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510(k) Data Aggregation
K Number
K191033Device Name
LunaGuard Nighttime Dental Protector
Manufacturer
Date Cleared
2019-08-05
(109 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
McKeon Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LunaGuard™ Nighttime Dental Protector is indicated for use in protecting the teeth and reducing damage caused by bruxism or nighttime grinding.
Device Description
The LunaGuard™ Nighttime Dental Protector is an over-the-counter, flexible and moldable one-piece dental guard consisting of a lightweight polycaprolactone (PCL) plastic material can diffuse and absorb grinding forces, along with the microperforations in the mouthguard, to protect the teeth from the grinding and clenching associated with bruxism.
When in place over the upper teeth, the guard maintains separation between upper and lower teeth, reducing noise and damage associated with teeth grinding. It is designed to fit around the teeth with no or minimal space in order to form a barrier between the upper and lower teeth. The lightweight, thin design allows for comfort while sleeping, and does not impede speaking, drinking, or breathing.
The LunaGuard™ material is self-fit by the user using the "boil and bite" method. Once submerged in hot but not boiling water, the dental guard turns clear when it reaches 160 degrees Fahrenheit (71.1 degrees Celsius), indicating readiness to mold. At this point, the user shapes the dental guard around their upper teeth for a snug and user-specific fit.
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