Anesthesiology
Review Panel
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- 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
- K252004enCore Night GuardUCleared 510(K)
- K251778Remi Custom Night GuardUCleared 510(K)
- K250456Dentemp Pro-Comfort Dental GuardUCleared 510(K)
- K240810Anti Grinding GuardUCleared 510(K)
- K232238Goyo Mouthpiece SUCleared 510(K)
- K231865Mouth Guard (ATG0603R)UCleared 510(K)
- K221369FBCC Night GuardUCleared 510(K)
- K222424Protect-It Custom Fit Dental GuardUCleared 510(K)
- K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardUCleared 510(K)
- K211158NTI ClenchGuardUCleared 510(K)
- K202974DenTek Fresh Protect Dental GuardUCleared 510(K)
- K193577SleepRight ProRx Custom Dental GuardUCleared 510(K)
- K181005ClenchGuardUCleared 510(K)
- K183315CustMBite Dental GuardUCleared 510(K)
- K191033LunaGuard Nighttime Dental ProtectorUCleared 510(K)
- K181099Bright GuardUCleared 510(K)
- K180933DenTek Ultimate Dental GuardUCleared 510(K)
- K172452BruxorUCleared 510(K)
- K172223SleepRight ProRx Custom Dental GuardUCleared 510(K)
- K150492Ora-GUARD Dental Grind GuardUCleared 510(K)
- K151149Ready-FitUCleared 510(K)
- K132469THE BITE GUARDUCleared 510(K)
- K133037GRINDGUARDUCleared 510(K)
- K133423REST ASSURED EXTRA COMFORT NITE PROTECTORUCleared 510(K)
- K123849NEW COMFORT-FIT DENTAL GUARDUCleared 510(K)
- K121272PROTECH DENTUCleared 510(K)
- K113326ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARDUCleared 510(K)
- K120103REST ASSURED GENERATION III DENTAL PROTECTORUCleared 510(K)
- K112879REST ASSURED READY TO WEAR NITE PROTECTORUCleared 510(K)
- K111310BRUX MOUTHGUARDSUCleared 510(K)
- K100545SLEEPRIGHTUCleared 510(K)
- K094020GRIND NO MORE GENERATION IIUCleared 510(K)
- K091792REST ASSURED GENERATION II DENTAL PROTECTORUCleared 510(K)
- K091660CUSTOM COMFORT NIGHTGUARD VERSION 2UCleared 510(K)
- K091175GRIND NO MORE VERSION 2 AND 3UCleared 510(K)
- K083400CUSTOM COMFORT NIGHTGUARDUCleared 510(K)
- K082301GRIND NO MOREUCleared 510(K)
- K081669IMPROVED COMFORT-FIT NIGHTGUARDUCleared 510(K)
- K072968STRESSGARD NIGHTGUARDUCleared 510(K)
- K073446GRIND GUARDUCleared 510(K)
- K073220THE DOCTOR'S NIGHTGUARD ADVANCED COMFORTUCleared 510(K)
- K072147DEN TEK COMFORT FIT NIGHTGUARDUCleared 510(K)
- K063229REST ASSURED NITE PROTECTORUCleared 510(K)
- 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
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SleepRight ProRx Custom Dental Guard
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K193577
- 510(k) Type
- Traditional
- Applicant
- Splintek, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/1/2020
- Days to Decision
- 161 days
- Submission Type
- Summary