Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- LTGPaste, Injectable For Vocal Cord Augmentation3Product Code
- LWMDevice, Electrical Dental AnesthesiaUProduct Code
- MCLKit, Test, In Vitro Periodontal3Product Code
- MQCMouthguard, PrescriptionUProduct Code
- MVLCord, RetractionUProduct Code
- KJJCleanser, Root CanalUProduct Code
- LFDSaliva, ArtificialUProduct Code
- LMWSolution, Removal, Carries3Product Code
- LPGMaterial, Dressing, Surgical, Polylactic Acid3Product Code
- LQYLocator, Root ApexUProduct Code
- K242383Apex LocatorUCleared 510(K)
- K242765Electronic Apex Locator (Alpha Apex I)UCleared 510(K)
- K231990Apex LocatorUCleared 510(K)
- K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)UCleared 510(K)
- K212178Root Apex LocatorUCleared 510(K)
- K210789EQ-PEXUCleared 510(K)
- K203836BOMEDENT Apex locator, WISMY Apex locatorUCleared 510(K)
- K191806Propex IQ Apex LocatorUCleared 510(K)
- K181087Apex Locator, DPEX IIIUCleared 510(K)
- K171867Dr’s Finder NEOUCleared 510(K)
- K151274Dr's FinderUCleared 510(K)
- K131907RAYPEX 6UCleared 510(K)
- K121206DETECTUCleared 510(K)
- K112508I-ROOT 100UCleared 510(K)
- K112153IROOT 100 MINIUCleared 510(K)
- K111474BINGO PROUCleared 510(K)
- K103123APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)UCleared 510(K)
- K100450I-ROOTUCleared 510(K)
- K101177APEXNRG RIDERUCleared 510(K)
- K101054ROMIAPEX MODEL A-15UCleared 510(K)
- K090925MULTIPLE (APEX LOCATOR), MODEL RCM-7UCleared 510(K)
- K083901NAVI ROOTUCleared 510(K)
- K073185APX21UCleared 510(K)
- K080113APEX DAL ELECTRONIC APEX LOCATORUCleared 510(K)
- K071133APEXNRG-BLUE ELECTRONIC APEX LOCATORUCleared 510(K)
- K063843APEXNRG XFRUCleared 510(K)
- K053235NSK PRECISION APEX LOCATOR (PAL)UCleared 510(K)
- K032743APEX NRGUCleared 510(K)
- K030895ASEPTICO ENDOPEX V, MODEL AEU-40UCleared 510(K)
- K022147DENTA PORTUCleared 510(K)
- K022020JUSTWO MODEL TME-601 ROOT APEX LOCATORUCleared 510(K)
- K002195FORAMATRON V, MODEL D680UCleared 510(K)
- K992233APEX LOCATOR BINGO-1020UCleared 510(K)
- K972407ROOT APEX LOCATORUCleared 510(K)
- K962803APEX FINDER MODELS 7005UCleared 510(K)
- K962853NEOSONOUCleared 510(K)
- K955088NEOSONO 2000UCleared 510(K)
- K953867ROOT CANAL LENGTH MEASURING DEVICEUCleared 510(K)
- K950857FORAMATRON IVUCleared 510(K)
- K945811PULPDENT CANAL FINDERUCleared 510(K)
- K921979ROOT ZXUCleared 510(K)
- K904742OSADA ENDEXUCleared 510(K)
- K890735COATED APEX PROBEUCleared 510(K)
- K863393ENDOCATERUCleared 510(K)
- K864500ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001UCleared 510(K)
- NSJRestoration, Noble MetalNProduct Code
- NSKDentures, PartialNProduct Code
- NSLDentures, FullNProduct Code
- NSMRestoration, ResinNProduct Code
- NSNRestoration, Resin, Crown And BridgeNProduct Code
- NSORestoration, Porcelain-Fused-To-MetalNProduct Code
- NSPRestoration, PorcelainNProduct Code
- NSQRestoration, Base MetalNProduct Code
- NSRProsthesis, OrthodonticNProduct Code
- NXJDenture, Cosmetic OnlyNProduct Code
- OBRMouthguard, Over-The-CounterUProduct Code
- OCOMouthguard, Migraine/Tension HeadacheUProduct Code
- OLROral Wound DressingUProduct Code
- OLSOral Wound Dressing W/Drug And/Or BiologicUProduct Code
- PKJCrown And Bridge Material, Resin BasedNProduct Code
- QUAIntraoral Cooling Device2Product Code
- SBCDental Image Analyzer2Product Code
- QJXCaries Detection Product With Drug Or Biologic3Product Code
- SGQIntraoral Phototherapy Device2Product Code
- Submissions with No Product CodeMiscellaneous
- 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
- Ear, Nose, ThroatReview Panel
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- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
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- UnknownReview Panel
I-ROOT 100
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K112508
- 510(k) Type
- Traditional
- Applicant
- S-Denti Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/19/2012
- Days to Decision
- 294 days
- Submission Type
- Summary