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510(k) Data Aggregation
K Number
K040315Device Name
MYOHEALTH CLENCHING INHIBITOR
Manufacturer
MCI-MYOHEALTH SYSTEMS
Date Cleared
2004-08-27
(200 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MCI-MYOHEALTH SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Protection of teeth and restorations from the forces of bruxism.
2. For the prevention of TMJ syndrome through reduction of trigeminally innervated muscular activity.
Device Description
The Myohealth Clenching Inhibitor disrupts the activity of the perieranial musculature by providing contact between the ental contact provided by this intraoral device modifies the rearward tectir. The mounted contraction of the pericranial musculature and the associated bruxism and temporal mandibular disorders.
The MCI is an anterior device custom fabricated for each patient. The Myohealth The MCI Is an amerior dories do for treating conditions diagnosed by medical professionals.
The MCI Clenching Inhibitor is designed to span 6 teeth, from upper cuspid to cuspid. The larger size of the MCI greatly reduces the risk of inhalation or swallowing this appliance. The MCI Clenching Inhibitor has a thermoplastic lining. This lining ensures excellent long term retention.
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