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510(k) Data Aggregation
K Number
K123161Device Name
SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE
Manufacturer
SMARTGUARD, INC.
Date Cleared
2013-03-14
(156 days)
Product Code
MQC, OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SMARTGUARD, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC:
- Protection against bruxism or night time teeth grinding
- Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.
Rx:
- Protection of teeth grinding, bruxism, and jaw clenching.
- Protection of restorations from injury due to bruxism or clenching.
- Relief of bruxism related headaches and pains.
- Short-term pain relief from muscle spasm due to occlusal interference; for the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
Device Description
The SmartGuard® is a dental night guard composed of Elvax and once this thermoplastic material is submerged in hot water (see molding instructions) it softens and conforms to the individual's anterior maxillary teeth from first bicuspid. SmartGuard® is designed to be worn on the anterior, upper 6 to 8 teeth, preventing the posterior teeth from coming into occlusion, which relaxes the jaw muscles and helps to reduce jaw clenching and grinding and reduces the associated symptoms. The lower bottom anterior teeth bite against the bottom of the substrate with the ability to slide around freely as the device reduces posterior teeth cuspal interferences. The design features of SmartGuard® allow patients to easily mold this device at home or in a prescribing office, to fit their teeth properly. The SmartGuard® is designed to be worn at night and not longer than 12 consecutive hours in a 24 hour period.
SmartGuard® Original and SmartGuard Elite® differ slightly in design, with the primary difference being in the width of the palatal ex-tension, (Original 21mm and Elite 30 mm) as well as the distance between the outer rim and mesial/occlusal surface of the palatal extension (Original 10 mm and Elite 9 mm). The SmartGuard Elite® was designed to fit the majority of individuals mouths. However, if the patient has a small mouth or has a sensitive gag reflex, the SmartGuard® Original might be a better fit.
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