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510(k) Data Aggregation
K Number
K203462Device Name
Advanced Dental Appliance
Manufacturer
Date Cleared
2021-02-19
(87 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
DaSoft Partners
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients age 18 years or older.
Device Description
The DaSoft Advanced Dental Appliance, previously cleared under K172991, repositions the tongue and related tissues anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence; a causative factor in snoring. The device is manufactured using medical grade ethylene vinyl acetate (EVA) polymer, which is a material that has a "generally recognized as safe" (GRAS) designation from FDA.
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K Number
K172991Device Name
Advanced Dental Applicance
Manufacturer
Date Cleared
2018-07-10
(286 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
DaSoft Partners
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients aged 18 years or older.
Device Description
The DaSoft Advanced Dental Appliance is an intraoral device designed to be worn during sleep to reduce snoring. The device includes a manually adjustable tongue sleeve to position the tongue and surrounding tissues forward in order to increase the patient's pharyngeal space, improving the ability to exchange air and decreases air turbulence. The device is manufactured using only medical grade ethylene vinyl acetate (EVA) polymer.
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