Search Results
Found 7 results
510(k) Data Aggregation
K Number
K080228Device Name
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
Manufacturer
NOVAMIN TECHNOLOGY, INC.
Date Cleared
2008-03-27
(57 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
NOVAMIN TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules
Device Description
Oralief™ OTC Toothpaste for Sensitive Teeth is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® (calcium sodium phosphosilicate) as its active ingredient. The non-aqueous formulation is designed to clean teeth as well as to physically occlude dentin tubules for the reduction of tooth sensitivity. When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
Ask a Question
K Number
K071267Device Name
PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
Manufacturer
NOVAMIN TECHNOLOGY, INC.
Date Cleared
2007-05-18
(11 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
NOVAMIN TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PerioSRP™ Tooth Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that PerioSRP™ Tooth Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
Device Description
Not Found
Ask a Question
K Number
K061359Device Name
DENSHIELD TREATMENT FOR SENSITIVE TEETH
Manufacturer
NOVAMIN TECHNOLOGY, INC.
Date Cleared
2006-10-18
(155 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
NOVAMIN TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DenShield™ is intended for the rapid and continual relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that Dentibitly is effective at occluding exposed dentinal tubules, which has been showmin the literature to be associated with a reduction in hypersensitivity.
Device Description
Not Found
Ask a Question
K Number
K040858Device Name
ORALIEF THERAPY FOR SENSITIVE TEETH
Manufacturer
NOVAMIN TECHNOLOGY, INC.
Date Cleared
2004-09-02
(153 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
NOVAMIN TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Provides rapid and continual relief from tooth hypersensitivity-dueto cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.
Device Description
Oralief™ Therapy for Sensitive Teeth incorporates NovaMin® as its active ingredient. The unique brushing regimen and NovaMin® -containing formulation provide rapid and continual relief from tooth sensitivity. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® rapidly releases mineral-building ions, allowing it to relieve from sensitivity by physically occluding dentin tubules. Within a short period of time, essentially all of the NovaMin® reacts to form a mineral layer which is chemically and structurally similar to natural tooth mineral.
Ask a Question
K Number
K041371Device Name
BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
Manufacturer
NOVAMIN TECHNOLOGY, INC.
Date Cleared
2004-08-23
(91 days)
Product Code
EJR
Regulation Number
872.6030Why did this record match?
Applicant Name (Manufacturer) :
NOVAMIN TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Butler NuCare™ Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Secondarily, Butler NuCare™ Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.
Device Description
Butler NuCare™ Prophylaxis Paste with NovaMin® is a product that is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Butler NuCare™ Prophylaxis Paste with NovaMin® is also designed to physically occlude dentinal tubules for the immediate relief of tooth sensitivity, post-scaling and root planing. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
Ask a Question
K Number
K040473Device Name
ORAVIVE TOOTH REVITALIZING PASTE
Manufacturer
NOVAMIN TECHNOLOGY, INC.
Date Cleared
2004-03-10
(15 days)
Product Code
LBH, NRE
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
NOVAMIN TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oravive™ is a fluoride-free toothpaste product intended for cleaning the tooth surface on a daily basis. Clinical studies have shown that Oravive™ also provides relief from tooth sensitivity due to cold, heat, acids, sweets, or contact by the occlusion of dentin tubules.
Device Description
Oravive™ is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® as its active ingredient. The non-aqueous formulation is designed to clean your teeth as well as give your whole mouth a fresh feeling we call REVITALIZING! Oravive™ is also designed to physically occlude dentin tubules for the management of sensitive teeth. NovaMin® (calcium sodium phosphossilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aquoous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
Ask a Question
K Number
K033295Device Name
BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
Manufacturer
NOVAMIN TECHNOLOGY, INC.
Date Cleared
2003-10-28
(14 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
NOVAMIN TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Butler Nucare® Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare® Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
Device Description
Butler Nucare® Root Conditioner with NovaMin® is a biologically-compatible device designed to condition exposed tooth roots and to physically occlude dentin tubules for the management of sensitive teeth. Butler Nucare Root Conditioner with NovaMin® is an aqueous suspension of an inorganic particulate, NovaMin® (calcium sodium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
Ask a Question
Page 1 of 1