Anesthesiology
Review Panel
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- 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
- K243910RetraxilUCleared 510(K)
- K211420Stasis GelUCleared 510(K)
- K211419Gingi-Aid GelUCleared 510(K)
- K213149VOCO Retraction PasteUCleared 510(K)
- K200764STATSTIXUCleared 510(K)
- K193389Vista ClearUCleared 510(K)
- K190220Vista FS, Vista FS LiquidUCleared 510(K)
- K171577Smartcord, Smartcord XUCleared 510(K)
- K162662GingiDent Gingival Retraction PasteUCleared 510(K)
- K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsUCleared 510(K)
Show All 34 Submissions
- KJJCleanser, Root CanalUProduct Code
- 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
- SBCDental Image Analyzer2Product Code
- QJXCaries Detection Product With Drug Or Biologic3Product 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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Retraxil
- Page Type
- Cleared 510(K)
- 510(k) Number
- K243910
- 510(k) Type
- Traditional
- Applicant
- Kulzer, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/24/2025
- Days to Decision
- 279 days
- Submission Type
- Summary