Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview 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
- 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
- K252425Silatrix Oral GelUCleared 510(K)
- K241283Elemental GranulateUCleared 510(K)
- K230529HealiAid Dental Collagen Wound DressingUCleared 510(K)
- K221428PerioStom Dental DressingUCleared 510(K)
- K211851Ora-AidUCleared 510(K)
- K210211PuraStat-OMUCleared 510(K)
- K203091MucoLock Oral GelUCleared 510(K)
- K202000Silatrix Oral GelUCleared 510(K)
- K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseUCleared 510(K)
- K191987OrapeuticUCleared 510(K)
- K183436OraCureUCleared 510(K)
- K173196SUNTOUCH Dental DressingUCleared 510(K)
- K130959AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GELUCleared 510(K)
- K112568AONGEN DENTAL COLLAGEN MATRIXUCleared 510(K)
- K101769EPISILUCleared 510(K)
- K110750PERIOPATCHUCleared 510(K)
- K103054PERIOPATCHUCleared 510(K)
- K090612BENACELUCleared 510(K)
- K081372GELX ORAL GELUCleared 510(K)
- K082553REXASTOM ORAL EASEUCleared 510(K)
- K082856CARAPASTE ORAL WOUND DRESSINGUCleared 510(K)
- K070842ULCELOOCIN ORAL ULCER PATCHUCleared 510(K)
- K053342GENGIGEL MOUTHRINSEUCleared 510(K)
- K063148SOCK IT! ORAL PAIN GELUCleared 510(K)
- K062795MUGARD MUCOADHESIVE ORAL WOUND RINSEUCleared 510(K)
- K060363HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12UCleared 510(K)
- K060340ORAMAGIC PLUS ORAL WOUND RINSEUCleared 510(K)
- K042722ALOCLAIR ORAL SPRAYUCleared 510(K)
- K042400MUCOTROL CONCENTRATED ORAL GEL WAFERUCleared 510(K)
- K040950ALOCLAIR ORAL GELUCleared 510(K)
- K024180ORAMAGICRX ORAL WOUND RINSEUCleared 510(K)
- K023155ALOCLAIR ORAL RINSEUCleared 510(K)
- K013056GELCLAIR CONCENTRATED ORAL GELUCleared 510(K)
- K012126THE SALICEPT ORAL PATCHUCleared 510(K)
- K983182ALOE THERAPY ORAL RINSEUCleared 510(K)
- K964852RADIACARE ORAL WOUND RINSEUCleared 510(K)
- 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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- ToxicologyReview Panel
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- UnknownReview Panel
OraCure
- Page Type
- Cleared 510(K)
- 510(k) Number
- K183436
- 510(k) Type
- Traditional
- Applicant
- TBM Corporation
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/18/2019
- Days to Decision
- 281 days
- Submission Type
- Summary