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
- K250743Remvia NightGuardUCleared 510(K)
- K251252NOBILCAM IMPAK DiscUCleared 510(K)
- K241729Hard Splint & Thermo-Adaptive SplintUCleared 510(K)
- K243516Remi Custom Night GuardUCleared 510(K)
- K241369LIJIA Night GuardUCleared 510(K)
- K231775GR Resin System MSIUCleared 510(K)
- K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)UCleared 510(K)
- K240463Slow Wave DS8 (SWDS802)UCleared 510(K)
- K231793RODIN 3D Resin SPLINT, Hard/FlexUCleared 510(K)
- K232087Dental LT Comfort ResinUCleared 510(K)
Show All 70 Submissions
- 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
- 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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- UnknownReview Panel
Remi Custom Night Guard
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K243516
- 510(k) Type
- Traditional
- Applicant
- Grindguard, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/10/2025
- Days to Decision
- 89 days
- Submission Type
- Summary