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
- 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
- EAQDetector, Ultraviolet2Product Code
- DYNMouthpiece, Saliva Ejector1Product Code
- EBRUnit, Suction Operatory1Product Code
- EBZActivator, Ultraviolet, For Polymerization2Product Code
- ECCSterilizer, Glass Bead3Product Code
- ECGSterilizer, Boiling Water1Product Code
- EEAPlate, Base, Shellac1Product Code
- EEFClamp, Rubber Dam1Product Code
- EEGHeat Source For Bleaching Teeth1Product Code
- EEJGuard, Disk1Product Code
- EFCWarmer, Anesthetic Tube1Product Code
- EFHPaper, Articulation1Product Code
- EFNCotton, Roll1Product Code
- EFSUnit, Oral Irrigation1Product Code
- EFWToothbrush, Manual1Product Code
- EFXProtector, Silicate1Product Code
- EGDWax, Dental, Intraoral1Product Code
- EHJDisk, Abrasive1Product Code
- EHKCup, Prophylaxis1Product Code
- EHLPoint, Abrasive1Product Code
- EHMStrip, Polishing Agent1Product Code
- EHYTray, Impression, Preformed1Product Code
- EHZEvacuator, Oral Cavity1Product Code
- EIAUnit, Operative Dental1Product Code
- EIEDam, Rubber1Product Code
- EIHPowder, Porcelain2Product Code
- K250393ZircaGlow & ZircaGlow HT Zirconia2Cleared 510(K)
- K250811Dental Zirconia Ceramic2Cleared 510(K)
- K250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )2Cleared 510(K)
- K250223BruxZir® Esthetic NOW2Cleared 510(K)
- K243940VITA YZ Multi Translucent2Cleared 510(K)
- K242740Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)2Cleared 510(K)
- K242521Estar-ZE2Cleared 510(K)
- K242407Dental Glass Ceramics Blocks (HT, LT, MT)2Cleared 510(K)
- K242462CEREC Cercon 4D CAD/CAM Blocks2Cleared 510(K)
- K242458ArgenZ MTZ2Cleared 510(K)
- K242400Dental porcelain powder2Cleared 510(K)
- K241151LUXEN 5G2Cleared 510(K)
- K233064Copra Supreme2Cleared 510(K)
- K241579DD Hybridlayer (multicolored zirconia)2Cleared 510(K)
- K241602Kingcera Dental Zirconia Blank2Cleared 510(K)
- K241557Cercon® yo ML2Cleared 510(K)
- K241715Dental Glass Ceramics Blocks (HT,LT,ST)2Cleared 510(K)
- K241316Zirconia Block2Cleared 510(K)
- K232952Copran Zri2Cleared 510(K)
- K233885rainbow Paste Stain SE2Cleared 510(K)
- K233158Copra Smile, Copra Supreme Hyperion2Cleared 510(K)
- K240672Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)2Cleared 510(K)
- K240912Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)2Cleared 510(K)
- K240772Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)2Cleared 510(K)
- K240882BruxZir® Esthetic2Cleared 510(K)
- K240419UltraThineer Zirconia Slurry (5Y-B)2Cleared 510(K)
- K240574BruxZir® Radiant2Cleared 510(K)
- K232682Pre-Sintered Zirconia Coloring Liquid2Cleared 510(K)
- K234014Obsidian® NOW2Cleared 510(K)
- K232174rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono2Cleared 510(K)
- K232676Dental Porcelain Powder2Cleared 510(K)
- K232673Dental Glass Ceramics2Cleared 510(K)
- K233125Zirconia Block2Cleared 510(K)
- K233016Dental Glass Ceramics2Cleared 510(K)
- K232438Dental Glass Ceramics Blocks2Cleared 510(K)
- K231687Gradual Dental Zirconia Blank2Cleared 510(K)
- K230487Dental Lithium Disilicate Glass-Ceramic2Cleared 510(K)
- K231264Easy On Universal Glaze & Stain2Cleared 510(K)
- K223029Perfit CL2Cleared 510(K)
- K231347BruxZir™ TintEFX Coloring Liquid2Cleared 510(K)
- K222961Harvest Conceal ZR Block Out2Cleared 510(K)
- K230259Soreal Press, Soreal CAD2Cleared 510(K)
- K230262BruxZir™ Incisal Coloring Liquid2Cleared 510(K)
- K230003Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank2Cleared 510(K)
- K223192XT Stain/Glaze2Cleared 510(K)
- K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)2Cleared 510(K)
- K223194Glass Ceramic2Cleared 510(K)
- K222513Glass Ceramics2Cleared 510(K)
- K213722ICE Ceramics, ICE Stains, Fresco2Cleared 510(K)
- K222626Dental Zirconia Ceramic2Cleared 510(K)
- K222520Zirconia Block2Cleared 510(K)
- K222686Perfit FS Dental Zirconia Fully Sintered Block2Cleared 510(K)
- K220369Esthetic Colorant2Cleared 510(K)
- K220816BruxZir NOW2Cleared 510(K)
- K221242Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank2Cleared 510(K)
- K221429KDF Zirconia Disc2Cleared 510(K)
- K221051Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank2Cleared 510(K)
- K220960BruxZir Opaque Coloring Liquid2Cleared 510(K)
- K220017Coloring Liquid2Cleared 510(K)
- K213147CERABIEN MiLai2Cleared 510(K)
- K212939Vintage Prime Press2Cleared 510(K)
- K214003Dental Zirconia Pre-shaded Block2Cleared 510(K)
- K214005Zirconia Dental Ceramics2Cleared 510(K)
- K213570Dental Zirconia Ceramic2Cleared 510(K)
- K212548LUXEN CL Dental Liquid2Cleared 510(K)
- K213425BruxZir Esthetic2Cleared 510(K)
- K212765Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank2Cleared 510(K)
- K212259Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank2Cleared 510(K)
- K211308INNI-CERA2Cleared 510(K)
- K202952Amber Mill Q Series & Amber Mill Direct Series2Cleared 510(K)
- K211916IPS e.max One2Cleared 510(K)
- K2108841Derful HS, 1Derful HT2Cleared 510(K)
- K210097Estar-Z2Cleared 510(K)
- K203672MAZIC Claro CAD and MAZIC Claro Press2Cleared 510(K)
- K203590Perfit FS Dental Zirconia Fully Sintered Block2Cleared 510(K)
- K203499Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank2Cleared 510(K)
- K201492Non-Sterile Zirconia Block2Cleared 510(K)
- K203351Perfit ZR HT Dental Zirconia blank2Cleared 510(K)
- K201915GenesisZr 4Y+ (ST1100) Zirconia2Cleared 510(K)
- K201608GenesisZr UHT700 Zirconia2Cleared 510(K)
- K202629Dentsply Sirona Universal Spray Glazes2Cleared 510(K)
- K202673X-cera Pre-shaded Zirconia Blanks2Cleared 510(K)
- K193090HCG Zirconia Ceramic Block2Cleared 510(K)
- K192723Coloring Liquid2Cleared 510(K)
- K193434VITA LUMEX AC2Cleared 510(K)
- K192231Dental Glass Ceramics Blocks2Cleared 510(K)
- K200131BruxZir Steel2Cleared 510(K)
- K192262Dental Zirconia Blocks2Cleared 510(K)
- K193436VITA Ambria2Cleared 510(K)
- K193055Purzir Dental Zirconia2Cleared 510(K)
- K193588DD Contrast2Cleared 510(K)
- K192535Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia2Cleared 510(K)
- K193060Noritake Super Porcelain EX-32Cleared 510(K)
- K192251Livento Press, Soprano 10, Soprano2Cleared 510(K)
- K190112Non-Sterile Zirconia Block2Cleared 510(K)
- K191903BruxZir GT (Gum Tissue) Color2Cleared 510(K)
- K190518Color Liquid, Vita Liquid2Cleared 510(K)
- K191304EthanZir Zirconia2Cleared 510(K)
- K191631ZMAXX Dental Zirconia Blanks2Cleared 510(K)
- K191902Razor, Everest, U&C Liquid2Cleared 510(K)
- K191794Vintage Art Universal2Cleared 510(K)
- K190569Shaders ZR2Cleared 510(K)
- K190436KATANA Zirconia Block2Cleared 510(K)
- K182350Dental Ceramic2Cleared 510(K)
- K190079ArgenZ HT+2Cleared 510(K)
- K183304Prettau, ICE, Z-White zirconia blanks2Cleared 510(K)
- K183408Jensen Shade Effect Liquids2Cleared 510(K)
- K183569DD cube ONE ML2Cleared 510(K)
- K182833ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer2Cleared 510(K)
- K182642GenesisZr™ 4Y Zirconia2Cleared 510(K)
- K181496VINTAGE PRO2Cleared 510(K)
- K182068Erran Dental Zirconia2Cleared 510(K)
- K181816Ceramic Denture Zirconia Ceramics Block2Cleared 510(K)
- K173971K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent2Cleared 510(K)
- K171585LUXEN Zr, LUXEN Smile2Cleared 510(K)
- K181167Upcera Glaze Paste, Glaze Powder, and Glaze Liquid2Cleared 510(K)
- K170050Z-CAD smile2Cleared 510(K)
- K180703VITA YZ ST and VITA YZ XT2Cleared 510(K)
- K180252Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank2Cleared 510(K)
- K173769DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid2Cleared 510(K)
- K171167Prodigio Stain Powder2Cleared 510(K)
- K161652DIAZIR2Cleared 510(K)
- K172761New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)2Cleared 510(K)
- K173410n!ce for Planmill2Cleared 510(K)
- K170834CERABIEN ZR2Cleared 510(K)
- K171876Ceramill Zolid HT+ white2Cleared 510(K)
- K163251Life Essence Universal Porcelain System2Cleared 510(K)
- K170885DD cubeX2 HS2Cleared 510(K)
- K170894Zirconia Dental Ceramics2Cleared 510(K)
- K170986KATANA Zirconia Block2Cleared 510(K)
- K163228APVolution System2Cleared 510(K)
- K163238Eclipse Kiss Zirconia2Cleared 510(K)
- K170420n!ce Glass Ceramic Blocks for Amann Girrbach2Cleared 510(K)
- K162888Cercon2Cleared 510(K)
- K161025priti multidisc ZrO2 High Translucent2Cleared 510(K)
- K161219Zmaxx T Series2Cleared 510(K)
- K162677L- OVC2Cleared 510(K)
- K160079rainbow Shine2Cleared 510(K)
- K160203ADAMANT ZIRCONIA DISC2Cleared 510(K)
- K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,2Cleared 510(K)
- K152023Luminesse Shaded Zirconia SZ2Cleared 510(K)
- K153130Initial LiSi Block2Cleared 510(K)
- K160867Pavati Z40.2 Zirconia2Cleared 510(K)
- K161922XP2022Cleared 510(K)
- K161269CELTRA Press2Cleared 510(K)
- K160367Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank2Cleared 510(K)
- K160144rainbow LS Block2Cleared 510(K)
- K160102Amber Mill Series and Amber Press Series2Cleared 510(K)
- K153136Initial LiSi Press2Cleared 510(K)
- K160099CEREC SpeedGlaze2Cleared 510(K)
- K152103IPS Style Ceram, IPS Style Ceram One, IPS Style Press2Cleared 510(K)
- K151731Rainbow Paste Stain2Cleared 510(K)
- K153767X-cera Zirconia Blanks2Cleared 510(K)
- K152274MSCB-0012Cleared 510(K)
- K152247ATLANTIS Crown2Cleared 510(K)
- K151846Rainbow LS Pressing2Cleared 510(K)
- K151842Rainbow Shine2Cleared 510(K)
- K152392VINTAGE LD2Cleared 510(K)
- K152118Zenostar MT, Zenostar Color Liquids2Cleared 510(K)
- K152451VINTAGE Art LF2Cleared 510(K)
- K152175Upcera Dental Zirconia Blank for Aesthetic Restoration2Cleared 510(K)
- K151894IPS Ivocolor2Cleared 510(K)
- K151875Pavati Zirconia2Cleared 510(K)
- K151723Rainbow Trans2Cleared 510(K)
- K152066Luminesse Anterior Zirconia AT2Cleared 510(K)
- K151844Rainbow Shade2Cleared 510(K)
- K151490PRETTAU ANTERIOR T02Cleared 510(K)
- K152383Ceramill Zolid FX2Cleared 510(K)
- K150919ArgenZ Esthetic Plus2Cleared 510(K)
- K143656StarCeram® Z-Nature, StarCeram® Z-Smile2Cleared 510(K)
- K150872BruxZir Anterior Milling Blanks2Cleared 510(K)
- K143071Nacera Pearl2Cleared 510(K)
- K140836ZIBONE ZIRCONIA BLOCKS2Cleared 510(K)
- K143090LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID2Cleared 510(K)
- K140491TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS2Cleared 510(K)
- K150056Luxisse+2Cleared 510(K)
- K150196DD cubeX22Cleared 510(K)
- K143439KATANA Zirconia2Cleared 510(K)
- K142987DD Bio Z, DD Bio ZX(square), DD BioZX(square) color2Cleared 510(K)
- K141400DCCERAM SYSTEM2Cleared 510(K)
- K142233zenostar MO, Zenostar T, Zenostar VisualiZr2Cleared 510(K)
- K142043INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA2Cleared 510(K)
- K141727DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES)2Cleared 510(K)
- K140848LUMINESSE PORCELAIN SYSTEM2Cleared 510(K)
- K143330BruxZir Anterior2Cleared 510(K)
- K141887OBSIDIAN PRESS (ALL CERAMIC AND POM)2Cleared 510(K)
- K132230ICE ZIRKON TRANSLUZENT2Cleared 510(K)
- K142670Vericore Zirconia Blanks2Cleared 510(K)
- K141724UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK2Cleared 510(K)
- K141723UPCERA COLORING LIQUID (I AND II )2Cleared 510(K)
- K141659PRISM ZIRCONIA, ST-982Cleared 510(K)
- K140877VERICORE ZIRCONIA BLANKS2Cleared 510(K)
- K141162ALL-CERAMIC ZIRCONIA BLOCK2Cleared 510(K)
- K141788OBSIDIAN MILLING BLOCKS2Cleared 510(K)
- K140924STARCERAM2Cleared 510(K)
- K140070LUXER SHADED ZIRCONIA2Cleared 510(K)
- K133211ZIRTOUGH2Cleared 510(K)
- K130991NEXXZR(TM)T AND NEXXZR(TM)S2Cleared 510(K)
- K132070VITA SUPRINITY(R)2Cleared 510(K)
- K133213STARCERAM2Cleared 510(K)
- K132102BECE CAD ZIRKON HT+2Cleared 510(K)
- K130198NEO DENTA ZIRCONIA2Cleared 510(K)
- K131534KATANA ZIRCONIA2Cleared 510(K)
- K130654CRYSTAL ULTRA2Cleared 510(K)
- K130604UNIVERSAL PASTE STAINS AND GLAZE2Cleared 510(K)
- K131117ZIRMON SERIES2Cleared 510(K)
- K130184ZENOLUX2Cleared 510(K)
- K130924BRUXZIR SHADED2Cleared 510(K)
- K122614VINTAGE MP PRESS OVER2Cleared 510(K)
- K123664INCORIS ZI2Cleared 510(K)
- K123952CEREC BLOCS C IN2Cleared 510(K)
- K123615IRIS - HIGH STRENGTH GLASS CERAMIC2Cleared 510(K)
- K123680COPRANCOLOR2Cleared 510(K)
- K123613SYNSPAR ADVANCED2Cleared 510(K)
- K123545INCORIS TZI2Cleared 510(K)
- K122269ENAMIC2Cleared 510(K)
- K122972CDC ZIRCONIA BLANKS2Cleared 510(K)
- K121980ZIRPRIME2Cleared 510(K)
- K121359IPS 99 ONE AND IPS 99 CERAM2Cleared 510(K)
- K120134IPS E.MAX PRESS MULTI2Cleared 510(K)
- K120852ZIRCONIA BLANKS (ZIRCOSTAR)2Cleared 510(K)
- K113431CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA2Cleared 510(K)
- K113575HILLA DIGITAL TRANSFERS2Cleared 510(K)
- K120011HEISENBERG EFFECT SHADES2Cleared 510(K)
- K112806JENSEN ZIRCONIA2Cleared 510(K)
- K112152CERCON HT2Cleared 510(K)
- K112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR2Cleared 510(K)
- K111743THE INSYNC CERAMIC SYSTEM2Cleared 510(K)
- K111573MONOBLOC BM SERIES2Cleared 510(K)
- K111383ZIRPRIME2Cleared 510(K)
- K110719ORIGIN ZIRCONIA2Cleared 510(K)
- K111291AIDITE ZIRCONIA DENTAL CERAMICS2Cleared 510(K)
- K111107SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE2Cleared 510(K)
- K111257HEISENBERG DYEING LIQUIDS2Cleared 510(K)
- K103556IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)2Cleared 510(K)
- K103773ZENOFLEX DIMENSION2Cleared 510(K)
- K103494ZENOSTAR MAGIC GLAZE2Cleared 510(K)
- K100794FLUORCANASITE DENTAL CERAMIC2Cleared 510(K)
- K102305HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P2Cleared 510(K)
- K102538ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI2Cleared 510(K)
- K101875BK BLANK MODEL 20,40,65,902Cleared 510(K)
- K100512NOBELPROCERA IPS E.MAX CROWN2Cleared 510(K)
- K102128VITABLOCS2Cleared 510(K)
- K100781OBSIDIAN CERAMIC BLOCKS2Cleared 510(K)
- K100150CERAMICS2IN12Cleared 510(K)
- K100232LUMINESSE ZR BLANKS2Cleared 510(K)
- K100145A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT062Cleared 510(K)
- K100250XCERAM2Cleared 510(K)
- K093571ZR DENTAL BLOCK2Cleared 510(K)
- K093559VINTAGE MP2Cleared 510(K)
- K093748DD BIO Z AND DD BIO Z - TRANSPA2Cleared 510(K)
- K093560UPCERA ZIRCONIA BLANKS2Cleared 510(K)
- K093446VITA VMK MASTER2Cleared 510(K)
- K092630ZIROX2Cleared 510(K)
- K092513RAINBOW BLOCK2Cleared 510(K)
- K092020AADVA ZR COLORING LIQUID2Cleared 510(K)
- K091826ELEGANT2Cleared 510(K)
- K090718BELLUS SHADING KIT2Cleared 510(K)
- K092496COPRAN ZR/ORIGIN YZ2Cleared 510(K)
- K091852BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R6102052Cleared 510(K)
- K091706QUATTRO PORCELAIN SYSTEM2Cleared 510(K)
- K090434BECE PRESS2Cleared 510(K)
- K091096NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B1002Cleared 510(K)
- K090684AVANTE LEUCITE BLOCKS2Cleared 510(K)
- K090644VITABLOCS, MODEL VX55-****2Cleared 510(K)
- K082137DLMS-ZIRBLOCKS2Cleared 510(K)
- K083201ZMATCH BLOCK2Cleared 510(K)
- K082652BITTAR ZIRCONIA BLOCKS2Cleared 510(K)
- K082740GC AADVA ZR DISK2Cleared 510(K)
- K082158DENSEO FAIRY2Cleared 510(K)
- K081749AVANTE Z ZIRCONIA (AS)3 BLOCKS2Cleared 510(K)
- K081850BISQUE ZIRCONIA BLANKS, TYPE BYZ2Cleared 510(K)
- K082257ZENO AI ECO DISC2Cleared 510(K)
- K081200DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T42Cleared 510(K)
- K081263STARCERAM2Cleared 510(K)
- K080834VINTAGE ART2Cleared 510(K)
- K080146ZIRKONDENT2Cleared 510(K)
- K080479DENTAL CERAMIC2Cleared 510(K)
- K081253ZIRDENT CAD/CAM BLOCKS2Cleared 510(K)
- K080195NACERA Z AND NACERA Z MEDIUM2Cleared 510(K)
- K073314HEANY INDUSTRIES INC DENTAL XIRCONIA2Cleared 510(K)
- K073568PSL BIOZIR BLOCK2Cleared 510(K)
- K073108ZENO ZR DISC2Cleared 510(K)
- K072569METOXIT CAM-BLANKS2Cleared 510(K)
- K071848IPS INLINE POM SYSTEM2Cleared 510(K)
- K071010TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS2Cleared 510(K)
- K071410ARGEN PEARL BRAND ZIRCONIA2Cleared 510(K)
- K071674GC-ZIRCONIA2Cleared 510(K)
- K071201ZEO CE LIGHT & ZEO QUICK PORCELAIN2Cleared 510(K)
- K070699AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN2Cleared 510(K)
- K070772PRESSX ZR2Cleared 510(K)
- K070537ZIRBLOCK2Cleared 510(K)
- K063842CYRTINA SYSTEM2Cleared 510(K)
- K070045ZIRBLANK-PS AND ZIRBLANK-FS2Cleared 510(K)
- K070114CREATION CP-ZI PORCELAIN2Cleared 510(K)
- K063511CERAMILL ZI2Cleared 510(K)
- K070019CARRARA VOLUMIA2Cleared 510(K)
- K062695SAGEMAX Z-BLANK2Cleared 510(K)
- K061804ZERION ALPHA, ; ZERION BETA2Cleared 510(K)
- K061851ZIRKONZAHN ICE2Cleared 510(K)
- K062509INCORIS ZI2Cleared 510(K)
- K062506INCORIS AL2Cleared 510(K)
- K062504CERAMAX2Cleared 510(K)
- K062389Z-BLOCK, MODELS 20/19, 40/19, 55/192Cleared 510(K)
- K060860TURKOM-CERA2Cleared 510(K)
- K060441VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX982Cleared 510(K)
- K060104PRISMATIK CLINICAL ZIRCONIA2Cleared 510(K)
- K060086FENIIIIIIX COLORATION KIT2Cleared 510(K)
- K053438GLASS CERAMICS2Cleared 510(K)
- K052710VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,2Cleared 510(K)
- K052304SUPER PORCELAIN EX-3 PRESS2Cleared 510(K)
- K052033VINTAGE ZR2Cleared 510(K)
- K052543HERACERAM ZIRKONIA2Cleared 510(K)
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Non-Sterile Zirconia Block
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201492
- 510(k) Type
- Traditional
- Applicant
- Bioden Co., Ltd
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/10/2021
- Days to Decision
- 279 days
- Submission Type
- Summary