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510(k) Data Aggregation
K Number
K250028Device Name
Anti Snore MouthpieceDate Cleared
2025-10-03
(270 days)
Product Code
Regulation Number
872.5570Type
TraditionalPanel
DentalReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Anti snore mouthpiece is intended as an aid in the reduction of snoring for adults at least 18 years old.
Device Description
Anti snore mouthpiece is an intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward relative to the maxilla to increase users' pharyngeal space and improve the ability to exchange air and decreases air turbulence, a causative factor in snoring.
AI/ML Overview
N/A
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