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Found 7 results
510(k) Data Aggregation
K Number
K151149Device Name
Ready-Fit
Manufacturer
DENTEK ORAL CARE, INC.
Date Cleared
2015-09-30
(153 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DENTEK ORAL CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.
Device Description
Ready-Fit Disposable Dental Guard is a ready-to-wear, posterior-only occlusive mouthquard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band.
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K Number
K130186Device Name
DENTEK EASY BRUSH WITH FLUORIDE
Manufacturer
DENTEK ORAL CARE, INC.
Date Cleared
2013-07-15
(171 days)
Product Code
EFW
Regulation Number
872.6855Why did this record match?
Applicant Name (Manufacturer) :
DENTEK ORAL CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Easy Brush with fluoride is intended to mechanically remove plaque and food particles from between teeth to reduce tooth decay. It is to be used with an in and out motion to clean between interdental space as it is done with floss, and other interdental cleaners such as tooth picks.
Device Description
The Easy Brush with fluoride is an interdental brush designed to clean between teeth. It is composed of 4 parts (a handle, a wire, bristles, and a cap). The wire is twisted around the nylon filaments to create the brush, and then is molded onto a plastic handle. It is then coated with a solution containing flavor and sodium fluoride and then capped off.
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K Number
K123849Device Name
NEW COMFORT-FIT DENTAL GUARD
Manufacturer
DENTEK ORAL CARE, INC.
Date Cleared
2013-01-10
(27 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DENTEK ORAL CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The New Comfort-Fit® Dental Guard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
Device Description
The New Comfort-Fit® Dental Guard is a posterior-only occlusion dental guard, consisting of two bite pads connected by a buccal retention strap. The New Comfort-Fit® consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to adjust to the individual user needs, with the strap always contained within the walls of the bite pads. There are 5 positions of adjustability for each bite pad. Bumpers on the lingual wall of the bite pads keep the pads from rubbing against the lower gum line. The upper vertical bite pad wall creates a greater surface area for the cheek to rest against, providing enhanced retention for the guard.
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K Number
K091660Device Name
CUSTOM COMFORT NIGHTGUARD VERSION 2
Manufacturer
DENTEK ORAL CARE, INC.
Date Cleared
2009-06-12
(3 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DENTEK ORAL CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Custom Comfort Nightguard Version 2 is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Device Description
The Custom Comfort Nightguard Version 2 is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces.
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K Number
K083400Device Name
CUSTOM COMFORT NIGHTGUARD
Manufacturer
DENTEK ORAL CARE, INC.
Date Cleared
2008-12-11
(24 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DENTEK ORAL CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Custom Comfort Nightguard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Device Description
The Custom Comfort Nightguard is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces. The Custom Comfort is designed with an anterior area formed from the soft, formable material that allows for expansion and contraction of the device to fit most mouth sizes.
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K Number
K081669Device Name
IMPROVED COMFORT-FIT NIGHTGUARD
Manufacturer
DENTEK ORAL CARE, INC.
Date Cleared
2008-07-10
(27 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DENTEK ORAL CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DenTek Improved Comfort-Fit NightGuard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
Device Description
The Improved Comfort-Fit NightGuard is a posterior-only occlusion nightguard, consisting of two bite pads connected by a buccal retention strap. The Improved Comfort-Fit consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to the individual user needs, with the strap always contained within the wings of the bite pads. There are 5 positions of adjustability for each molar pad.
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K Number
K063483Device Name
DEN TEK NIGHTGUARD
Manufacturer
DENTEK ORAL CARE, INC.
Date Cleared
2007-01-23
(67 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DENTEK ORAL CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DenTek NightGuard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding.
Device Description
The DenTek NightGuard is composed of a soft, formable material made of a blend of ethylene vinyl acetates, and non-formable occlusal base, which cushions the teeth. The base is composed of a copolymer of ethylene and methyl acrylate. When heated and then briefly cooled, the formable material is molded to fit the user's upper teeth for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces. The DenTek NightGuard is designed with three flex points that allow for expansion and contraction of the device to fit most mouth sizes.
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