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510(k) Data Aggregation
K Number
K210910Device Name
Snore Bandit
Manufacturer
Date Cleared
2021-07-01
(94 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
SnoreBandit LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Snore Bandit is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
Device Description
The Snore Bandit Anti-Snoring Appliance advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The Snore Bandit uses the common 'boil-and bite' technique familiar to athletes who heat and mold their mouth guard to fit their teeth. In this process, the user softens the mouthpiece in hot water according to detailed directions provided with packaging. The user bites into the softened plastic and compresses the softened material to their teeth and gums while holding the jaw slightly forward until the material cools and stiffens. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring. The product is non-sterile and provided in a sealed box with instructions.
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