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
- 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
- K242749TopCEM Ceramic Primer Ceramic Coupling Agent2Cleared 510(K)
- K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)2Cleared 510(K)
- K240153Ceramic Etchant (HF-5 and HF-9)2Cleared 510(K)
- K241445K-Bond Universal2Cleared 510(K)
- K241056Light Cure Adhesive2Cleared 510(K)
- K240743Peak Universal Bond2Cleared 510(K)
- K231039CLEARFIL Universal Bond Quick 22Cleared 510(K)
- K232978DX. Bond V Dental Bonding Adhesive2Cleared 510(K)
- K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal2Cleared 510(K)
- K230465Hi-Bond Universal2Cleared 510(K)
- K230009EZ Bond Universal2Cleared 510(K)
- K222830Rainbow 3602Cleared 510(K)
- K221450Phosphoric Acid Etching Gel2Cleared 510(K)
- K222357DenMat Glutaraldehyde Desensitizer2Cleared 510(K)
- K221033UniPrime A, UniPrime E, UniPrime E/C2Cleared 510(K)
- K220804Dia-X Bond Universal2Cleared 510(K)
- K210804Adhese Universal DC, Cention Primer2Cleared 510(K)
- K213965BeautiBond Xtreme2Cleared 510(K)
- K213401DIAPLUS Universal2Cleared 510(K)
- K213093STEP-1 PumEtch2Cleared 510(K)
- K210186PacBond One2Cleared 510(K)
- K210945Ultra SEP2Cleared 510(K)
- K203760Tokuyama Universal Bond II2Cleared 510(K)
- K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose2Cleared 510(K)
- K200153Bright Bond Universal2Cleared 510(K)
- K200682BZF-292Cleared 510(K)
- K201787Light Cure Dental Adhesive2Cleared 510(K)
- K200462EtchPro Etching Gel2Cleared 510(K)
- K192392DiaPlus2Cleared 510(K)
- K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit2Cleared 510(K)
- K183424Ambar, Ambar APS, Ambar Universal APS2Cleared 510(K)
- K191656Zipbond2Cleared 510(K)
- K192961ADH192Cleared 510(K)
- K191523Visalys Restorative Primer2Cleared 510(K)
- K191524Visalys Tooth Primer2Cleared 510(K)
- K183391Novidia Universal Bond2Cleared 510(K)
- K180917GC Acrylic Primer2Cleared 510(K)
- K182162OptiBond eXTRa Universal2Cleared 510(K)
- K181910BracePaste MTP Light Cure Primer2Cleared 510(K)
- K181476Prime&Bond active Universal Adhesive2Cleared 510(K)
- K180803BeautiBond Universal2Cleared 510(K)
- K180802Meta P&Bond2Cleared 510(K)
- K172953Acid Etchant2Cleared 510(K)
- K172977Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel2Cleared 510(K)
- K171226TOKUYAMA UNIVERSAL BOND2Cleared 510(K)
- K172176Parkell Universal Adhesive2Cleared 510(K)
- K172106SHOFU MZ Primer Plus2Cleared 510(K)
- K161077RnD TE and RnD SE2Cleared 510(K)
- K161891HC Primer2Cleared 510(K)
- K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack2Cleared 510(K)
- K161051All-Bond Universal w/BAC (not finalized)2Cleared 510(K)
- K152243One Coat 7 Universal2Cleared 510(K)
- K152110e-1 etchants2Cleared 510(K)
- K151619Prime&Bond Elect Universal Dental Adhesive2Cleared 510(K)
- K151518BRUSH&BOND PLUS2Cleared 510(K)
- K150703CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)2Cleared 510(K)
- K150933iBond Universal & iBond Ceramic Primer2Cleared 510(K)
- K150696Jade 37% Phosphoric Acid Etchant Gel2Cleared 510(K)
- K143140G-Premio BOND2Cleared 510(K)
- K150164Monobond Etch & Prime2Cleared 510(K)
- K142848EAZY PRIMER2Cleared 510(K)
- K141839PREMIER ETCH2Cleared 510(K)
- K140537TENURE4G2Cleared 510(K)
- K141610FUTURABOND M+2Cleared 510(K)
- K131734ALL-BOND UNIVERSAL SC (NOT FINALIZED)2Cleared 510(K)
- K133318ADHESE UNIVERSAL2Cleared 510(K)
- K132923FUSION SINGLE LINK2Cleared 510(K)
- K133078K-ETCHANT SYRINGE; NEEDLE TIP (E)2Cleared 510(K)
- K132450CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND2Cleared 510(K)
- K131043APEX UNIVERSAL ADHESIVE2Cleared 510(K)
- K131357PEAK Z2Cleared 510(K)
- K131430CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL2Cleared 510(K)
- K131049ZRP2Cleared 510(K)
- K131212PREMIER CERAMIC PRIMER2Cleared 510(K)
- K131432CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL2Cleared 510(K)
- K131248ETCH GEL2Cleared 510(K)
- K130486FUTURABOND UNIVERSAL2Cleared 510(K)
- K122522DENTOETCH QUICKBOND BOND ACTIVATOR2Cleared 510(K)
- K123278IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF2Cleared 510(K)
- K123119CERARESIN BOND2Cleared 510(K)
- K120620CLEAN AND BOOST2Cleared 510(K)
- K120767ES BOND2Cleared 510(K)
- K120213ETCH-RITE SUPREME2Cleared 510(K)
- K112597SEITY 37% PHOSPHORIC ACID ETCHANT GEL2Cleared 510(K)
- K112118DREAMBOND2Cleared 510(K)
- K111980CLEARFIL TRI-S BOND PLUS2Cleared 510(K)
- K111975CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK2Cleared 510(K)
- K111876Z BOND, PRELUDE ONE2Cleared 510(K)
- K110403PROLINK ADHESIVES (PROLINK, PROLINK SE)2Cleared 510(K)
- K111431B1P ADHESIVE2Cleared 510(K)
- K110302ADHESIVE EXL-7592Cleared 510(K)
- K110252BEAUTIBOND MULTI PR PLUS2Cleared 510(K)
- K110235BEAUTIBOND MULTI2Cleared 510(K)
- K102254DMP SINGLE BONDING2Cleared 510(K)
- K102844ALL-BOUND 32Cleared 510(K)
- K101485ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E2Cleared 510(K)
- K101423OPTIBOND XTR2Cleared 510(K)
- K100752PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)2Cleared 510(K)
- K100347OPTIBOND SE2Cleared 510(K)
- K093014AMERICAN DENTAL PRODUCTS SE BONDEASY2Cleared 510(K)
- K093744EXCITE F AND EXCITE DSC2Cleared 510(K)
- K092616ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-000452Cleared 510(K)
- K091705PRIMER PLUS2Cleared 510(K)
- K091300ASCENT PORCELAIN PRIMER, MODEL 006-00078, 006000792Cleared 510(K)
- K090941ADHESE ONE F2Cleared 510(K)
- K090826MONOBOND PLUS2Cleared 510(K)
- K090106PRELUDE ONE2Cleared 510(K)
- K083652IBOND TOTAL ETCH2Cleared 510(K)
- K082744BEAUTIBOND2Cleared 510(K)
- K082753FUTURABOND M/FUTURABOND M SINGLE DOSE2Cleared 510(K)
- K082768G-BOND PLUS2Cleared 510(K)
- K072480GENERATION 8 SE ADHESIVE2Cleared 510(K)
- K071688RELIANCE S.E.P.2Cleared 510(K)
- K071500NANO-BOND II ADHESIVE SYSTEM2Cleared 510(K)
- K071131UNO2Cleared 510(K)
- K071260HERMES BOND 32Cleared 510(K)
- K071452FL BOND II2Cleared 510(K)
- K070723FUTURABOND DC/SINGLE DOSE2Cleared 510(K)
- K070956SEA2 SELF ETCH ADHESIVE2Cleared 510(K)
- K070646ADHESE ONE2Cleared 510(K)
- K070413ASCENT UNIVERSAL ADHESIVE, MODEL 006-000282Cleared 510(K)
- K070215TOKUYAMA BOND FORCE2Cleared 510(K)
- K063444TOTAL ETCH BONDING AGENT2Cleared 510(K)
- K070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE2Cleared 510(K)
- K063780ACE BOND SE2Cleared 510(K)
- K063558PEAK SE, MODEL 51352Cleared 510(K)
- K063557PEAK BOND, MODEL 51332Cleared 510(K)
- K063062HKBOND 20062Cleared 510(K)
- K062713ADHESIVE DC ACTIVATOR2Cleared 510(K)
- K061998PREMIER SELF-ETCHING BOND ENHANCER2Cleared 510(K)
- K062382CLEARFIL DC BOND2Cleared 510(K)
- K061611BOSWORTH DENTIN RESIN2Cleared 510(K)
- K060882EXCEL BOND DC, MODEL 28-2001002Cleared 510(K)
- K061981SURPASS2Cleared 510(K)
- K061322PORCELAIN PRIMER2Cleared 510(K)
- K060684ADPER PROMPT, ADPER PROMPT L-POP2Cleared 510(K)
- K060469OPTIBOND ALL-IN-ONE2Cleared 510(K)
- K053103INTERFACE2Cleared 510(K)
- K053392FUTURABOND NR SINGLE DOSE2Cleared 510(K)
- K052699VERSA-LINK PORCELAIN BONDING SYSTEM2Cleared 510(K)
- K052501MULTIPLE RESIN TOOTH BONDING AGENT2Cleared 510(K)
- K052189REVENEER CERAMIC REPAIR SYSTEM2Cleared 510(K)
- K051796CLEARFIL TRI-S BOND SINGLE DOSE2Cleared 510(K)
- K051707ECLIPSE BONDING AGENT2Cleared 510(K)
- K051463XENO ADHESIVE WITH ACTIVATOR2Cleared 510(K)
- K051050SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 6440922Cleared 510(K)
- K051006IBOND NEXT GENERATION2Cleared 510(K)
- K050647ALL-IN-ONE2Cleared 510(K)
- K050331ADHESIVE 12Cleared 510(K)
- K043170BOSWORTH BOND2Cleared 510(K)
- K050386PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM2Cleared 510(K)
- K043043HERMES BOND 22Cleared 510(K)
- K043562BC PLUS2Cleared 510(K)
- K042913CLEARFIL TRI-S BOND2Cleared 510(K)
- K042806QUADRANT UNIT-1-BOND2Cleared 510(K)
- K042614S&C-SELF ETCH PR-BOND2Cleared 510(K)
- K041680ORAJEL ADVANCED TOOTH DESENSITIZER2Cleared 510(K)
- K042670FUTURABOND NR2Cleared 510(K)
- K040079M.L. PRIMER2Cleared 510(K)
- K041960COMPOSITE/COMPOMER REPAIR KIT2Cleared 510(K)
- K041471G-BOND2Cleared 510(K)
- K040952PRELUDE2Cleared 510(K)
- K041343XENO NM LIGHT CURED DENTAL ADHESIVE2Cleared 510(K)
- K040857MODIFICATION TO ADPER PROMPT2Cleared 510(K)
- K033974HERMES BOND2Cleared 510(K)
- K033938CLEARFIL PROTECT BOND2Cleared 510(K)
- K033760ONE COAT SE BOND2Cleared 510(K)
- K032953EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT2Cleared 510(K)
- K032626PERMAQUICK SE BONDING SYSTEM2Cleared 510(K)
- K032179COMP. E2Cleared 510(K)
- K031915PULPDENT ETCH-RITE ROYALE2Cleared 510(K)
- K031444OPTIBOND FL2Cleared 510(K)
- K030844FINAL VARNISH LC2Cleared 510(K)
- K030743ETCHANT 40%2Cleared 510(K)
- K024356CLEARFIL SILANE KIT2Cleared 510(K)
- K023842CLEARFIL SE BOND PLUS2Cleared 510(K)
- K023776XENO III DENTAL ADHESIVE2Cleared 510(K)
- K022973ADHESIVE 142Cleared 510(K)
- K023042PQ12Cleared 510(K)
- K022612IBOND GLUMA INSIDE2Cleared 510(K)
- K021427CLEARFIL SA PRIMER2Cleared 510(K)
- K020514PULPDENT GLAZE II2Cleared 510(K)
- K020570SIMPLICITY2Cleared 510(K)
- K020499BOND-3 ADHESIVE2Cleared 510(K)
- K020303XR PRIMER 22Cleared 510(K)
- K020946ADPER PROMPT2Cleared 510(K)
- K020239TOUCH&BOND-PLUS2Cleared 510(K)
- K014027OPTIBOND SOLO PLUS 42Cleared 510(K)
- K013543BOND-1 C & B2Cleared 510(K)
- K013997UNIFIL BOND2Cleared 510(K)
- K020050ENAMEL BONDING SYSTEM2Cleared 510(K)
- K013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)2Cleared 510(K)
- K013584EXCITE SELF ETCH2Cleared 510(K)
- K013519SIMPLE2Cleared 510(K)
- K012082OPTIBOND SOLO PLUS ACTIVATOR2Cleared 510(K)
- K012734CLEARFIL NEW BOND2Cleared 510(K)
- K012729CLEARFIL REPAIR2Cleared 510(K)
- K012730CLEARFIL PORCELAIN BOND ACTIVATOR2Cleared 510(K)
- K012442MODIFICATION TO CLEARFIL SE BOND2Cleared 510(K)
- K012440MODIFICATION TO CLEARFIL LINER BOND 2V2Cleared 510(K)
- K012432MODIFICATION TO CLEARFIL PHOTO BOND2Cleared 510(K)
- K012436MODIFICATION TO ALLOY PRIMER2Cleared 510(K)
- K012322OPTIBOND 22Cleared 510(K)
- K010547VERTEX SEALAND L/C ORTHODONTIC SEALANT2Cleared 510(K)
- K010415ISODAN2Cleared 510(K)
- K011490MODIFICATION TO EXCITE2Cleared 510(K)
- K011167XSE2Cleared 510(K)
- K003293EXCITE DSC2Cleared 510(K)
- K003011SELF ETCH BONDING PRIMER2Cleared 510(K)
- K003153SOLOBOND PLUS2Cleared 510(K)
- K002502CERAM-PRIME2Cleared 510(K)
- K001914CLEARFIL REPAIR2Cleared 510(K)
- K001494MODIFICATION TO PROMPT L-POP2Cleared 510(K)
- K000189PQ12Cleared 510(K)
- K000954KERR GEL ETCHANT2Cleared 510(K)
- K994359BOND 1 C & B2Cleared 510(K)
- K994302RESIN TOOTH BONDING AGENT2Cleared 510(K)
- K993917TOKUYAMA ONE-UP-BOND F2Cleared 510(K)
- K993683PULPDENT UNO-DUO2Cleared 510(K)
- K993013SURE BOND2Cleared 510(K)
- K992838ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE2Cleared 510(K)
- K992879ECUSIT COMPOSITE REPAIR2Cleared 510(K)
- K992985GLUMA COMFORT BOND2Cleared 510(K)
- K992292GLUMA COMFORT BOND + DESENSITIZER2Cleared 510(K)
- K992048MODIFICATION OF PROMPT L-POP2Cleared 510(K)
- K991808OPTIBOND SOLO PLUS 22Cleared 510(K)
- K990534EXCITE2Cleared 510(K)
- K990498OPTIBOND SOLO PLUS2Cleared 510(K)
- K984503ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-0002Cleared 510(K)
- K990143GLUMA ONE BOND2Cleared 510(K)
- K990040CLEARFIL SE BOND2Cleared 510(K)
- K984246PROMPT L-POP2Cleared 510(K)
- K983414EVERBOND2Cleared 510(K)
- K983668MODIFICATION OF PQ12Cleared 510(K)
- K983545QUADRANT UNIBOND2Cleared 510(K)
- K982394PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM2Cleared 510(K)
- K982007TRUBYTE DENTURE BOND DENTURE BONDING AGENT2Cleared 510(K)
- K981514GC FUJI BOND LC2Cleared 510(K)
- K981383ALLOYBOND2Cleared 510(K)
- K974906ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM2Cleared 510(K)
- K980539SOLOBOND M2Cleared 510(K)
- K973002HURRISEAL DENTIN DESENSITIZER2Cleared 510(K)
- K974786PREPQUICK2Cleared 510(K)
- K973285D/SENSE-T2Cleared 510(K)
- K974390GLUMA ONE BOND2Cleared 510(K)
- K974486CLEARFIL LINER BOND 2V2Cleared 510(K)
- K974283PQ 12Cleared 510(K)
- K974089ALLOY PRIMER2Cleared 510(K)
- K973092STAE2Cleared 510(K)
- K973185AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE2Cleared 510(K)
- K973245TOKUSO REBASE MR. BOND2Cleared 510(K)
- K9717332 BOND 22Cleared 510(K)
- K972101SOLITAIRE2Cleared 510(K)
- K972858KERR NEXUS ONE BOTTLE ADHESIVE2Cleared 510(K)
- K973388DENTIN CONDITIONING AND ADHESIVE (BOND 1)2Cleared 510(K)
- K972421EASY BOND2Cleared 510(K)
- K972594METALPRIMER II2Cleared 510(K)
- K971121ENCORE BOND2Cleared 510(K)
- K970848SILOC SYSTEM2Cleared 510(K)
- K964867HYBRID RESIN COMPOSITE2Cleared 510(K)
- K964038CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG2Cleared 510(K)
- K965138DENTINSENSE B/C2Cleared 510(K)
- K964735DENTINSENSE2Cleared 510(K)
- K964525PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR2Cleared 510(K)
- K964133AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE2Cleared 510(K)
- K964140GLUMA CONDITIONER2Cleared 510(K)
- K964000BISFIL 2B2Cleared 510(K)
- K962812GLUMA DESENSITIZER/GLUMA 3 PRIMER2Cleared 510(K)
- K962428EBS (ESPE BONDING SYSTEM)2Cleared 510(K)
- K9627853M DENT SYSTEM2Cleared 510(K)
- K962515KERR ADVANCED ADHESIVE2Cleared 510(K)
- K962348PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT2Cleared 510(K)
- K960696PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM2Cleared 510(K)
- K962277SELF CURE BONDING AGENT2Cleared 510(K)
- K961822WET-PREP2Cleared 510(K)
- K960697ULTRACID AND ULTRACID F DISINFECTING SOLUTION2Cleared 510(K)
- K960823PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT2Cleared 510(K)
- K960365ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)2Cleared 510(K)
- K955328CONFI-BOND2Cleared 510(K)
- K960879AMALGAMIBOND PLUS2Cleared 510(K)
- K955740GLUFLORMA2Cleared 510(K)
- K955279D-SENSE2Cleared 510(K)
- K954708SILANE PRIMER2Cleared 510(K)
- K954133AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER2Cleared 510(K)
- K953612IMPERVA FLUOROBOND2Cleared 510(K)
- K953613IMPERVA ENSURABOND2Cleared 510(K)
- K953504MICROPRIME2Cleared 510(K)
- K953405HEMA-BENZ2Cleared 510(K)
- K953166FUJI BOND LC2Cleared 510(K)
- K953476MULTI-PRIME AKA/MONO-PRIME2Cleared 510(K)
- K953859BOND-IT DUAL CURE ACTIVATOR2Cleared 510(K)
- K953592REVOLUTION BOND2Cleared 510(K)
- K953527PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS2Cleared 510(K)
- K952124ABOND2Cleared 510(K)
- K952123MS EMULSION2Cleared 510(K)
- K951867PERMAQUIK BONDING PRIMER2Cleared 510(K)
- K951864PRIME & BOND DIRECT COMPOSITE BONDING AGENT2Cleared 510(K)
- K951583PERMAQUIK BONDING PRIMER2Cleared 510(K)
- K951220HEMA-GLU2Cleared 510(K)
- K950905C&B-METABOND RADIOPAQUE POWDER2Cleared 510(K)
- K950860PERMALUTE2Cleared 510(K)
- K945604ECLIPTOMER2Cleared 510(K)
- K945112PULPDENT DUAL CURE UNFILLED BONDING RESIN2Cleared 510(K)
- K933360GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER2Cleared 510(K)
- K943738OPTIBOND-D2Cleared 510(K)
- K943373PERMAGEN F/DC2Cleared 510(K)
- K943165CLEARFIL PHOTO BOND2Cleared 510(K)
- K943170CLEARFIL LINER BOND 22Cleared 510(K)
- K943167CLEARFIL NEW BOND2Cleared 510(K)
- K943166CLEARFIL LINER BOND SYSTEM2Cleared 510(K)
- K942017V-PRIMER2Cleared 510(K)
- K942493SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM2Cleared 510(K)
- K941572FLUORIDE-PSA PRIME/ADHESIVE2Cleared 510(K)
- K940513OPTIBOND2Cleared 510(K)
- K936222DENTIN CONDITIONING AND ADHESIVE SYSTEM2Cleared 510(K)
- K935961GC FUJI COAT LC2Cleared 510(K)
- K935735ATTACHMENT BOND2Cleared 510(K)
- K936100CLEARFIL LINER BOND 22Cleared 510(K)
- K934596BISCO DUO LINK D/C LUTING COMPOSITE2Cleared 510(K)
- K934690KERR OPTIBOND, MODIFICATION2Cleared 510(K)
- K931710PULPDENT DENTAL BOND ENHANCER 2-B2Cleared 510(K)
- K932379ALL-BOND(R) JR.2Cleared 510(K)
- K931870BONDING RESIN PRODUCT LINE2Cleared 510(K)
- K931838DENTHESIVE II2Cleared 510(K)
- K931812NEW DENTINE ADHESIVE2Cleared 510(K)
- K930504NEW DENTIN PRIMER2Cleared 510(K)
- K930989PULPDENT UNFILLED DUAL CURE BONDING RESIN2Cleared 510(K)
- K924378RESTOBOND 42Cleared 510(K)
- K913581WILDE ADHESIVE BONDING SYSTEM2Cleared 510(K)
- K925404CLEARFIL PORCELAIN BOND ACTIVATOR2Cleared 510(K)
- K924670DENTIN RELIEF2Cleared 510(K)
- K924181POLIBOND2Cleared 510(K)
- K923842BISCO UNIVERSAL BOND-32Cleared 510(K)
- K923546OPTIBOND2Cleared 510(K)
- K922615COLTENE A.R.T. BOND2Cleared 510(K)
- K921701DURAFILL BOND2Cleared 510(K)
- K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM2Cleared 510(K)
- K915511MIRAGE COMPLETE KIT AND MIRAGE ABC KIT2Cleared 510(K)
- K915830PRISMA UNIVERSAL BOND(R) 32Cleared 510(K)
- K910069SR-ISOSIT SPECTRA LINK SYSTEM2Cleared 510(K)
- K913965ESPE(R) -SIL2Cleared 510(K)
- K913946IMPERVA DUAL2Cleared 510(K)
- K911282PULPDENT ENAMEL BONDING AGENT2Cleared 510(K)
- K912707CLEARFIL LINER BOND SYSTEM2Cleared 510(K)
- K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT2Cleared 510(K)
- K911525TOKUSO LIGHT BOND2Cleared 510(K)
- K910860ALL-BOND 22Cleared 510(K)
- K910628ALL BOND LINER-F2Cleared 510(K)
- K905302DENTHESIVE2Cleared 510(K)
- K904724CONQUEST DIRECT FILLING COMPOSITE (DFC)2Cleared 510(K)
- K904289PERTAC UNIVERSAL BOND2Cleared 510(K)
- K902744DEGUFILL (TM) BOND2Cleared 510(K)
- K901871DEGUFILL (R) ADHESIVE2Cleared 510(K)
- K901870DEGUFILL (R) BOND2Cleared 510(K)
- K901913SYNTAC (DENTIN BONDING AGENT)2Cleared 510(K)
- K897009PALFIQUE LIGHT BONDING AGENT2Cleared 510(K)
- K900558PERTAC BOND2Cleared 510(K)
- K897020ALL-BOND DENTIN BONDING SYSTEM2Cleared 510(K)
- K896659SILANE2Cleared 510(K)
- K8966559.6% HYDROFLUORIC ACID GEL2Cleared 510(K)
- K896382MODIFIED GLUMA BONDING SYSTEM2Cleared 510(K)
- K895750HEMA-PRIMER2Cleared 510(K)
- K894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT2Cleared 510(K)
- K894994DENTIN BONDING SYSTEM2Cleared 510(K)
- K894391PVS DUAL CURE VENEER BONDING KIT2Cleared 510(K)
- K892003ABRAKADABRA - DENTAL ADHESIVE SYSTEM2Cleared 510(K)
- K891455DENTIN PRIMER2Cleared 510(K)
- K884533SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM2Cleared 510(K)
- K885010TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING2Cleared 510(K)
- K884918PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER2Cleared 510(K)
- K884752KETAC-GLAZE2Cleared 510(K)
- K884137MIRAGE BOND2Cleared 510(K)
- K880684XR PRIMER2Cleared 510(K)
- K874074TEMPORARY DISCLOSING SOLUTION2Cleared 510(K)
- K872959CLEARFIL PHOTO BOND2Cleared 510(K)
- K871636CLEARFIL PORCELAIN BOND2Cleared 510(K)
- K863522MODIFIED SELF-CURE BONDING AGENT2Cleared 510(K)
- K862829PANAGRAF2Cleared 510(K)
- K860971DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER)2Cleared 510(K)
- K860346KERR PORCELITE2Cleared 510(K)
- K852660ETCH AND BOND2Cleared 510(K)
- K851056OPAQUER/BONDING AGENT2Cleared 510(K)
- K843025COMMAND ENAMEL-DENT DENTAL ADHESIVE2Cleared 510(K)
- K843023KERR PORCELAIN REPAIR PRIMER2Cleared 510(K)
- K842078JOHNSON & JOHNSON FLAVORED ETCHING GEL2Cleared 510(K)
- K840726RESTODENT DENTIN BONDING AGENT2Cleared 510(K)
- K841458NUMBER 20 R/L SYSTEM2Cleared 510(K)
- K841457NUMBER 21 R/R SYSTEM2Cleared 510(K)
- K833718ETCHING GEL2Cleared 510(K)
- K833473DENTIN BONDING AGENT2Cleared 510(K)
- K830387MICRODAPT DENTAL RESTORATIVE BONDING2Cleared 510(K)
- K822451AURAFILL* DENTAL RESTORATIVE BONDING AG.2Cleared 510(K)
- K813180SCOTCHBOND DENTAL ADHESIVE2Cleared 510(K)
- K812117PERMAGUM ADHESIVE2Cleared 510(K)
- K812116PERMAGUM2Cleared 510(K)
- K810407HYDROXYLATE ENAMEL BOND SYSTEM2Cleared 510(K)
- K810265VISIO-BAND2Cleared 510(K)
- K802681HELIOBOND2Cleared 510(K)
- K802333INSTANT BRIDGE2Cleared 510(K)
- K801216DEN-MAT DENTIN BONDING AGENT2Cleared 510(K)
- K801093PRISMA-BOND2Cleared 510(K)
- K800389ANTERIOR & POST. RESTORATIVE PASTE SYS.2Cleared 510(K)
- K800390ANT. & POST. RESTORATIVE POWDER LIQ.2Cleared 510(K)
- K790833VISIO-BOND2Cleared 510(K)
- K782080VENEER SYSTEM, MOSTIQUE LAMINATE2Cleared 510(K)
- K771328UVIOBOND2Cleared 510(K)
- K771326NIMETIC BONDING MATERIAL2Cleared 510(K)
- K771325NIMETIC ETCHING GEL2Cleared 510(K)
- K760400BONDING AGENT, VYTOL2Cleared 510(K)
- K760324BONDING AGENT, PRESTIGE2Cleared 510(K)
- 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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HC Primer
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K161891
- 510(k) Type
- Traditional
- Applicant
- Shofu Dental Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/21/2016
- Days to Decision
- 133 days
- Submission Type
- Statement