Anesthesiology
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- 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
- K243353One-Fil Putty2Cleared 510(K)
- K243546AH Plus Endodontic Sealer2Cleared 510(K)
- K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)2Cleared 510(K)
- K242702VioSeal2Cleared 510(K)
- K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)2Cleared 510(K)
- K241457Vista BC Putty2Cleared 510(K)
- K240446Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +2Cleared 510(K)
- K240304Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)2Cleared 510(K)
- K240365Bioceramic Root Repair Material (C-Root BP)2Cleared 510(K)
- K232182One-Fil2Cleared 510(K)
- K232299CeraPutty2Cleared 510(K)
- K231480Bright MTA Sealer Plus2Cleared 510(K)
- K231387Endofill2Cleared 510(K)
- K231259iRoot SP Plus2Cleared 510(K)
- K230010ADSEAL Plus2Cleared 510(K)
- K230797SmartMTA Capsule2Cleared 510(K)
- K213757Endocem MTA Premixed Regular2Cleared 510(K)
- K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material2Cleared 510(K)
- K221811Vista BC Sealer2Cleared 510(K)
- K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid2Cleared 510(K)
- K212983Injectable Root Canal Bioceramic Sealer2Cleared 510(K)
- K211905UltraCal XS2Cleared 510(K)
- K212283BioRoot Flow 0.5g, BioRoot Flow 2g2Cleared 510(K)
- K211995Sonendo Filling Material 5C2Cleared 510(K)
- K212229White Endoseal MTA2Cleared 510(K)
- K211799Biodentine XP 500, Biodentine XP 2002Cleared 510(K)
- K210904Metapaste Plus2Cleared 510(K)
- K202617Metapex Plus2Cleared 510(K)
- K210333DiaPaste2Cleared 510(K)
- K202015White ENDOSEAL MTA2Cleared 510(K)
- K202281EDS Bioceramic Sealer (Bioseal)2Cleared 510(K)
- K201222Bio-C Repair Ion+2Cleared 510(K)
- K200174DIA-ROOT BIO MTA2Cleared 510(K)
- K200175DIA-ROOT BIO Sealer2Cleared 510(K)
- K190091Diapaste2Cleared 510(K)
- K190537BIO-C Sealer Ion+2Cleared 510(K)
- K182009Dia-Proseal2Cleared 510(K)
- K190503CeraSeal2Cleared 510(K)
- K182625Diapex Plus2Cleared 510(K)
- K190510GuttaSil2Cleared 510(K)
- K181917MTA2.3 MATERIALS2Cleared 510(K)
- K180199BIO-C TEMP2Cleared 510(K)
- K181922Sonendo Material A2Cleared 510(K)
- K180185BIO-C REPAIR2Cleared 510(K)
- K170175ENDOSEAL MTA2Cleared 510(K)
- K172839ENDOSOLV2Cleared 510(K)
- K172701BIO-C SEALER2Cleared 510(K)
- K170950Well-Root ST2Cleared 510(K)
- K170207Obturys2Cleared 510(K)
- K162661SavDenTM MTA Root Canal Filling Materials2Cleared 510(K)
- K161239MTA2.2 MATERIAL2Cleared 510(K)
- K151047MTA Repair HP2Cleared 510(K)
- K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress2Cleared 510(K)
- K152956Pulp Canal Sealer, Pulp Canal Sealer EWT2Cleared 510(K)
- K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes2Cleared 510(K)
- K142178PROROOT MTA WHITE, PROROOT MTA GRAY2Cleared 510(K)
- K130312IROOT FM2Cleared 510(K)
- K140132BIODENTINE2Cleared 510(K)
- K140955MTA2.1 MATERIAL2Cleared 510(K)
- K133042ENDOCEM ZR2Cleared 510(K)
- K133054ENDOSEAL2Cleared 510(K)
- K140247MTA FILLAPEX2Cleared 510(K)
- K132825RETROMTA-ORTHOMTA II2Cleared 510(K)
- K133716TRC-PASTE2Cleared 510(K)
- K132123TRC-PEX, RADIC-SEALER2Cleared 510(K)
- K123276MM-SEAL2Cleared 510(K)
- K130601BIOROOT RCS2Cleared 510(K)
- K130125MTA CEMENTS2Cleared 510(K)
- K122892MTA2 ROOT AND PULP MATERIALS2Cleared 510(K)
- K113568MTA-FILLAPEX2Cleared 510(K)
- K120048DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S2Cleared 510(K)
- K112078ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)2Cleared 510(K)
- K112046MTA ANGELUS2Cleared 510(K)
- K102867IROOT FS2Cleared 510(K)
- K102575ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)2Cleared 510(K)
- K100248DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S2Cleared 510(K)
- K102163REALSEAL XT SEALER2Cleared 510(K)
- K093208SIMPLISEAL2Cleared 510(K)
- K092251BIODENTINE2Cleared 510(K)
- K092715IROOT BP PLUS2Cleared 510(K)
- K090992WELL-PASTE2Cleared 510(K)
- K083062ROOT CANAL XR2Cleared 510(K)
- K082943IROOT BP, MODEL IRBP 46092Cleared 510(K)
- K080917IROOT SP2Cleared 510(K)
- K080203MTA ROOT CANAL SEALER2Cleared 510(K)
- K080266WELL-PEX2Cleared 510(K)
- K073218MTA ADVANCED MATERIAL2Cleared 510(K)
- K071106ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 3992Cleared 510(K)
- K063856EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM2Cleared 510(K)
- K063422BIOAGGREGATE2Cleared 510(K)
- K060889SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE2Cleared 510(K)
- K060946CZ-S20002Cleared 510(K)
- K042769ADSEAL ROOT CANAL SEALER2Cleared 510(K)
- K042756ENDOREZ2Cleared 510(K)
- K033585DIAPEX2Cleared 510(K)
- K032662GUTTAFLOW2Cleared 510(K)
- K032605METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING2Cleared 510(K)
- K032603METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING2Cleared 510(K)
- K023818FIBERFILL AGP2Cleared 510(K)
- K023976ACROSEAL ROOT CANAL OR APICAL SEALER2Cleared 510(K)
- K022734PULPDENT CALCIUM HYDROXIDE PREPARATION2Cleared 510(K)
- K011748FIRST FILL R.C.S.2Cleared 510(K)
- K010940SEALAPEX 42Cleared 510(K)
- K011009WHITE MTA MATERIAL2Cleared 510(K)
- K992727THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM2Cleared 510(K)
- K992097ENDOREZ2Cleared 510(K)
- K983037ROEKO SEAL2Cleared 510(K)
- K981620MTA MATERIAL II2Cleared 510(K)
- K980633ENDOSOLV E2Cleared 510(K)
- K980332MTA MATERIAL2Cleared 510(K)
- K973667VITAPEX PRE-LOADED DENTAL SYRINGE2Cleared 510(K)
- K972369SEALAPEX2Cleared 510(K)
- K971899ENDO-SEAL2Cleared 510(K)
- K971622MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM2Cleared 510(K)
- K964174MINERAL TRIOXIDE AGGREGATE (MTA)2Cleared 510(K)
- K963922ALPHA-DENT ROOT CANAL SEALER & FILLER2Cleared 510(K)
- K962885SEALEX EXTRA ROOT CANAL SEALER2Cleared 510(K)
- K955703NEO DENTAL ENDODONTIC IRRIGATION SYRINGE2Cleared 510(K)
- K960548AH PLUS ROOT CANAL SEALER2Cleared 510(K)
- K946138PULPDENT ROOT CANAL SEALER2Cleared 510(K)
- K940368CANAL KING (THIN) CANAL KING (THICK)2Cleared 510(K)
- K942393TUBLI-SEAL EWT2Cleared 510(K)
- K930872ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA2Cleared 510(K)
- K932791PULPDENT EDTA PREPARATIONS2Cleared 510(K)
- K914325ROOT CANAL FILLING CEMENT2Cleared 510(K)
- K896657ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA2Cleared 510(K)
- K896656ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH2Cleared 510(K)
- K894092DENTAL ENDODONTIC CEMENT (MODIFICATION)2Cleared 510(K)
- K893794APEXIT ROOT CANAL SEALER2Cleared 510(K)
- K854253ROOT CANAL FILLING RESIN2Cleared 510(K)
- K844635HYDROSET ROOT CANAL SEALER2Cleared 510(K)
- K830763FR ROOT CANAL FILLER2Cleared 510(K)
- K820284ROOT CANAL FILLING RESIN2Cleared 510(K)
- K810923LEE ENDOFILL, ROOT CANAL FILLING RESIN2Cleared 510(K)
- K801482HYDRON ROOT CANAL FILLING MATERIAL2Cleared 510(K)
- K771921HYDRON ROOT CANAL FILLING SYSTEM2Cleared 510(K)
- 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
iRoot SP Plus
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K231259
- 510(k) Type
- Special
- Applicant
- Innovative BioCeramix, Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/31/2023
- Days to Decision
- 30 days
- Submission Type
- Summary