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510(k) Data Aggregation
K Number
K182312Device Name
Zyppah Anti-Snoring Device
Manufacturer
Always More Marketing
Date Cleared
2019-01-24
(150 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Always More Marketing
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zyppah® is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
Device Description
The Zyppah Anti-Snoring Appliance is a single piece tray system for intraoral use. The 'boil-and-bite' device is customized to each patient. It features an elastic strap that spans the device that is designed to keep the tongue in place during sleep, instead of blocking the airway and contributing to snoring. The product is non-sterile and provided in a sealed box with directions for use.
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K Number
K120371Device Name
DR GREENBURGS HYBRID ACRYLIC
Manufacturer
ALWAYS MORE MARKETING INC
Date Cleared
2012-06-27
(142 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
ALWAYS MORE MARKETING INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dr Greenburgs Hybrid Acrylic Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea
Device Description
The Dr Greenburgs Hybrid Acrylic Anti-Snoring Device is a removable intraoral device for repositioning the upper and lower jaw into a prescribed relationship for a single an resure in Creatiourgs Hybrid Anti-Snoring Device is a removable intraoral device for muliple times at home or sleep laboratories. and theming the upper and lower jaw into and one multiple times at home or sleep laboratories.
The Dr Greenburgs Hybrid Azalea
The Dr Greenburgs Hybrid Acrylin States. includes an additional elastic struction in the piece, upper and lover andem to use airway. The tray system is component which imp ind in Streamditional elastic component which impectes uper and tower arch tray system th includes an additional elastic component which impedes the tongee final into the keo ar hate an additional elastic opening and lover and lover arch tray system that airway. The tray system is a more the market becar and the back into her into her into her i the inter to increase the also whiles impedes the follows than alling back they book in the intent back back in and the may shoren than should one in only in the intent and i on alles to mercease the airway passage opening, while the addits servive back into the times back into the time the nective post into the comments. The combined effect of th
The combined effect of the advancement of the lower jaw, and the eard be may be and be from falling back into the airway reduces snoring and the target of the torgree apnea. from something back into the airway reduces snoring and the elastic impeding the airway. Them the airway reduces snoring and breathing arrests due to obstructive sleep
ing and breathing arrests due to obstructive sleep
Dr Greenburgs Hybrid Acrylic has a front area opening that is large enough for emergency
s war is large enough for emer
Dr Greenburgs Hybrid Acrylic Shoring appliance consists of two is areagnor morgency of FDA approved, well known and between the trays located posterly. The Bor 250mm 35 Hyrid Acrylic Storing appliance consists of two independent trays (Top and of From), and at elatis comected between the trays located posterior. The trays cons of For and eastic that is comments of the independent trays (Top and of FD) approved, well known andersed betrops located posterior. The trassis the gives stretur and support a sa strength and strater and longtine used onl material Ped posterior The Uner on Thop and The gires on The gires on The energer of the energer comments and corplates free. silicone. The dastic stromonolato de any to in the tongue from fallinom molar o molar o molar across the tone moredacty late Alpiedio, Mormodo do Moredo, Mormodo dio Moredo, Morano, Moremento, Alpes provence al prov ato the tongue from falling in swalling airway. The flexible of the stight of the stress the aller aller aller aller aller aller aller aller aller aller aller aller alle all of the rongue, aiding in swallowing and comfort. The flew of the field proves sight proves sight proves sight provent any tones slight provent any tonestions of the bottoms securing buttons and is locked securely between is held firm. The top tray be
Unto the bottom tray via Securely between the two trays. The top tray ho
y has a telescopic advance mechanis activated to it.
The top tray has a telescopic advances) conanism the are are mom tray via activated to its most therape moniments on the that moves forward when protuding dorsal side wings activated to its most theraped and setting. The botton side that moves forward when activated to its most the more the unsy works in syncery with the top tray via forward s article to its most therapeution on is posterior side that moves forward when when protruding dorsal side wings the upper tray morks in synergy with the born and forward t
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K Number
K120372Device Name
DR GREENBURGS HYBRID VACUUM
Manufacturer
ALWAYS MORE MARKETING INC
Date Cleared
2012-06-27
(142 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
ALWAYS MORE MARKETING INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dr Greenburgs Hybrid Vacuum Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea
Device Description
The Dr Greenburgs Hybrid Vacuum Anti-Snoring Device is a removable intraoral device for repositioning the upper and lower jaw into a prescribed relationship for a single patient multiple times at home or sleep laboratories. The Dr Greenburgs Hybrid Vacuum Device is a two piece, upper and lower arch tray system that includes an additional elastic component which impedes the tongue from falling back into the airway. The system is designed to posture the lower jaw forward with the intent to increase the airway passage opening, while the additional elastic component aids in keeping the tongue from falling back into the airway. The combined effect of the advancement of the lower jaw, and the elastic impeding the tongue from falling back into the airway reduces snoring and breathing arrests due to obstruction. Dr Greenburgs Hybrid Vacuum has a front area opening that is large enough for emergency breathing. Dr Greenburgs Hybrid Vacuum Snoring appliance consists of two independent trays (Top and Bottom), and an elastic that is connected between the trays located posteriorly. The trays consist of a clear, medical grade, copolyester that gives strength and support. The elastic consists of a non-allergenic, latex free silicone. The elastic stretches from molar to molar and is designed to impede the tongue from falling back into the airway. The flexibility of the elastic allows movement of the tongue, as well as assisting in swallowing. The elastic is held firmly onto the bottom tray via securing buttons and is locked securely between the top and bottom trays. The top and bottom trays alignment are determined by the length connecting bands that are attached via buttons on the sides of the top and bottom trays. This system moves the jaw forward to achieve the most effective position.
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K Number
K111680Device Name
DR. GREENSBURG'S HYBRID
Manufacturer
ALWAYS MORE MARKETING INC
Date Cleared
2011-12-23
(191 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
ALWAYS MORE MARKETING INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dr Greenburg's Hybrid Snoring Device is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea
Device Description
The Dr Greenburg's Hybrid Anti-Snoring Device is a removable intraoral device for repositioning the upper and lower jaw into a prescribed relationship for a single patient to use multiple times at home or sleep laboratories.
Dr Greenburg's Hybrid Anti-Snoring Device is a two piece, upper and lower arch tray system that includes an additional elastic component which impedes the tongue from falling back into the airway. The tray system is designed to posture the lower jaw into several elective positions, with the intent to increase the airway passage opening, while the additional elastic component aids in keeping the airway open by impeding the tongue from falling back and blocking the airway.
The combined effect of the advancement of the lower jaw, and the elastic impeding the tongue from falling back into the airway reduces snoring and breathing arrests due to obstructive sleep apnea.
Dr Greenburg's Hybrid has a front area opening that is large enough for emergency breathing.
Dr Greenburg's Hybrid Snoring appliance consists of two independent trays (Top and Bottom), and an elastic that is connected between the trays located posteriorly. Each tray contains a hard outer shell and a soft thermoplastic inner body. The inner body is comprised of medical grade, FDA approved Ethylene Vinyl Acetate. This thermoplastic material is the inner lining which accommodates the teeth and gives the device its characteristic "boil-&-bite" feature. The outer hard tray consists of a solid, medical grade, FDA approved Polypropylene that adds strength and structural support. The elastic consists of a non-allergenic, latex free silicone. The elastic stretches from molar to molar across the tongue. It applies slight pressure to impede the tongue from falling back into the airway. The flexibility of the elastic allows movement of the tongue, aiding in swallowing and comfort. The frictionless silicone helps to prevent any tongue irritation.
The Top and Bottom trays are locked together via a coupling protrusion mechanism. The coupling mechanism consist of buttons that are located on the lower tray and holes on the top tray. The buttons insert tightly into corresponding matching holes of the upper tray. The holes and buttons are precession made to allow the buttons to "Snap" into the corresponding holes. The strength of the polypropylene creates a tight, locking fit. The retaining elastic is held firmly on the buttons and is locked securely between the two trays via the coupling protrusion mechanism. An additional locking mechanism comes after the thermoplastic material is heated during the "Boil and Bite" phase. The thermoplastic material melts together creating a glue like structure that locks all the pieces together.
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