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510(k) Data Aggregation
K Number
K023836Device Name
THE SUAD DEVICE
Manufacturer
STRONG DENTAL INC.
Date Cleared
2003-07-08
(232 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
STRONG DENTAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A custom-fitted mandibular repositioning device intended to reduce or alleviate nighttimc snoring and obstructive slocp apnca.
Device Description
The SUAD™ Device is a custom-fitted mandibular device that allows patients to move their jaw laterally and vertically without disengaging the appliance. The device is adjusted to provide the anticipated relief of the condition by moving the mandible forward in 1mm increments by adding advancement shims onto the posts. The SUAD™ Device has modifications in the combination of materials used, the assembly, and the fabrication technique compared to the predicate device. The casted framework is substantially equivalent to casted frameworks used in dentures prior to 1976. The "tube and rod" assembly of the pivot and tube is substantially equivalent to the Herbst appliance, with a changed angle of the connecting tube to the pivot for greater stability. The framework strengthens the device. Smooth "buttons," frames covering all occlusal and incisal surfaces, and the use of vacuum-formed thermo-plastic result in less exposed wires.
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