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510(k) Data Aggregation
K Number
K110468Device Name
FREEWAY COMFORT BITE GUARD
Manufacturer
RANDMARK DENTAL PRODUCTS, LLC
Date Cleared
2011-08-05
(169 days)
Product Code
MQC, OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
RANDMARK DENTAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. Protection against teeth grinding, bruxism and jaw clenching. Rx: Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
Device Description
The Freeway Comfort" Bite Guard dental guard is composed of a moldable thermoplastic inner lining that adapts to the teeth, and a hard outer shell. The shell is composed of a hard polycarbonate material. When heated, the moldable thermoplastic material is molded to fit the user's upper anterior teeth. The hard outer shell contacts the lower anterior teeth and prevents contact of the user's posterior teeth.
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