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510(k) Data Aggregation
K Number
K133037Device Name
GRINDGUARD
Manufacturer
GRIND GUARD TECHNOLOGIES, LLC
Date Cleared
2014-01-23
(119 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GRIND GUARD TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GrindGuardN is a mouth guard intended to protect against grinding and clenching.
Device Description
The GrindGuard® is an oral appliance consisting of a thin exterior tray (shell) that covers approximately half of the lower or upper arch, with a dome shape protrusion (in the center of the device), to be situated over the central incisors and an internal layer which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and is formed by injection molding. The inner, formable layer consists of polycaprolactone. The GrindGuard® is designed to prevent night grinding.
After a brief submersion in water which has been heated in the microwave the thermoplastic liner becomes translucent and formable. The patient centers the device over his/her lower front teeth and bites until pressure is felt on upper and lower two front teeth. Gentle pressure is applied to the ends of the GrindGuard4 for approximately 2 minutes in order to set the thermoplastic material. The rigid polysulfone outer tray helps the softer material maintain shape and conformity with the teeth while forming the device.
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K Number
K082723Device Name
GRINDGUARD
Manufacturer
GRIND GUARD TECHNOLOGIES, LLC
Date Cleared
2009-08-31
(348 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GRIND GUARD TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GrindGUARDN is a mouth guard intended to protect against grinding and clenching.
Device Description
The GrinGUARDN is an oral appliance consisting of a rigid outer tray with a dome shape protrusion in the center of the tray, to be situated over the lower incisors and an internal layer, which can be melted at low temperatures and molded to the individuals' teeth. The outer tray is manufactured from polysulfone material and the inner, moldable layer consists of polycaprolactone.
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