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510(k) Data Aggregation
K Number
K233754Device Name
AIO Breathe
Manufacturer
Aiomega, LLC
Date Cleared
2024-02-23
(93 days)
Product Code
LQZ, LOZ, LRK
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
Device Description
AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the teeth. The device is manufactured at AIOMEGA facilities using additive manufacturing with Stereolithography (SLA) 3D printing technology that builds the device from biocompatible resins. The customized trays are fabricated based on intraoral scans provided by the dentist and the dentist's prescription.
AIO Breathe features right and left protrusive flanges on the buccal sides of the upper tray. These flanges engage with corresponding right and left vertical flanges featured on the buccal sides of the lower tray. This engagement repositions the jaw to reflect the dentist's prescribed anterior mandibular advancement.
Additionally, mandibular plateaus, as prescribed by the dentist, featured on the right, and left occlusal cranial surfaces of lower tray, guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw (jaw is not fixed in a single position) and work together to maintain advancement in open and closed mouth positions. This design feature allows more room and creates traction for the tongue to migrate forward. The resulting mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.
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K Number
K230532Device Name
RADx Intraoral Appliance for Snoring and Sleep Apnea
Manufacturer
Achaemenid LLC
Date Cleared
2023-07-12
(135 days)
Product Code
LQZ, LRK
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
Device Description
The RADx White Night and RADx White Night-p Intraoral Appliance for Snoring and Mild to Moderate Sleep Apnea are removable intraoral devices used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated adjustable rods that fit separately over the upper and lower teeth. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is a prescription device customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the user and / or the dentist in increments of 0.5 mm.
The custom oral appliance is checked for proper and comfortable fit as well as the appropriate initial progressive arm attachment. The dentist will provide the patient with subsequent progressive arms from 1.0 mm up to 5.0mm in 0.5mm increments.
There are 9 different arms each identified with a number for each side of the jaw. The arms are also identified as either "L" for left or "R" for right.
Variants / Configurations
There are two variants of the device.
The RADx White Night has removable progressive arms with the female housing active as the receptacle for the arms.
The RADx White Night-p was designed with the upper housing and arm as one piece. In this version, the fixed upper tray-arm combination are the progressive parts of the entire apparatus.
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K Number
K203712Device Name
The Slide
Manufacturer
Biotex, Inc.
Date Cleared
2021-07-20
(211 days)
Product Code
LQZ, LRK
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Slide is for use to reduce night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Slide™ is a prescribed intraoral device worn while sleeping in order to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA). Snoring and OSA is caused by partial or complete closure of the muscle in the upper airway (pharyngeal space). The device uses two splints joined by two parallel sliding connectors that position the lower iaw forward and open from its normal location. This forward protrusion opens up the upper airway reducing obstructions during sleep. The prescribing dentist determines the exact repositioning of the lower bite. Its simplistic design allows for the forward displacement to be adjusted without the use of specialized tools using different sized spacers. Adjustments are initially made in the prescribing dentist office; further adjustments can be made depending on relief of symptoms and comfort while sleeping.
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K Number
K191320Device Name
Slow Wave DS8
Manufacturer
Slow Wave, Inc.
Date Cleared
2020-10-02
(506 days)
Product Code
LQZ, LRK
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
Device Description
DS8 consists of two trays worn on the maxilla and mandible. The device is manufactured at Slow Wave facilities using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.
The trays are designed to be an exact custom fit by a trained dental technician, using a 3Shape intraoral scanning device, or comparable intraoral scanner such as the iTero, or Cerec, registering one's full impressions of the upper teeth, lower teeth. A bite scan registration with a gap (typically 8 mm), which is a crucial design feature. The gap results from the design of the lower and upper trays. The upper and lower trays, the molars, premolars, and canines, are covered by the device. However, the lateral or central incisors are not covered, which effectively leaves eight teeth (four maxillary incisors and four mandibular incisors) uncovered. The trays are shaped like arch because the covered portion of the device is connected to each other by two palatal bands one connecting the upper left and upper tray, and the other connecting the lower tray.
Additionally, the trays are built with ramps that guide the mandible forward and downward, thus maintaining advancement, enlarging the airway, allowing more room for the tongue to migrate forward naturally. The vertical opening of the jaw is not fixed in a single position. DS8 is a traction-based mandibular repositioning device that allows nasal and/or oral breathing.
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K Number
K192581Device Name
The NightBlocks Appliance
Manufacturer
Advanced Facialdontics LLC
Date Cleared
2020-01-28
(131 days)
Product Code
LQZ, LOZ, LRK
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NightBlocks™ Appliance is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The NightBlocks™ Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
Device Description
The NightBlocks™ appliance consist of two removable, custom fabricated acrylic trays that fit separately over the upper and lower dental arches and engage each other in order to reposition the mandible in a slightly anterior position. They contain stainlesssteel ball clasps for extra retention and stainless-steel orthodontic expansion screws on the buccal portion of the upper tray that engage with the dorsal wings of the lower tray. The trays occlude on the left or right molar and premolar region. Every device is custom prescribed and fabricated for each patient from dental models and is adjustable at the time of delivery and anytime thereafter as it is intended to be used in the home setting.
The principal of operation is jaw repositioning. Worn during sleep, the NightBlocks™ function as a mandibular advancement device which acts to increase the patient's pharyngeal airway space, improving their ability to exchange air during sleep. The anterior repositioning of the mandible prevents the tongue from sliding backward or downward for a prone sleeping individual. Therefore, the airway will be larger, contributing to the reduction in snoring and mild to moderate sleep apnea.
Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).
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K Number
K162816Device Name
SML-OSA2 Appliances
Manufacturer
SELANE PRODUCTS, INC.
Date Cleared
2017-07-27
(294 days)
Product Code
LQZ, LRK
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SML OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
Device Description
The SML-OSA2 APPLIANCES include five device models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA) and V-force.
The SML-OSA2 Appliances are customized, intraoral dental devices designed to reduce snoring and mild to moderate obstructive sleep apnea in adults. The devices fit over the dentition and reposition the mandible in a slightly protrusive position. The SML-OSA2 APPLIANCES consist of 2 arch forms that are linked to advance the mandible, and are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
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K Number
K130130Device Name
ATG/SM-OSA APPLIANCES
Manufacturer
SELANE PRODUCTS, INC.
Date Cleared
2013-08-26
(221 days)
Product Code
LQZ, LOZ, LRK
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATG/SM-OSA appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The ATG/SM-OSA appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
Device Description
The ATG/SM-OSA APPLIANCES are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Three designs are included: Adjustable Herbst, Adjustable Dorsal, and MIRS. The mandible protrusion is controlled by stainless steel tubes & rods or screws for the Herbst and Dorsal designs. The MIRS single-piece construction has a lingual rest to set the mandibular protrusion. Each device is fabricated to the prescription of a dentist.
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K Number
K112627Device Name
MILLENIUM ANTI-SNORING DEVICE
Manufacturer
MILLENIUM DENTAL LABORATORY, INC
Date Cleared
2012-06-06
(271 days)
Product Code
LQZ
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Millenium Anti-Snoring Device is indicated for use in the treatment of snoring and mild to moderate obstructive sleep apnea in adult patients.
Device Description
Not Found
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K Number
K112766Device Name
SNORKEL
Manufacturer
FELLMAR COMPANY
Date Cleared
2012-06-04
(256 days)
Product Code
LQZ
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.
Device Description
The Snorkel is an oral mandibular advancement device whose function is to artificially protrude the chin (mandible) forward so as to pull the tongue away from the back of the throat, thereby reducing tongue-induced airway obstruction.
The Snorkel device is custom-made and fitted based on dental impressions and used by the patient during sleep. The single mouth piece fits snugly onto the upper and lower crowns of the patient's teeth. As the patient falls asleep, thus relaxing their mandible, a silicon band provides tension such that the mandible is pulled forward along with the tongue.
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K Number
K113201Device Name
NARVAL CC
Manufacturer
RESMED SAS
Date Cleared
2011-12-01
(31 days)
Product Code
LQZ
Regulation Number
872.5570Why did this record match?
Product Code :
LQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Narval CC™ is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Narval CC is a removable intraoral device used for treating snoring and sleep apnea. It consist of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving his/her ability to exchange air and reducing the tendency to snore. The device is custom made for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting.
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