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
- QMJPowered Radiofrequency Toothbrush2Product Code
- QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea2Product Code
- KJJCleanser, Root CanalUProduct Code
- K201785EPIEN Dental CleanserUCleared 510(K)
- K211813TritonUCleared 510(K)
- K193357V-MixUCleared 510(K)
- K193409Vista Rinse, Vista Rinse PlusUCleared 510(K)
- K200330RC-Prime Root Canal Preparation CreamUCleared 510(K)
- K173163ChlorCid, ChlorCid V, ChlorCid SurfUCleared 510(K)
- K162311Straumann PrefGelUCleared 510(K)
- K160577PacEndo ChlorhexidineUCleared 510(K)
- K153528PacEndo EDTAUCleared 510(K)
- K151852PacEndo Sodium HyprochloriteUCleared 510(K)
- K150020Irritrol, EDS Combo-RinseUCleared 510(K)
- K141352ENDOCYN ROOT CANAL IRRIGATION SOLUTIONUCleared 510(K)
- K140846EDS COMBO-RINSEUCleared 510(K)
- K130180CLEANSER ROOT CANALUCleared 510(K)
- K123538EPIEN ROOT CANAL CLEANSERUCleared 510(K)
- K112250CHX=CHX PLUSUCleared 510(K)
- K103244QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTIONUCleared 510(K)
- K082470SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRAUCleared 510(K)
- K072555EDTA PLUSUCleared 510(K)
- K070401ENDO-CHXUCleared 510(K)
- K063812STRAUMANN PREFGELUCleared 510(K)
- K063703CITRIC ACID 20% SOLUTION, MODEL 329UCleared 510(K)
- K061689AQUATINE EC ENDODONTIC CLEANSERUCleared 510(K)
- K060335FILE-EZEUCleared 510(K)
- K053167BIOPURE MTAD ROOT CANAL CLEANSERUCleared 510(K)
- K032361ENDOPURE ROOT CANAL CLEANSERUCleared 510(K)
- K032627ULTRADENT CITRIC ACID 10% SOLUTIONUCleared 510(K)
- K030884APTUS BLUEUCleared 510(K)
- K024198SMEARCLEARUCleared 510(K)
- K003422EDTA ROOT CANAL CLEANSERUCleared 510(K)
- K992919OXY-GLIDE ROOT CANAL CLEANSER & LUB.UCleared 510(K)
- K992484RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNGUCleared 510(K)
- K962743PULPDENT SODIUM HYPOCHLORITE SOLUTIONUCleared 510(K)
- K950365MOYCO-EDTAUCleared 510(K)
- K934415FILE-EZEUCleared 510(K)
- K921713DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANTUCleared 510(K)
- K830814POINT, PAPER ENDODONTICUCleared 510(K)
- K802853CLEANSER, ROOT CANALUCleared 510(K)
- K780003ENDOSOLV EUCleared 510(K)
- LFDSaliva, ArtificialUProduct Code
- LMWSolution, Removal, Carries3Product Code
- LPGMaterial, Dressing, Surgical, Polylactic Acid3Product Code
- LQYLocator, Root ApexUProduct Code
- 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
- 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
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- 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
FILE-EZE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K934415
- 510(k) Type
- Traditional
- Applicant
- ULTRADENT PRODUCTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/13/1994
- Days to Decision
- 215 days
- Submission Type
- Statement