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510(k) Data Aggregation
K Number
K163580Device Name
ASD Oral Appliances
Manufacturer
AMERICAN SLEEP DENTISTRY
Date Cleared
2017-06-08
(170 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN SLEEP DENTISTRY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.
Device Description
The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.
The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.
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