cleared 510(K)
- K103391IVOBASE HYBRID, IVOBASE HIGH IMPACT2Cleared 510(K)
- K102654VERTEX RAPID SIMPLIFIED2Cleared 510(K)
- K102207FIBER FORCE2Cleared 510(K)
- K102347GRANDTEC2Cleared 510(K)
- K100653JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD2Cleared 510(K)
- K081554TOKUYAMA TISSUECARE2Cleared 510(K)
- K083479BIOCRYL X2Cleared 510(K)
- K081537CFS FLEXIBLE2Cleared 510(K)
- K082180PERMA FIBER,MODEL 441; PERMA MESH, MODEL 4402Cleared 510(K)
- K082153MAJOR.REPAIR2Cleared 510(K)
- K081981LANG DENTAL ACRYLIC PRIMER2Cleared 510(K)
- K081884MAJOR.BASE 202Cleared 510(K)
- K081514TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER2Cleared 510(K)
- K072851POLYSTAR 79 DENTURE BASE RESIN2Cleared 510(K)
- K073040SMH FLEX S2Cleared 510(K)
- K072479FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD2Cleared 510(K)
- K072580JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,232Cleared 510(K)
- K072402FLEX-STAR V2Cleared 510(K)
- K072713ION DENTAL RESIN SYSTEM2Cleared 510(K)
- K071245TALON AND REVERE2Cleared 510(K)
- K070697COE SOFT2Cleared 510(K)
- K070698COE COMFORT2Cleared 510(K)
- K063626DURAFLEX2Cleared 510(K)
- K063170TENDER FIBER2Cleared 510(K)
- K061735INFIBRA, MODEL 12002Cleared 510(K)
- K061580ECLIPSE WAX REMOVER2Cleared 510(K)
- K061501FLEXO DENTAL RESIN MATERIAL2Cleared 510(K)
- K053060TCS UNBREAKABLE2Cleared 510(K)
- K060844SILKLINE SOFT RELINING KIT, MODEL 28-1001002Cleared 510(K)
- K053516MUCOHARD2Cleared 510(K)
- K053328BIOSPLINT SPLINTING RIBBON2Cleared 510(K)
- K052780DENTAPLAST HOT, MODEL 16-XXX2Cleared 510(K)
- K052073FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 20002Cleared 510(K)
- K051358NATURE-CRYL HI PLUS2Cleared 510(K)
- K043504PALAIMPACT2Cleared 510(K)
- K043295VERSYO.DIRECT2Cleared 510(K)
- K042931TUF LINK SILICONE RELINER2Cleared 510(K)
- K040881METACRYL2Cleared 510(K)
- K034024TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS2Cleared 510(K)
- K033632VARIFLEX2Cleared 510(K)
- K033472TESCERA U-BAR AND BARRELS2Cleared 510(K)
- K033629VERSYO.BOND2Cleared 510(K)
- K033020IMPAK ACRYLIC REPAIR RESIN LIQUID2Cleared 510(K)
- K032892MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM2Cleared 510(K)
- K032773DIAMOND D HIGH IMPACT DENTURE ACRYLIC2Cleared 510(K)
- K031070CARBON FIBER BRIDGE, MODEL 287572Cleared 510(K)
- K030916UFI GEL HARD C2Cleared 510(K)
- K030663TOKUYAMA SOFRELINER TOUGH2Cleared 510(K)
- K030072EVERSTICK PERIO2Cleared 510(K)
- K022641TOKUYAMA REBASE II2Cleared 510(K)
- K021437SECURE SOFT2Cleared 510(K)
- K021586SECURE RELINE/PICKUP MATERIAL2Cleared 510(K)
- K021121AROMACRYL2Cleared 510(K)
- K021126EVERSTICK ORTHO2Cleared 510(K)
- K013881RIBBOND - TRIAXIAL2Cleared 510(K)
- K012882BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 1200602Cleared 510(K)
- K011799EVERSTICKNET2Cleared 510(K)
- K011788EVERSTICK2Cleared 510(K)
- K011820DENTORIUM CONVERTIBLE ACRYLIC2Cleared 510(K)
- K011762HI-WAVE; POUR-PLUS2Cleared 510(K)
- K011560TRUBYTE DENTURE BASE RESIN SYSTEM2Cleared 510(K)
- K011277HARD RELINER2Cleared 510(K)
- K010800VERSYO.COM2Cleared 510(K)
- K003334STICK NET2Cleared 510(K)
- K003333STICK2Cleared 510(K)
- K002048JBC OPAQUE AND GLITTER2Cleared 510(K)
- K001640BIOSOFT RESIN2Cleared 510(K)
- K001463SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 01562Cleared 510(K)
- K992176EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL2Cleared 510(K)
- K993827UFI GEL HARD2Cleared 510(K)
- K993717ENIGMA HI-BASE DENTURE BASE MATERIAL2Cleared 510(K)
- K991687MODIFICATION TO LINER II: SOFT RELINE LIQUID2Cleared 510(K)
- K992956LUCITONE FRS FLEXIBEL DENTAL RESIN2Cleared 510(K)
- K992609HYDRO-CAST SILICONE SOFT-LINER, MODEL 684002Cleared 510(K)
- K991577NIC TONE ACRYLIC RESINS2Cleared 510(K)
- K991996IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR2Cleared 510(K)
- K991774ACRON MC MODIFICATION2Cleared 510(K)
- K990736GC RELINE SOFT/EXTRA SOFT2Cleared 510(K)
- K990763VITRON M2Cleared 510(K)
- K991220VITRON H2Cleared 510(K)
- K990699ORTHO-GLOW GLITTER2Cleared 510(K)
- K983461UNI-FLEX RESIN2Cleared 510(K)
- K990056JELDENT MULTICRYL2Cleared 510(K)
- K990448THE.R.MO.FREE2Cleared 510(K)
- K984365GC UNIFAST TRAD2Cleared 510(K)
- K984467FUSICRYL2Cleared 510(K)
- K984483A-SOFT RELINER2Cleared 510(K)
- K981862RESIN 42Cleared 510(K)
- K984341STERNVANTAGE VARNISH LC, MODEL 2210012Cleared 510(K)
- K983547PROTECH PLUS2Cleared 510(K)
- K983876MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC2Cleared 510(K)
- K983357MUCOPREN SOFT RELINING SYSTEM2Cleared 510(K)
- K981691SILICONE SOFT RELINE2Cleared 510(K)
- K982695GC RELINE2Cleared 510(K)
- K981861LINER 1:HARD RELINE LIQUID2Cleared 510(K)
- K982537TOKUYAMA SOFRELINER2Cleared 510(K)
- K981448KERR HARD DENTURE RELINE MATERIAL2Cleared 510(K)
- K980616PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)2Cleared 510(K)
- K974865CSR2Cleared 510(K)
- K974160BRUXTRAK MATERIAL2Cleared 510(K)
- K974727JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR2Cleared 510(K)
- K974772UFI GEL C2Cleared 510(K)
- K973542MASKY2Cleared 510(K)
- K972553LANG DENTAL RESIN A97 FIBRED PINK2Cleared 510(K)
- K972573LIQCRYLIC PRO DENTAL RESIN2Cleared 510(K)
- K971138DINABASE (TM)2Cleared 510(K)
- K970522MYERSON'S ECONOMY DENTURE BASE MATERIAL2Cleared 510(K)
- K964040TRUBYTE SOFT RELINE SYSTEM2Cleared 510(K)
- K963736SOFT DENTURE REBASING RESIN2Cleared 510(K)
- K963144GC BASELINE2Cleared 510(K)
- K962333V.R.S. DENTURE RESIN MATERIAL2Cleared 510(K)
- K962374FIBER-SPLINT ML MULTILAYER2Cleared 510(K)
- K961995QUICKSPLINT2Cleared 510(K)
- K961200BOSWORTH LIQUID RESIN II2Cleared 510(K)
- K953589TOKUYAMA SOFT RELINING2Cleared 510(K)
- K954637AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER2Cleared 510(K)
- K954810MYERSON IR DENTURE BASE2Cleared 510(K)
- K954689CONNECT2Cleared 510(K)
- K953743PALASPLINT2Cleared 510(K)
- K953381PROP. CONQUEST C&B VLC GLAZE/SEALANT2Cleared 510(K)
- K953119BOSWORTH RESIN II2Cleared 510(K)
- K952351PRECISE DENTURE BASE RESIN2Cleared 510(K)
- K944466SEALDENT2Cleared 510(K)
- K943905PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER2Cleared 510(K)
- K946317HARRY J. BOSWORTH RESIN I.2Cleared 510(K)
- K945711EXCEL-P FORMULA AUTO-CURE DENTURE BASE2Cleared 510(K)
- K942562PROSTHOFLEX2Cleared 510(K)
- K941925ORTHO-JET ACRYLIC RESIN - SPARKLE2Cleared 510(K)
- K940565COE-SOFT LC2Cleared 510(K)
- K935261KOOLINER II2Cleared 510(K)
- K930939REBARON LC2Cleared 510(K)
- K934019EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO2Cleared 510(K)
- K933468MYERSON'S PERMASOFT SOFT RELINE MATERIAL2Cleared 510(K)
- K934248ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER2Cleared 510(K)
- K933831PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.2Cleared 510(K)
- K926406DUAL CURE RELINE MATERIAL2Cleared 510(K)
- K925062PERMAFLEX PERMANENT SOFT DENTURE RELINER2Cleared 510(K)
- K925275SOFT DENTURE RELINE MATERIAL ELASTOLINE2Cleared 510(K)
- K924422PALABOND2Cleared 510(K)
- K915898PALADUR2Cleared 510(K)
- K912990CONVERBASE2Cleared 510(K)
- K920557WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX2Cleared 510(K)
- K912993WILDE DENTURE RESINS2Cleared 510(K)
- K915377SR-IVOCAP PLUS2Cleared 510(K)
- K912991WILDE AUXILIARIES2Cleared 510(K)
- K913655PROBASE HOT AND PROBASE COLD2Cleared 510(K)
- K913699MODERN MATERIALS ORTHODONTIC RESIN2Cleared 510(K)
- K913698ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL2Cleared 510(K)
- K913040RIBBOND(TM)2Cleared 510(K)
- K910795COMFOR-DENT DENTURE LINER2Cleared 510(K)
- K910465MELIODENT, DENTURE RESIN2Cleared 510(K)
- K905702NEW TRIAD TRANSHEET DENTURE BASE MATERIAL2Cleared 510(K)
- K902972FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)2Cleared 510(K)
- K902115PALAPRESS(R) VARIO RESIN2Cleared 510(K)
- K901621NEW PER-FIT(R) IMPROVED2Cleared 510(K)
- K901789PALADON(R) 652Cleared 510(K)
- K900799COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS2Cleared 510(K)
- K900301NOVUS BONDING AGENT2Cleared 510(K)
- K896980PALFIQUE LIGHT LINER2Cleared 510(K)
- K896981TOKUSO REBASE2Cleared 510(K)
- K896139SR-IVOSEAL2Cleared 510(K)
- K896130SR-IVOCAP2Cleared 510(K)
- K896719PRIMER-P ADHESIVE AGENT2Cleared 510(K)
- K895714ORTHO-KEV APPLIANCE REINFORCING SYSTEM2Cleared 510(K)
- K895742LITELINE VLC SOFT RELINE2Cleared 510(K)
- K895222CURAY-FORM2Cleared 510(K)
- K894564RELIANCE LIGHT CURE RETAINER ACRYLIC2Cleared 510(K)
- K892452PALASEAL(R)2Cleared 510(K)
- K890830DENTURE RESIN2Cleared 510(K)
- K884865PERMASEAL AND DENTURE SEAL2Cleared 510(K)
- K884751DANSU PERMANENT CHAIR SOFT LINER2Cleared 510(K)
- K883799BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN2Cleared 510(K)
- K882482TRIAD ORTHODONTIC GEL2Cleared 510(K)
- K881245DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER2Cleared 510(K)
- K8740252ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN2Cleared 510(K)
- K873738ACRYLIC BASE DENTURE MATERIALS2Cleared 510(K)
- K871849LIGHT CURE DENTURE GLAZE2Cleared 510(K)
- K871497LINER OR GSRI-PNF2Cleared 510(K)
- K871038LUTEMOLL (BIOPLAST)2Cleared 510(K)
- K871312FIBREFLEX2Cleared 510(K)
- K870908STEADY RESIN2Cleared 510(K)
- K863630AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL2Cleared 510(K)
- K864708SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN2Cleared 510(K)
- K870148DURA ORTHO ACRYLIC2Cleared 510(K)
- K862557AUSTENAL ACUSOFT SOFT LINER2Cleared 510(K)
- K864757MODIFIED VINYLAC PRESS PACK DENTURE RESIN2Cleared 510(K)
- K864709IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL2Cleared 510(K)
- K863324TRIAD IMPACT2Cleared 510(K)
- K862558AUSTENAL ACUPAC HI DENTURE BASE MATERIAL2Cleared 510(K)
- K861239ACRYLIC SOLDER2Cleared 510(K)
- K853094EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA2Cleared 510(K)
- K852741DURA CONDITIONER2Cleared 510(K)
- K850650DENTAL ACRYLIC POLYMERS2Cleared 510(K)
- K842476CREDENT RADIOPAQUE CROWN & BRIDE2Cleared 510(K)
- K842477CREDENT RADIOPAQUE DENTURE RESIN2Cleared 510(K)
- K842576CLEAR LINER2Cleared 510(K)
- K833270ASTRON 77 INJECTION DENTURE RESIN2Cleared 510(K)
- K840405BOSWORTH DENT-ALL2Cleared 510(K)
- K840548RESIL2Cleared 510(K)
- K834409DENTURE BASE RESIN2Cleared 510(K)
- K834435CROWN & BRIDGE RESIN2Cleared 510(K)
- K831095ROYALE II2Cleared 510(K)
- K831647DENTURE RELINING, REPAIR/REBASING RESIN2Cleared 510(K)
- K831269VINYLAC PRESS-PACK DENTURE RESIN2Cleared 510(K)
- K823568POLY-TONE DENTURE BASE RESIN2Cleared 510(K)
- K821217REIGNING DENTURE2Cleared 510(K)
- K821230SOFTIC 492Cleared 510(K)
- K820673SELF-CURING HARD DENTURE LINER2Cleared 510(K)
- K810869SILICONE ELASTOMER KIT2Cleared 510(K)
- K810687SR-IVOCAP2Cleared 510(K)
- K810094DENTURE RUBBER BASE MATERIAL2Cleared 510(K)
- K802490REIGNING DENTURE2Cleared 510(K)
- K802491REIGNING REPAIR EPOXY RESIN2Cleared 510(K)
- K801234REIGNING DENTURE MADE OF POLYCARB. RESIN2Cleared 510(K)
- K800458ORTHODONTICARTIDE2Cleared 510(K)
- K800400MAXUM DENTURE RESIN2Cleared 510(K)
- K792427PERMA-CRYL 202Cleared 510(K)
- K792042DENTURE BASE RESIN2Cleared 510(K)
- K790325REPRODENT2Cleared 510(K)
- K780786DENTURE RELINE MATERIAL2Cleared 510(K)
- 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
Coating Material
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K150511
- 510(k) Type
- Traditional
- Applicant
- Sun Medical Co., Ltd.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/27/2015
- Days to Decision
- 89 days
- Submission Type
- Summary