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
- K242646Dental Implant Unit1Cleared 510(K)
- K233288NLZ Built-In Motor System1Cleared 510(K)
- K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)1Cleared 510(K)
- K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,1Cleared 510(K)
- K231864Fiber Optic Brushless Electronic Micromotor, model: iM1001Cleared 510(K)
- K211358Implanter incl. Accessories1Cleared 510(K)
- K220831Dental Implantation Systems, Dental Electrical Motors1Cleared 510(K)
- K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED1Cleared 510(K)
- K202075Dental Electric Motor1Cleared 510(K)
- K201191ELEC-LED1Cleared 510(K)
- K203706Dental Electric Motor1Cleared 510(K)
- K201192Impla-NX (Model: ISE-270M)1Cleared 510(K)
- K201292TRAUS SIP201Cleared 510(K)
- K193341iCTmotor (WL-1)1Cleared 510(K)
- K180845Maxima Electric System1Cleared 510(K)
- K181858Electric Handpiece Motor1Cleared 510(K)
- K173905Surgic Pro, Surgic Pro+1Cleared 510(K)
- K163402NLZ Motor System1Cleared 510(K)
- K163131A-dec NLZ Electric Motor System1Cleared 510(K)
- K163317ELECTROmatic1Cleared 510(K)
- K161213XSmart iQ1Cleared 510(K)
- K161957W&H Implantmed SI-1015 incl. Accessories1Cleared 510(K)
- K141482KI-201Cleared 510(K)
- K140308MASTERSURG / EXPERTSURG1Cleared 510(K)
- K133776A-DEC/W&H ELECTRIC HANDPIECE MOTOR1Cleared 510(K)
- K132570ELECTRIC HANDPIECE SYSTEM1Cleared 510(K)
- K123608ENDO E CLASS1Cleared 510(K)
- K111623I-ENDO DUAL1Cleared 510(K)
- K103027ELECTROTORQUE TLC1Cleared 510(K)
- K103653E3 TORQUE CONTROL MOTOR1Cleared 510(K)
- K102241ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT1Cleared 510(K)
- K100785BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES1Cleared 510(K)
- K092214CHIROPRO L SYSTEM1Cleared 510(K)
- K092758X-CUBE1Cleared 510(K)
- K090727IMM DENTAL IRRIGATION TUBING SET1Cleared 510(K)
- K090937E-STATIS 40 SYSTEM1Cleared 510(K)
- K083252NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM1Cleared 510(K)
- K060287DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM1Cleared 510(K)
- K052741IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES1Cleared 510(K)
- K041124IRRIGATION TUBING SET 2.2M AND 3.8M1Cleared 510(K)
- K040153I-TEC PORTABLE DENTAL OPERATORY1Cleared 510(K)
- K032572A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT1Cleared 510(K)
- K031584SIROTORQUE L1Cleared 510(K)
- K014068ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 1151Cleared 510(K)
- K020327SURGIC IV IMPLANT CONTROL UNIT1Cleared 510(K)
- K011926ELEC-MATE E1Cleared 510(K)
- K002469IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)1Cleared 510(K)
- K000120PRO-TORQ1Cleared 510(K)
- K992648ROTARY MASTER1Cleared 510(K)
- K990954ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET1Cleared 510(K)
- K972889ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)1Cleared 510(K)
- K972924SURGIC II IMPLANT CONTROL UNIT1Cleared 510(K)
- K964860MARK 20 AND MARK 25 HAND ENGINE CONTROLLER1Cleared 510(K)
- K964863MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN1Cleared 510(K)
- K905620MODIFIED SITE PERISTALTIC FOOTSWITCH1Cleared 510(K)
- K790322OPTIONAL ACCESSORY FOOT SWITCH MODEL 1001Cleared 510(K)
- K770129SPRINT S-2 INSTRU. CENTER (MODEL 92329)1Cleared 510(K)
- 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
- 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
X-CUBE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K092758
- 510(k) Type
- Traditional
- Applicant
- SAESHIN PRECISION CO., LTD.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/21/2009
- Days to Decision
- 12 days
- Submission Type
- Summary