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
- K052463PROMETAL HN862Cleared 510(K)
- K041378BIO 602Cleared 510(K)
- K040672PORTA REFLEX2Cleared 510(K)
- K040524PORTA SOLDER 1090 W2Cleared 510(K)
- K040043NDX-40 ALLOY2Cleared 510(K)
- K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM2Cleared 510(K)
- K033279GOLD DENTAL CASTING ALLOYS2Cleared 510(K)
- K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 822Cleared 510(K)
- K033435E-SARANG 86, DM78, DM552Cleared 510(K)
- K032320APPOLLO 3 ALLOY2Cleared 510(K)
- K032317ORION GX ALLOY2Cleared 510(K)
- K032316ORION E ALLOY2Cleared 510(K)
- K032321CERA F ALLOY2Cleared 510(K)
- K032319CERA R PLUS ALLOY2Cleared 510(K)
- K032318MINERVA 58 ALLOY2Cleared 510(K)
- K032851ULTRACROWN 75 ALLOY2Cleared 510(K)
- K032715DW 296 #15 SOLDER2Cleared 510(K)
- K032267R&D DESIGNATION AP-052-52Cleared 510(K)
- K032493ALEXANDER2Cleared 510(K)
- K032106STARBOND DENTAL BONDING ALLOYS2Cleared 510(K)
- K031010MIRACLE 982Cleared 510(K)
- K031264PORTA PRESSOVER2Cleared 510(K)
- K031543STARCAST DENTAL ALLOYS2Cleared 510(K)
- K030436BIO UNIVERSAL2Cleared 510(K)
- K030435BIOUNIVERSAL PKF2Cleared 510(K)
- K030312PORTA IMPLANT2Cleared 510(K)
- K024135AIGIS-PLUS2Cleared 510(K)
- K024143AIGIS-FINE2Cleared 510(K)
- K024142AIGIS-SUPER2Cleared 510(K)
- K024136AIGIS-SOFT2Cleared 510(K)
- K024145AIGIS-XO2Cleared 510(K)
- K024144AIGIS-PT2Cleared 510(K)
- K024139AIGIS-INLAY2Cleared 510(K)
- K024141NEO 762Cleared 510(K)
- K024140AIGIS-A2Cleared 510(K)
- K030206APEX 902Cleared 510(K)
- K023831UCP DENTAL MATERIAL2Cleared 510(K)
- K023790UCC DENTAL MATERIAL2Cleared 510(K)
- K023501GOLD CORE 352Cleared 510(K)
- K023395PORTADUR P22Cleared 510(K)
- K023391BIOPORTA G2Cleared 510(K)
- K023392AGC SPECIAL ALLOY2Cleared 510(K)
- K023389PORTA GEO TI2Cleared 510(K)
- K023197CERANUM 822Cleared 510(K)
- K023199CERANUM 502Cleared 510(K)
- K023200CERANUM 762Cleared 510(K)
- K023198CERANUM 902Cleared 510(K)
- K023196LUCIUS 762Cleared 510(K)
- K022663KERADEC2Cleared 510(K)
- K022969UNIVERSAL CERAMIC SOLDER2Cleared 510(K)
- K022811W-52Cleared 510(K)
- K022470PORTA SOLDER 1080 W2Cleared 510(K)
- K022462BIOPORTA SOLDER 10202Cleared 510(K)
- K022457PORTA OPTIMUM SOLDER 7102Cleared 510(K)
- K022468PORTA OPTIMUM SOLDER 9002Cleared 510(K)
- K022467PORTA IP SOLDER V-22Cleared 510(K)
- K022456PORTA IP SOLDER V-12Cleared 510(K)
- K022459AUROPAL SOLDER M-12Cleared 510(K)
- K022454PORTA OP SOLDER W-22Cleared 510(K)
- K022452PORTA OP SOLDER M-12Cleared 510(K)
- K022451AUROPAL SOLDER W-22Cleared 510(K)
- K021948LUCIUS 622Cleared 510(K)
- K022206JENSEN GOLD FOIL2Cleared 510(K)
- K021947CERANUM 872Cleared 510(K)
- K021926AUROPAL 602Cleared 510(K)
- K021892BRIGHT GOLD2Cleared 510(K)
- K021733AUTOPAL 502Cleared 510(K)
- K021741CRITERTION, MODEL #10675112Cleared 510(K)
- K021242PORTALLOY 542Cleared 510(K)
- K020347AGC SPEZIALLEGIERUNG2Cleared 510(K)
- K020949APOLLO, MODEL 11245252Cleared 510(K)
- K020190PORTADUR P 42Cleared 510(K)
- K013769V-GNATHOS SUPRA2Cleared 510(K)
- K013506YELLOW SPECIAL2Cleared 510(K)
- K012839AUROPAL, ORDER-NO.: 21012Cleared 510(K)
- K013505AUROFLUID PLUS2Cleared 510(K)
- K012877HIGH GOLD PALLADIUM FREE CERAMIC SOLDER2Cleared 510(K)
- K012843PORTADUR P 2, MODEL #20312Cleared 510(K)
- K012834PORTA GEO TI MODEL #20042Cleared 510(K)
- K012826BIOPORTA G, MODEL 20522Cleared 510(K)
- K012827PORTA AURIUM, MODEL 20672Cleared 510(K)
- K012831BIO PORTADUR, ORDER-NO.:20172Cleared 510(K)
- K012835PORTA MAXIMUM, MODEL# 20662Cleared 510(K)
- K012838ERO50, ORDER-NO.: 20702Cleared 510(K)
- K011661CONCORD 882Cleared 510(K)
- K011659GPW-SF2Cleared 510(K)
- K011628CONCORD 822Cleared 510(K)
- K011626CONCORD 722Cleared 510(K)
- K011330JP CAST 502Cleared 510(K)
- K011331JP CAST 402Cleared 510(K)
- K011362GOLD CORE 73 LS2Cleared 510(K)
- K011036RD-30082Cleared 510(K)
- K011023D.SIGN 962Cleared 510(K)
- K011022BIOUNIVERSAL PDF2Cleared 510(K)
- K010611R & D DESIGNATION AP-0472Cleared 510(K)
- K010414R & D DESIGNATION AP-0352Cleared 510(K)
- K010416HERACERAM 752Cleared 510(K)
- K010044COSMIC2Cleared 510(K)
- K003603BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE2Cleared 510(K)
- K003635DW 276 #32Cleared 510(K)
- K003634DW 272 #12Cleared 510(K)
- K003633DW 277 #42Cleared 510(K)
- K002854GOLD CORE POST SOLDER2Cleared 510(K)
- K002815GOLD CORE HF PRE SOLDER2Cleared 510(K)
- K003007GALAXY2Cleared 510(K)
- K002872R&D PROJECT DW271#11A2Cleared 510(K)
- K002675MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM2Cleared 510(K)
- K002826EQUITY2Cleared 510(K)
- K002645JEL BIOS PURE2Cleared 510(K)
- K002222RD-21042Cleared 510(K)
- K001482AURENORM 75 KF2Cleared 510(K)
- K001481PALCERAM 492Cleared 510(K)
- K001480AURECAST 40 B2Cleared 510(K)
- K001479PALCERAM 532Cleared 510(K)
- K001477AURELUX Y 84 PREMIUM2Cleared 510(K)
- K001478AURECAST SUPER INLAY2Cleared 510(K)
- K001041AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD2Cleared 510(K)
- K001260ALLROUND 55 LF2Cleared 510(K)
- K001196JEL BIOS 90 (CODE NAME RD-2401)2Cleared 510(K)
- K001051RX EVEREST2Cleared 510(K)
- K000360RX G-UNIVERSAL2Cleared 510(K)
- K993508V-SUPRA PLUS, ALLOY NO. 50252Cleared 510(K)
- K993507V-SUPRAGOLD, ALLOY NO. 50242Cleared 510(K)
- K993173GOLD CORE 552Cleared 510(K)
- K993175GOLD CORE 752Cleared 510(K)
- K993152JEL BIOS 18 (CODE NAME RD- 1214)2Cleared 510(K)
- K993136JEL BIOS 10 (CODE NAME RD-1801)2Cleared 510(K)
- K991901BIO-972Cleared 510(K)
- K990670HELIOFORM GOLD-BASED ALLOY2Cleared 510(K)
- K984140MAINBOND A2Cleared 510(K)
- K983080AUROLLOYD KF2Cleared 510(K)
- K983082BEGOCER G2Cleared 510(K)
- K983077BIO PONTOSTAR2Cleared 510(K)
- K983079PLATINLLOYD 1002Cleared 510(K)
- K982606AUROFLUID CPF2Cleared 510(K)
- K981244BW-1 (CODE NAME RD-0807)2Cleared 510(K)
- K980660BIOGOLD PLUS DENTAL ALLOY2Cleared 510(K)
- K980613PROGOLD ELECTROCOPING SYSTEM2Cleared 510(K)
- K980597CARRARA PDF, CARRARA H, CARRARA R2Cleared 510(K)
- K972946AURELUX 772Cleared 510(K)
- K973372AUROFILM 20002Cleared 510(K)
- K973881PROSPECTOR PLUS (CODE NAME : RD-0508)2Cleared 510(K)
- K972910PORS ON LITE2Cleared 510(K)
- K972949AURELUX BIO Y85PF2Cleared 510(K)
- K972943AURECAST 922Cleared 510(K)
- K972950HIPALLAUR 192Cleared 510(K)
- K972951HIPALLAUR 512Cleared 510(K)
- K972952AUREBOND 512Cleared 510(K)
- K972953PALAUREX 76KF2Cleared 510(K)
- K972954PALAUREX 782Cleared 510(K)
- K972955PALCERAM 562Cleared 510(K)
- K972956PALCERAM 82SF2Cleared 510(K)
- K972941AURECAST 742Cleared 510(K)
- K972942AURECAST 832Cleared 510(K)
- K972319AURECAST GF2Cleared 510(K)
- K972939AURECAST BIO 59PF2Cleared 510(K)
- K972940AURECAST BIO 69PF2Cleared 510(K)
- K972936AURECAST 22Cleared 510(K)
- K972938AURECAST 102Cleared 510(K)
- K972937AURECAST 42Cleared 510(K)
- K972632VERA PD SOLDER2Cleared 510(K)
- K972532AALBA GOLD SOLDER2Cleared 510(K)
- K971575BENCHMARK-IV2Cleared 510(K)
- K971574JELBOND-PDF2Cleared 510(K)
- K971292JEL-71 PDF2Cleared 510(K)
- K970963TARGIS ALLOY #72Cleared 510(K)
- K970068JELENKO NO.1 (CODE NAME RD-0601)2Cleared 510(K)
- K964772AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)2Cleared 510(K)
- K964950LA PLATA 28 (PM-28)2Cleared 510(K)
- K964949AURORA 532Cleared 510(K)
- K964948AURORA 52 (PM-01)2Cleared 510(K)
- K964941EL DORADO 402Cleared 510(K)
- K964940TAOS 282Cleared 510(K)
- K964838PALLADIA 85 (PM-13)2Cleared 510(K)
- K964788EL DORADO 552Cleared 510(K)
- K964789LA PLATA 392Cleared 510(K)
- K964792LA PLATA 402Cleared 510(K)
- K964837PACIFIC 56 (CB-40)2Cleared 510(K)
- K964708SOLDER 6152Cleared 510(K)
- K964158JEL-40 (CODE NAME RD-0430)2Cleared 510(K)
- K964567EL DORADO 752Cleared 510(K)
- K964573PIEDMONT 70 (CH-35)2Cleared 510(K)
- K964572PALLADIA 762Cleared 510(K)
- K964569EL DORADO 582Cleared 510(K)
- K964568OZARK 462Cleared 510(K)
- K964566OZARK 202Cleared 510(K)
- K964476DE ORO 772Cleared 510(K)
- K964477OZARK 402Cleared 510(K)
- K964465LA PLATA 34 (PM-25)2Cleared 510(K)
- K964478OSAGE 762Cleared 510(K)
- K964464PACIFIC 52 (CB-39)2Cleared 510(K)
- K964466PALLADIA 75 (PM-11)2Cleared 510(K)
- K962326STERNGOLD BIO-5 (1127210)2Cleared 510(K)
- K962325QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)2Cleared 510(K)
- K962303STERNGOLD CF2Cleared 510(K)
- K962302PEGASUS DENTAL ALLOY2Cleared 510(K)
- K960956STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 11272002Cleared 510(K)
- K961352285 SL2Cleared 510(K)
- K961211ARGELITE 52+2Cleared 510(K)
- K961285ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)2Cleared 510(K)
- K960403DIAMOND (CODE NAME PT-054)2Cleared 510(K)
- K960399TOPAZ2Cleared 510(K)
- K960256DEGUDENT LS2Cleared 510(K)
- K960226DG 882Cleared 510(K)
- K960104BIOCCLUS 42Cleared 510(K)
- K955509MIDAS GOLD ELECTROFORMING SYSTEM2Cleared 510(K)
- K955118DEGUBOND X-LITE PLUS2Cleared 510(K)
- K955027DEGUBOND X-LITE2Cleared 510(K)
- K954837DW260 192Cleared 510(K)
- K954702IMPLANTALOY2Cleared 510(K)
- K954362ARGISTAR 742Cleared 510(K)
- K954404AUROLITE 452Cleared 510(K)
- K954371SUREFIRE S2Cleared 510(K)
- K954359SILFREE 80SF+2Cleared 510(K)
- K954361ARGENCO 68M2Cleared 510(K)
- K954360ARGESOL 6002Cleared 510(K)
- K954358ARGENDENT GIO 86 FR2Cleared 510(K)
- K954367ARGISTAR BIO 75PF2Cleared 510(K)
- K954368ARGEDENT BIO 87 PF2Cleared 510(K)
- K953344DEGUBOND ULTRA2Cleared 510(K)
- K951271VS11 SF2Cleared 510(K)
- K952403AUROLITE 802Cleared 510(K)
- K952499VS1 PLUS2Cleared 510(K)
- K952402AURIUM 68M2Cleared 510(K)
- K951789PALLIAG NF IV2Cleared 510(K)
- K951786DEGULOR A2Cleared 510(K)
- K951788DEGULOR S2Cleared 510(K)
- K951791DEPALOR2Cleared 510(K)
- K951790PONTALLOR 32Cleared 510(K)
- K951787DEGUBOND 42Cleared 510(K)
- K952122V-GNATHOS PLUS2Cleared 510(K)
- K951785PRIMALLOR 22Cleared 510(K)
- K951784PRIMALLOR 12Cleared 510(K)
- K951783BOND-ON 42Cleared 510(K)
- K951781PORS ON PLUS2Cleared 510(K)
- K951779DEGULOR M2Cleared 510(K)
- K951782STABILOR G2Cleared 510(K)
- K951780STABILOR NF IV2Cleared 510(K)
- K951777DEGUSTAR GA-22Cleared 510(K)
- K951778DEGUDENT U2Cleared 510(K)
- K951298MAXIGOLD KF2Cleared 510(K)
- K951297HARMONY LINE KF2Cleared 510(K)
- K950187FUTURA ONE2Cleared 510(K)
- K950517HARMONY LINE PF2Cleared 510(K)
- K950858AUROLITE 552Cleared 510(K)
- K950772ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)2Cleared 510(K)
- K950310ENDURE2Cleared 510(K)
- K945910QUEST 2 AND 202Cleared 510(K)
- K945723OPULENT 76 AND 832Cleared 510(K)
- K945401WHITE STAR2Cleared 510(K)
- K944889ALLROUND 42Cleared 510(K)
- K944888MEDALIST2Cleared 510(K)
- K944887EUREKA PLUS2Cleared 510(K)
- K944679JEL 962Cleared 510(K)
- K944557DW250 #912Cleared 510(K)
- K944572V-DELTA N (V-DELTA LOY), AUROFLUID 2PF2Cleared 510(K)
- K926378THERMABOND V2Cleared 510(K)
- K943757SOLDER AUROLITE REPAIR2Cleared 510(K)
- K943755SOLDER AUROLITE CB2Cleared 510(K)
- K943838ARGESOL #7602Cleared 510(K)
- K943779ARGESOL #7202Cleared 510(K)
- K943487BIO74-PF CROWN & BRIDGE ALLOY2Cleared 510(K)
- K943266SOLDER #2102Cleared 510(K)
- K943271SOLDER #2062Cleared 510(K)
- K943269SOLDER #2092Cleared 510(K)
- K943267SOLDER #2112Cleared 510(K)
- K943264SOLDER #2052Cleared 510(K)
- K943209ARGESOL PNP2Cleared 510(K)
- K943214SOLDER #2042Cleared 510(K)
- K943213ARGIPLUS LO2Cleared 510(K)
- K943212ARGESOL #830Y2Cleared 510(K)
- K943211ARGESOL 750Y2Cleared 510(K)
- K943210ARGESOL #1005Y2Cleared 510(K)
- K943208ARGESOL 750PY2Cleared 510(K)
- K943089ARGESOL 830W2Cleared 510(K)
- K943088ARGESOL R2Cleared 510(K)
- K943087ARGESOL 750W2Cleared 510(K)
- K943032AURIUM Y+2Cleared 510(K)
- K943037ARGEDENT 412Cleared 510(K)
- K942943ARGESOL-NOVASOL2Cleared 510(K)
- K942929ARGESOL LO2Cleared 510(K)
- K942980ARGESOL #6152Cleared 510(K)
- K942979ARGESOL-ARGICRAFT-12Cleared 510(K)
- K942978ARGESOL #6502Cleared 510(K)
- K942981ARGESOL #5852Cleared 510(K)
- K942928ARGESOL 5002Cleared 510(K)
- K942859ARGESOL-YPF2Cleared 510(K)
- K942589ARGESOL P2Cleared 510(K)
- K942595ARGELITE PF+2Cleared 510(K)
- K942590ARGESOL W2Cleared 510(K)
- K942557ARGESOL-1060W2Cleared 510(K)
- K942539ARGESOL-LITE2Cleared 510(K)
- K942540ARGESOL-WG2Cleared 510(K)
- K942538ARGESOL-1040Y2Cleared 510(K)
- K942507ARGESOL-Y2Cleared 510(K)
- K942505ARGESOL-WSF PRE-SOLDER FOR HIGH GOLD DENTAL PROCELAIN ALLOYS2Cleared 510(K)
- K942462ARGESOL-YSF PRE-SOLDER FOR HI GOLD DENT PORCEL ALLOYS2Cleared 510(K)
- K941072AURIUM PC162Cleared 510(K)
- K941067AUROLITE CB2Cleared 510(K)
- K941097AURIUM D162Cleared 510(K)
- K941068AUROLITE CB802Cleared 510(K)
- K941071AUROLITE CB252Cleared 510(K)
- K941070AUROLITE CB+22Cleared 510(K)
- K941069AUROLITE MT12Cleared 510(K)
- K932243GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO2Cleared 510(K)
- K940930AURIUM G142Cleared 510(K)
- K941003AURIUM 20% (LOW GOLD CROWN AND BRIDGE ALLOY)2Cleared 510(K)
- K941002AURIUM X6 (MEDIUM GOLD CROWN AND BRIDGE ALLOY)2Cleared 510(K)
- K940929AURIUM 50Y2Cleared 510(K)
- K940865AURIUM D17 (HIGH GOLD CROWN & BRIDGE ALLOY)2Cleared 510(K)
- K940856AURIUM G13 (HIGH GOLD CROWN AND BRIDGE ALLOY)2Cleared 510(K)
- K940789AURIUM C2Cleared 510(K)
- K940855AURIUM SG (HIGH GOLD CROWN AND BRIDGE ALLOY)2Cleared 510(K)
- K940779AURIUM D42Cleared 510(K)
- K940788AURIUM 8302Cleared 510(K)
- K940787AURIUM B42Cleared 510(K)
- K940761AURIUM 22KT2Cleared 510(K)
- K940747SILFREE 792Cleared 510(K)
- K940719SILFREE2Cleared 510(K)
- K940617SUREFIRE 122Cleared 510(K)
- K940619SILFREE 79+2Cleared 510(K)
- K940618AUROLITE 412Cleared 510(K)
- K940610AUROLITE 92Cleared 510(K)
- K940580AUROLITE 62Cleared 510(K)
- K940579AURIUM 2392Cleared 510(K)
- K940485AUROLITE 2A2Cleared 510(K)
- K940435AUROLITE 54+22Cleared 510(K)
- K940434AUROLITE 2B2Cleared 510(K)
- K940361AUROLITE 1C2Cleared 510(K)
- K926177DW246 #432Cleared 510(K)
- K940360AUROLITE 852Cleared 510(K)
- K940343AUROLITE 1B2Cleared 510(K)
- K940342SUREFIRE W2Cleared 510(K)
- K940341AUROLITE 1K2Cleared 510(K)
- K940337SILFREE 2 HIGH-PALLADIUM ALLOY FOR PORCELAIN APPLICATION2Cleared 510(K)
- K940282SUREFIRE 102Cleared 510(K)
- K940281ARGEDENT 51SF2Cleared 510(K)
- K940280SUREFIRE A2Cleared 510(K)
- K940278AURIUM J2Cleared 510(K)
- K940111AURIUM 2242Cleared 510(K)
- K933623EUREKA2Cleared 510(K)
- K935973ARGISTAR 72 (HIGH GOLD PLATINUM SILVER ALLOY FOR BOTH LOW FUSING PORCELAIN AND CROWN AND BRIDGE APPLICATION2Cleared 510(K)
- K935508ARGEDENT 78PF2Cleared 510(K)
- K935507ARGEDENT 77PF2Cleared 510(K)
- K915612ARGENCO Y +2Cleared 510(K)
- K935387PONTOR LFC2Cleared 510(K)
- K931556ARGENCO M2Cleared 510(K)
- K934769ARGELITE W2Cleared 510(K)
- K932774DW232 #312Cleared 510(K)
- K933178GDC 35092Cleared 510(K)
- K933186DW 248 #462Cleared 510(K)
- K933083DW247 #22Cleared 510(K)
- K931554ARGELITE 852Cleared 510(K)
- K932130FREEDOM PLUS (CODE NAME MISC-LIB-013)2Cleared 510(K)
- K931475ARGELITE 552Cleared 510(K)
- K931365DW207 #28G, DW207 #35F, DW207 #39LC2Cleared 510(K)
- K931089VGA-50 GOLD ALLOY2Cleared 510(K)
- K931090PALLADIUS-6 ALLOY SEMI-PRECIOUS ALLOY2Cleared 510(K)
- K930762SUPERSTAR2Cleared 510(K)
- K930601FREEDOM2Cleared 510(K)
- K930481DENTAL CASTING ALLOY MODIFICATION-PF-42Cleared 510(K)
- K930482DENTAL CASTING ALLOY, MODIFICATION - PF-32Cleared 510(K)
- K925974CASTING GOLD,CERAMIC,GOLD WIRE,ALLOY PRECISION ATT2Cleared 510(K)
- K925973VS1 GPF, VACU PF2Cleared 510(K)
- K923714SYMPHONY2Cleared 510(K)
- K923817ULTRAGOLD2Cleared 510(K)
- K923716JEL-0-752Cleared 510(K)
- K923722HN-402Cleared 510(K)
- K923721PROSPECTOR2Cleared 510(K)
- K923720SUNCAST2Cleared 510(K)
- K923719SUNCAST D-KF2Cleared 510(K)
- K923718HP-32Cleared 510(K)
- K923715SUNCAST-D2Cleared 510(K)
- K923713MICROSTAR2Cleared 510(K)
- K922774COLLEGIATE2Cleared 510(K)
- K924241ARGENCO 75M2Cleared 510(K)
- K921772BIOLOR2Cleared 510(K)
- K921794CERADELTA 22Cleared 510(K)
- K915507E-Z GOLD TOOTH FILLING MATERIAL2Cleared 510(K)
- K920060DENTAL SOLDER ALLOY2Cleared 510(K)
- K920244DW240 #73C ALLOY FOR PORCELAIN FUSED TO METAL2Cleared 510(K)
- K915626EZ GOLD2Cleared 510(K)
- K915111PONTOR MPF,V-GNATHOS PF,24K CASTING GOLD2Cleared 510(K)
- K914186ULTRACROWN(TM) PRE-SOLDER2Cleared 510(K)
- K912721AUROFILM MP2Cleared 510(K)
- K912313SOLCHROM-PAL2Cleared 510(K)
- K912297VS1G2Cleared 510(K)
- K911546INLAY 902Cleared 510(K)
- K911042GAMMAT ELECTROFORMED GOLD COPING2Cleared 510(K)
- K911531V-SUPERGOLD2Cleared 510(K)
- K911544SOLARO 42Cleared 510(K)
- K911543SOLARO 32Cleared 510(K)
- K911542PONTOR 22Cleared 510(K)
- K911541PONTOR 4 CF2Cleared 510(K)
- K911540PROTH-AURO 222Cleared 510(K)
- K911539AUROFLUID 32Cleared 510(K)
- K911538AUROFLUID 22Cleared 510(K)
- K911537V-DELTA, SF2Cleared 510(K)
- K911536V-DELTABOND2Cleared 510(K)
- K911535V-CLASSIC2Cleared 510(K)
- K911534V442Cleared 510(K)
- K911533V922Cleared 510(K)
- K911532V-SUPER2Cleared 510(K)
- K911530V-GNATHOS2Cleared 510(K)
- K910065GDC-3200 DENTAL SOLDER2Cleared 510(K)
- K905329WILL-CERAM W2Cleared 510(K)
- K905327MAXIGOLD2Cleared 510(K)
- K905320WLW2Cleared 510(K)
- K905811ARGENCO 52HN2Cleared 510(K)
- K905761TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.2Cleared 510(K)
- K905322MIDIGOLD 502Cleared 510(K)
- K905387DEGUDENT GS2Cleared 510(K)
- K905319VARIOUS2Cleared 510(K)
- K904695GDC-15012Cleared 510(K)
- K905197THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM2Cleared 510(K)
- K905326MINIGOLD2Cleared 510(K)
- K905323WILL-CERAM Y AND WILL -CERAM Y-12Cleared 510(K)
- K905324WILL-CERAM W-12Cleared 510(K)
- K905330HARMONY LINE ALLOYS2Cleared 510(K)
- K905325X-L AND X-LX2Cleared 510(K)
- K904614GDC-14752Cleared 510(K)
- K904437ARGENCO 192Cleared 510(K)
- K904343ARGENCO 222Cleared 510(K)
- K903537250 SL DENTAL CASTING ALLOY2Cleared 510(K)
- K902863PALLADIUS-V AND PALLADIUS-AG SEMI-PRECIOUS ALLOY2Cleared 510(K)
- K895059HIGH FUSING YELLOW CERAMIC SOLDER2Cleared 510(K)
- K895058HIGH FUSING WHITE CERAMIC SOLDER2Cleared 510(K)
- K903678ARGENCO 8 GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903484SELECT 20, DENTAL ALLOY2Cleared 510(K)
- K903830NOVABOND GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903833DENTABOND GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903831ARGICRAFT 1 PALLADIUM SILVER ALLOY FOR PORCELAIN2Cleared 510(K)
- K903832ARGICRAFT 2 PALLADIUM SILVER ALLOY FOR PORCELAIN2Cleared 510(K)
- K903819ARGISTAR 45 GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903818ARGIBOND DENTAL ALLOY FOR PORCELAIN2Cleared 510(K)
- K903677ARGIDENT 2A DENTAL GOLD ALLOY FOR PORECLAIN2Cleared 510(K)
- K903549ARGENCO 252Cleared 510(K)
- K903548ARGENCO 92Cleared 510(K)
- K903680ARGIDENT YELLOW 3 GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903683ARGILITE 2 GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903682ARGILITE 1 GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903681ARGIDENT YELLOW 1 GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903685ARGIDENT K GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903684ARGIDENT 3 GOLD ALLOY FOR PORCELAIN2Cleared 510(K)
- K903679ARGIDENT YELLOW 2 GOLD ALLOY FOR PROCELAIN2Cleared 510(K)
- K903550TOPCAST2Cleared 510(K)
- K902898ARGENCO M-4 TYPE II DENTAL GOLD ALLOY2Cleared 510(K)
- K903282ARGENCO 122Cleared 510(K)
- K903283ARGENCO IV2Cleared 510(K)
- K903281ARGENCO 42Cleared 510(K)
- K903279ARGENCO 752Cleared 510(K)
- K903277ARGICAST B2Cleared 510(K)
- K903276ARGENCO 33 KF2Cleared 510(K)
- K903275ARGENCO 362Cleared 510(K)
- K903232ARGENCO 52Cleared 510(K)
- K903118ARGENCO 7A2Cleared 510(K)
- K903119ARGENCO 12Cleared 510(K)
- K903120ARGENCO 232Cleared 510(K)
- K903059ARGENCO 182Cleared 510(K)
- K902904ARGENCO 20 (20 CT) TYPE II DENTAL GOLD ALLOY2Cleared 510(K)
- K902899ARGENCO 10 TYPE I DENTAL GOLD ALLOY2Cleared 510(K)
- K902900ARGENCO M-1 TYPE II DENTAL GOLD ALLOY2Cleared 510(K)
- K902901ARGENCO 16 TYPE I DENTAL GOLD ALLOY2Cleared 510(K)
- K902903ARGENCO 17 TYPE II DENTAL GOLD ALLOY2Cleared 510(K)
- K902287RASTRONICS PORTAREM 202Cleared 510(K)
- K903278ARGENCO 282Cleared 510(K)
- K903274ARGENCO NORDIC2Cleared 510(K)
- K903280ARGENCO 272Cleared 510(K)
- K902966ARGENCO 2 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K902902ARGENCO 6 TYPE II DENTAL GOLD ALLOY2Cleared 510(K)
- K901530WALLACE INTRAUTERINE INSEMINATION CATHETER2Cleared 510(K)
- K902387DEGUSSA STOPFGOLD (DEGUSSA DIRECT-FILLING GOLD)2Cleared 510(K)
- K902373200 SILHOUETTE LINE (SL) CERAMIC SOLDER2Cleared 510(K)
- K902372SILVER-FREE CERAMIC SOLDER (SFCS)2Cleared 510(K)
- K901098SPARTAN PLUS2Cleared 510(K)
- K901533GDC 588 CASTING ALLOY2Cleared 510(K)
- K901532GDC 3084 CASTING ALLOY2Cleared 510(K)
- K896915PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL2Cleared 510(K)
- K895066MONOGRAM IV2Cleared 510(K)
- K896348ARGELITE 80 + 5 DENTAL ALLOY FOR PORCELAIN APPL.2Cleared 510(K)
- K893800SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL)2Cleared 510(K)
- K895070SELECT WHITE2Cleared 510(K)
- K895054.650 FINE GOLD SOLDER2Cleared 510(K)
- K895056LOW FUSING WHITE GOLD2Cleared 510(K)
- K895060750 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS2Cleared 510(K)
- K895063450 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS2Cleared 510(K)
- K895067SELECT 602Cleared 510(K)
- K895069SELECT 402Cleared 510(K)
- K895057HIGH FUSING WHITE GOLD2Cleared 510(K)
- K895068SELECT 502Cleared 510(K)
- K895065MONOGRAM III2Cleared 510(K)
- K895064MONOGRAM II2Cleared 510(K)
- K895062500 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS2Cleared 510(K)
- K895061700 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS2Cleared 510(K)
- K895055.730 FINE GOLD SOLDER2Cleared 510(K)
- K895053.615 FINE GOLD SOLDER2Cleared 510(K)
- K895052.585 FINE GOLD SOLDER2Cleared 510(K)
- K895051MONOGRAM I2Cleared 510(K)
- K895050100 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS2Cleared 510(K)
- K895049200 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS2Cleared 510(K)
- K895048300 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS2Cleared 510(K)
- K894924990 GOLD2Cleared 510(K)
- K893688HIGH NOBLE, TYPE III DENTAL CASTING ALLOY2Cleared 510(K)
- K893566ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY2Cleared 510(K)
- K893686ARGELOY N.P.2Cleared 510(K)
- K893565ARGENCO 68 TYPE IV DENTAL GOLD ALLOY2Cleared 510(K)
- K893568ARGENCO 56 TYPE IV DENTAL GOLD ALLOY2Cleared 510(K)
- K893563ARGENCO 42 TYPE IV DENTAL GOLD ALLOY2Cleared 510(K)
- K893567ARGENCO 52 TYPE IV DENTAL GOLD ALLOY2Cleared 510(K)
- K893564ARGENCO 30 TYPE IV DENTAL GOLD ALLOY2Cleared 510(K)
- K893554ARGENCO 60 TYPE IV DENTAL GOLD ALLOY2Cleared 510(K)
- K893442ARGENCO 58 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893443ARGENCO 60 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893441ARGENCO 50 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893444ARGENCO 46 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893434ARGENCO 20 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893413ARGENCO 40 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893383ARGENCO 75 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893386ARGENCO 62 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893385ARGENCO 77 TYPE II DENTAL GOLD ALLOY2Cleared 510(K)
- K893384ARGENCO 83 TYPE I DENTAL GOLD ALLOY2Cleared 510(K)
- K893382ARGENCO 63 TYPE III DENTAL GOLD ALLOY2Cleared 510(K)
- K893381ARGENCO 71 TYPE II DENTAL GOLD ALLOY2Cleared 510(K)
- K893345ARGELITE 50 (DENTAL ALLOY FOR PORCELAIN APPLI.)2Cleared 510(K)
- K892910ARGELITE 76SF+ DENTAL ALLOY2Cleared 510(K)
- K891600ARGEDENT 88, DENTAL ALLOY FOR PORCELAIN)2Cleared 510(K)
- K893227ARGENCO W+2Cleared 510(K)
- K892811ARGELITE 54B2Cleared 510(K)
- K893237ARGENCO W2Cleared 510(K)
- K892144MODIFIED ULTIMA LITE2Cleared 510(K)
- K893244ARGENCO WR+2Cleared 510(K)
- K893238ARGENCO WLF2Cleared 510(K)
- K893228ARGENCO W-LITE2Cleared 510(K)
- K893010ARGELITE 54+2Cleared 510(K)
- K892907CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR.2Cleared 510(K)
- K892810ARGEDENT 35SF2Cleared 510(K)
- K892709ARGEDENT 62 DENTAL ALLOY2Cleared 510(K)
- K892335ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI.2Cleared 510(K)
- K891989ARGEDENT 52 (DENTAL ALLOY)2Cleared 510(K)
- K893012ARGELITE 60+2Cleared 510(K)
- K892662ARGEDENT 872Cleared 510(K)
- K892909ARGELITE 80SF+ DENTAL ALLOY2Cleared 510(K)
- K892814ARGEDENT 452Cleared 510(K)
- K893008ARGELITE 542Cleared 510(K)
- K893009ARGELITE SR+2Cleared 510(K)
- K893011ARGIPAL2Cleared 510(K)
- K892908ARGELITE 80SF DENTAL ALLOY2Cleared 510(K)
- K892813ARGELITE 602Cleared 510(K)
- K892816ARGEDENT 382Cleared 510(K)
- K892812ARGELITE 75+62Cleared 510(K)
- K892815ARGEDENT 45SF2Cleared 510(K)
- K892708ARGEDENT Y-86 DENTAL ALLOY2Cleared 510(K)
- K891320ARGELITE 58P (DENTAL ALLOY)2Cleared 510(K)
- K892234ARGEDENT 752Cleared 510(K)
- K891911ARGEDENT 52SF2Cleared 510(K)
- K891530M-77 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891516C-89 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891535P-C PALLADIUM BASE DENTAL ALLOY2Cleared 510(K)
- K891534M-75 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891533M-74 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891532M-70 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891531M-50 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891529M-W SILVER PALLADIUM BASE DENTAL ALLOY2Cleared 510(K)
- K891528M-65 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891527M-60 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891525M-46 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891524M-40 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891523M-20 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891522M-4 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891521M-1 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891520C-87 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891519C-86 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891518C-76 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891517C-63 GOLD BAE DENTAL ALLOY2Cleared 510(K)
- K891514C-5 PALLADIUM BASE DENTAL ALLOY2Cleared 510(K)
- K891515C-52 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K891526M-56 GOLD BASE DENTAL ALLOY2Cleared 510(K)
- K890569NEYORO 65CF2Cleared 510(K)
- K890568ULTIMA LITE2Cleared 510(K)
- K885302GOLD/PALLADIUM BASED DENTAL ALLOY2Cleared 510(K)
- K882532STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS2Cleared 510(K)
- K883758ALBABOND 602Cleared 510(K)
- K883508HERA H2Cleared 510(K)
- K883036PALLIAG NF III2Cleared 510(K)
- K882126JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYS2Cleared 510(K)
- K881861PTM-452Cleared 510(K)
- K881860OLYMPIA II2Cleared 510(K)
- K880348PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI.2Cleared 510(K)
- K881354RAJAH2Cleared 510(K)
- K874308JEL-622Cleared 510(K)
- K880033DEGUSTAR2Cleared 510(K)
- K870677NEY-ORO 412Cleared 510(K)
- K870024PONTALLOR 4 DENTAL ALLOY2Cleared 510(K)
- K865049GDC 18242Cleared 510(K)
- K864306VERINOR ALLOY2Cleared 510(K)
- K853982GOLDEN CERAMIC2Cleared 510(K)
- K851872BLENGOLD SPECIAL2Cleared 510(K)
- K844867DUALLOR R SOLDER2Cleared 510(K)
- K844394RENAISSANCE BONDING AGENT2Cleared 510(K)
- K844395RENAISSANCE2Cleared 510(K)
- K833053Y CERAMIC2Cleared 510(K)
- K833052RXG2Cleared 510(K)
- K831098DOMINION2Cleared 510(K)
- K831280NEY-ORO 602Cleared 510(K)
- K823099RX MIDACAST2Cleared 510(K)
- K822956G CAST2Cleared 510(K)
- K822949RX SFC2Cleared 510(K)
- K821521STABILOR NF2Cleared 510(K)
- K821446DEGUDENT 142Cleared 510(K)
- K821613E.G. BRIDGE GOLD2Cleared 510(K)
- K820318SPECIAL WHITE2Cleared 510(K)
- K820277GDC-11302Cleared 510(K)
- K813417INZOMA P2Cleared 510(K)
- K810789GDC-10542Cleared 510(K)
- K792210GDC 802-DEVELOPMENT NAME2Cleared 510(K)
- K791304HOWMEDICA A-30 DENTAL ALLOY2Cleared 510(K)
- K79086614 KARAT CASTING GOLD2Cleared 510(K)
- K790414DEVELOPMENT NO. 6472Cleared 510(K)
- K790006GDC-5912Cleared 510(K)
- K781788GOLD, 24 KARAT CASTING2Cleared 510(K)
- K781169IMAGE2Cleared 510(K)
- K781045A-33 DENTAL ALLOY2Cleared 510(K)
- K771863COLOR COTE2Cleared 510(K)
- K771110HERITAGE SPECIAL ALLOY2Cleared 510(K)
- K770009BIOBOND C&B POST SOLDER2Cleared 510(K)
- K760797SPIRAFLO DIALYZER, DISPOSABLE2Cleared 510(K)
- K760122WILL-CERAM Y-22Cleared 510(K)
- 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
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- 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
JEL BIOS PURE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K002645
- 510(k) Type
- Traditional
- Applicant
- J.F. JELENKO & CO., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/19/2000
- Days to Decision
- 56 days
- Submission Type
- Statement