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510(k) Data Aggregation
K Number
K022627Device Name
DSG RELAXER SPLINT
Manufacturer
SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP
Date Cleared
2003-03-18
(223 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DSG Relaxer Splint is an acrylic device to be used in the treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches and relieving bruxism and temporomandibular joint syndrome through the reduction of trigeminally innervated muscular activity.
Device Description
The DSG Relaxer Splint is an acrylic device.
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