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510(k) Data Aggregation
K Number
K161716Device Name
TEETHAN 2.0
Manufacturer
BTS S.P.A.
Date Cleared
2016-12-21
(183 days)
Product Code
KZM
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
BTS S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
- To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
- To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
Device Description
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