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
- DZJDriver, Wire, And Bone Drill, Manual2Product Code
- DZKWire, Fixation, Intraosseous2Product Code
- DZLScrew, Fixation, Intraosseous2Product Code
- DZMNeedle, Dental1Product Code
- DZNInstruments, Dental Hand1Product Code
- DZPInstrument, Diamond, Dental1Product Code
- DYXLock, Wire, And Ligature, Intraoral2Product Code
- DZADrill, Dental, Intraoral1Product Code
- DZHSaw, Bone, Ac-Powered2Product Code
- DZIDrill, Bone, Powered2Product Code
- EAXMirror, Mouth1Product Code
- EAYLight, Fiber Optic, Dental1Product Code
- EAZLight, Operating, Dental1Product Code
- EBALight, Surgical Headlight1Product Code
- EBWController, Foot, Handpiece And Cord1Product Code
- ECBUnit, Syringe, Air And/Or Water1Product Code
- ECPInstrument, Ligature Tucking, Orthodontic1Product Code
- ECQAligner, Bracket, Orthodontic1Product Code
- ECRSetter, Band, Orthodontic1Product Code
- ECSPusher, Band, Orthodontic1Product Code
- ECTDriver, Band, Orthodontic1Product Code
- EFAHandpiece, Belt And/Or Gear Driven, Dental1Product Code
- EFBHandpiece, Air-Powered, Dental1Product Code
- EFKForceps, Articulation Paper1Product Code
- EFLForceps, Dressing, Dental1Product Code
- EGIParallelometer1Product Code
- EGMInjector, Jet, Mechanical-Powered2Product Code
- EGNScissors, Surgical Tissue, Dental1Product Code
- EGQInjector, Jet, Gas-Powered2Product Code
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental1Product Code
- EIBSyringe, Irrigating (Dental)1Product Code
- EICSyringe, Periodontic, Endodontic, Irrigating1Product Code
- EIDSyringe, Restorative And Impression Material1Product Code
- EIFAccessories, Retractor, Dental1Product Code
- EIGRetractor, All Types1Product Code
- EIKCarver, Wax, Dental1Product Code
- EILGauge, Depth, Instrument, Dental1Product Code
- EIRScissors, Collar And Crown1Product Code
- EISRemover, Crown1Product Code
- EIXProbe, Periodontic1Product Code
- EIYInstrument, Filling, Plastic, Dental1Product Code
- EJBHandle, Instrument, Dental1Product Code
- EJYPliers, Operative1Product Code
- EJZKnife, Margin Finishing, Operative1Product Code
- EKAFile, Margin Finishing, Operative1Product Code
- EKBExplorer, Operative1Product Code
- EKCExcavator, Dental, Operative1Product Code
- EKDInstrument, Cutting, Operative1Product Code
- EKECurette, Operative1Product Code
- EKFInstrument, Contouring, Matrix, Operative1Product Code
- EKGCondenser, Amalgam And Foil, Operative1Product Code
- EKHCarver, Dental Amalgam, Operative1Product Code
- EKICarrier, Amalgam, Operative1Product Code
- EKJBurnisher, Operative1Product Code
- EKKSpreader, Pulp Canal Filling Material, Endodontic1Product Code
- EKPReamer, Pulp Canal, Endodontic1Product Code
- EKQPreparer, Root Canal Endodontic1Product Code
- EKRPlugger, Root Canal, Endodontic1Product Code
- EKSFile, Pulp Canal, Endodontic1Product Code
- EKTCurette, Endodontic1Product Code
- EKWBroach, Endodontic1Product Code
- EKXHandpiece, Direct Drive, Ac-Powered1Product Code
- K252223Alpha Endo Handpiece (Alpha Endo)1Cleared 510(K)
- K251597InnerView System1Cleared 510(K)
- K243692EnDrive (EnDriveUS)1Cleared 510(K)
- K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)1Cleared 510(K)
- K241065ChecQ (AC100)1Cleared 510(K)
- K243911HPR Cordless Hygiene Handpiece1Cleared 510(K)
- K222688The Trust1Cleared 510(K)
- K233865X-Smart Pro; X-Smart Pro+1Cleared 510(K)
- K232551EM-07 Cordless Endo Motor1Cleared 510(K)
- K232810Dental Handpiece, Wireless Endodontic Handpiece, endoit1Cleared 510(K)
- K232657InnerView LC1Cleared 510(K)
- K220829Endo Motor1Cleared 510(K)
- K222548Endo Motor1Cleared 510(K)
- K210475EQ-M1Cleared 510(K)
- K213897Pro M Class1Cleared 510(K)
- K212043TRAUS ENDO1Cleared 510(K)
- K211531Cordless Prophy System, Model: i-Polish1Cleared 510(K)
- K203320Endo Motor1Cleared 510(K)
- K192649Endo Motor1Cleared 510(K)
- K201703PROXEO Twist Cordless Polishing System PL-40 H1Cleared 510(K)
- K201993E-connect S Endo Motor with built-in Apex Locator1Cleared 510(K)
- K191276Dental Electrical Motor iRoot Pro1Cleared 510(K)
- K181888Osstell Beacon1Cleared 510(K)
- K180682AeroPro Cordless Prophy System1Cleared 510(K)
- K180953AnyCheck IMT-1001Cleared 510(K)
- K173920LS OIL1Cleared 510(K)
- K171377Young INFINITY Cordless Handpiece System1Cleared 510(K)
- K180527IS31Cleared 510(K)
- K170275Tri Auto ZX21Cleared 510(K)
- K161500MEG-TORQ1Cleared 510(K)
- K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology1Cleared 510(K)
- K153285EMS-2001Cleared 510(K)
- K143445Tellos ISQ Buddy1Cleared 510(K)
- K143411TRAUS ENDO1Cleared 510(K)
- K150129AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)1Cleared 510(K)
- K142358Osstell IDx1Cleared 510(K)
- K142124AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM1Cleared 510(K)
- K133298ENDO SMART1Cleared 510(K)
- K132401MEGA ISQ1Cleared 510(K)
- K131578IPROPHY MOBILE1Cleared 510(K)
- K123582ENDO A CLASS1Cleared 510(K)
- K112665TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE1Cleared 510(K)
- K110278CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD9001Cleared 510(K)
- K111616E-CUBE1Cleared 510(K)
- K111078AEU-26L ELCTRONIC ENDODONTIC SYSTEM1Cleared 510(K)
- K110753MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM1Cleared 510(K)
- K103399GENERAL DENISTRY MOTOR1Cleared 510(K)
- K100600PROSTHODONTIC SCREWDRIVER , MODEL IA-4001Cleared 510(K)
- K101612ZEN CORDLESS PROPHY SYSTEM1Cleared 510(K)
- K092833ENDOMAX CORDLESS ENDODONTIC HANDPIECE1Cleared 510(K)
- K090931CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR1Cleared 510(K)
- K092614X-SMART EASY1Cleared 510(K)
- K091913HI TECH IMPLANT, HT PHYSIO IMPLANT1Cleared 510(K)
- K082325APEXUM ABLATOR1Cleared 510(K)
- K082523OSSTELL ISQ IMPLANT STABILITY METER1Cleared 510(K)
- K072213PERIMETRICS PERIOMETER1Cleared 510(K)
- K081191TCM ENDO 201Cleared 510(K)
- K071190ROOT ZX II1Cleared 510(K)
- K063007POWERTOME PERIOTOME1Cleared 510(K)
- K052515SIROENDO1Cleared 510(K)
- K051661IMPLANT HANDPIECES1Cleared 510(K)
- K050612LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE1Cleared 510(K)
- K042822TCM ENDO V, MODEL 15341Cleared 510(K)
- K041279IMPLANTEO IMPLANTOLOGY MOTOR1Cleared 510(K)
- K033689OSSTELL MENTOR RFA1Cleared 510(K)
- K033597ATR 5000, LC 5000, IMPLANT SYSTEM1Cleared 510(K)
- K031204DENTAPORT ZX1Cleared 510(K)
- K031540APEX ELECTRIC HANDPIECE SYSTEM1Cleared 510(K)
- K030163ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-9251Cleared 510(K)
- K012944POWER DRIVE1Cleared 510(K)
- K003714OSSTELL RESONANCE FREQUENCY ANALYZER1Cleared 510(K)
- K993188ENDOSTEPPER 11Cleared 510(K)
- K990739QUANTEC-E ENDO SYSTEM1Cleared 510(K)
- K990682PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)1Cleared 510(K)
- K990646PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE1Cleared 510(K)
- K983413MODEL MS-1 HANDPIECE1Cleared 510(K)
- K970339TRI AUTO ZX1Cleared 510(K)
- K932600MODIFIED SITE POWER HANDPIECE II1Cleared 510(K)
- K915634FRESENIUS PD+ EXCHANGE DEVICE1Cleared 510(K)
- K922077MODIFIED SITE POWER HANDPIECE1Cleared 510(K)
- K905071MX CYCLER1Cleared 510(K)
- K872171PERIOTEST1Cleared 510(K)
- K870797PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE1Cleared 510(K)
- K832063ROBIN CORDLESS HANDPIECE1Cleared 510(K)
- K821739J. MORITA FLEX M-3 TORX HARDPIECE1Cleared 510(K)
- K813348YOSHIDA RIDO-F, MODEL LM-011Cleared 510(K)
- K801687TORX MICRO-MOTOR LOW SPEED HANDPIECE1Cleared 510(K)
- K780646AIR-PWOERED COLDRILL1Cleared 510(K)
- K760724PERITONEAL DIALYSIS SYSTEM1Cleared 510(K)
- EKYHandpiece, Water-Powered1Product Code
- EKZUnit, Electrosurgical, And Accessories, Dental2Product Code
- ELAInstrument, Hand, Calculus Removal1Product Code
- ELBScaler, Rotary2Product Code
- ELCScaler, Ultrasonic2Product Code
- EMDHemostat, Surgical1Product Code
- EMEPunch, Biopsy, Surgical1Product Code
- EMGForceps, Tooth Extractor, Surgical1Product Code
- EMHForceps, Rongeur, Surgical1Product Code
- EMIFile, Bone, Surgical1Product Code
- EMJElevator, Surgical, Dental1Product Code
- EMKCurette, Surgical, Dental1Product Code
- EMLChisel, Bone, Surgical1Product Code
- EMMChisel, Osteotome, Surgical1Product Code
- EMNScaler, Periodontic1Product Code
- EMOKnife, Periodontic1Product Code
- EMPMarker, Periodontic1Product Code
- EMQHoe, Periodontic1Product Code
- EMRFile, Periodontic1Product Code
- EMSCurette, Periodontic1Product Code
- JEPRetainer, Matrix1Product Code
- JEXPlier, Orthodontic1Product Code
- JEYPlate, Bone2Product Code
- KMWHandpiece, Rotary Bone Cutting2Product Code
- MDLImplant, Transmandibular2Product Code
- MQNExternal Mandibular Fixator And/Or Distractor2Product Code
- MXFSystem, Dental, Hydrokinetic, Caries Removal & Cavity Preparation2Product Code
- NEIProsthesis, Condyle, Mandibular, Temporary2Product Code
- NLDInstrument, Diamond, Dental, Reprocessed1Product Code
- NMWNeedle, Dental, Reprocessed1Product Code
- NYCDental Prophylaxis Kit1Product Code
- NYFGingival Retraction Kit1Product Code
- NYGLapping Tool Kit1Product Code
- NYLHandpiece, Air-Powered, Root Canal Irrigation1Product Code
- PLVDental Stereotaxic Instrument2Product Code
- PWLOral Surgery Tray1Product Code
- NVKLaser, Dental, Soft Tissue2Product Code
- OAJCatheter, Drainage, Intraoral/Extraoral1Product Code
- PEMDental Barriers And Sleeves2Product Code
- QRYDental Navigation System2Product Code
- 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
IS3
- Page Type
- Cleared 510(K)
- 510(k) Number
- K180527
- 510(k) Type
- Traditional
- Applicant
- Hiossen, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/16/2018
- Days to Decision
- 77 days
- Submission Type
- Summary