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510(k) Data Aggregation
K Number
K072731Device Name
ENDSNOR
Manufacturer
Date Cleared
2008-06-12
(260 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
DOCKSTADER ORTHODONTIC LAB, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EndSnor™ appliance, a dentist prescribed mandibular repositioning (MRP) device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes an EndSnor" appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis to determine the need for an EndSnor™ appliance.
Device Description
The EndSnor™ device is a dentist prescribed one-piece anti-snoring/sleep apnea appliance, custom-fit to patients' teeth by a professional dentist. It consists of an acrylic upper and lower posterior bite registration with an acrylic overlay of the posterior teeth, finished to the buccal/lingual height of contour for retention. If needed, the dentist may request stainless steel ball clasps, commonly used in the fabrication of orthodontic appliances, be added for more retention. Four expansion screws, commonly used in the fabrication of orthodontic appliances, are set in the acrylic to allow for mandibular readjustment. Mandibular adjustments are made by turning each screw equally. A labial supporting bar, commonly used in the fabrication of orthodontic appliances, is used to bridge the anterior gap in order to allow for less obstruction of the airway, and to remove the occurrence of loosening or harming of lower anterior teeth.
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