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Found 8 results
510(k) Data Aggregation
K Number
K250222Device Name
SDF Pro
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2025-05-07
(100 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Product Code :
PHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SDF Pro is intended to be used by dental professionals to treat tooth hypersensitivity. For use in adults over the age of 21.
Device Description
Not Found
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K Number
K241041Device Name
Silver Fluoride Hypersensitivity Varnish
Manufacturer
Young Dental Manufacturing Co. 1, LLC
Date Cleared
2025-02-28
(318 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Product Code :
PHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults. It is intended for professional use only.
Device Description
Young Silver Fluoride Hypersensitivity Varnish is a formulation of silver, sodium fluoride, chitosan, acetic acid, and purified water intended for the treatment of dental hypersensitivity in adults. It is intended for professional use only.
Like other 510(k) cleared dental hypersensitivity varnishes including the predicate device, the proposed device works by physically occluding dentinal tubules through its silver and fluoride components. It contains small silver particles to facilitate their entry into the dentinal tubules, as well as chitosan and acetic acid to evenly disperse the solution. The product is supplied in a 10mL bottle with a dropper dispensing tip.
One to two drops of the varnish can treat up to 8 sites. If needed, a second application of the varnish may be administered after 1 week.
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K Number
K240059Device Name
FAgamin®
Manufacturer
Tedequim SRL
Date Cleared
2024-05-16
(129 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Product Code :
PHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
Device Description
FAgamin® is a professional treatment for dentin hypersensitivity. It is indicated for adults over 21 years of age.
FAgamin® is presented in a 5 ml black dropper bottle and contains a 38% w/v solution of diamine silver fluoride. Its design includes a secure screw cap and labeled container.
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K Number
K240619Device Name
e-SDF
Manufacturer
Kids-e-Dental LLP
Date Cleared
2024-03-06
(1 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Product Code :
PHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of dentinal hypersensitivity For use in adults over the age of 21.
Device Description
e-SDF is a single component liquid device made up of 38% silver diamine fluoride.Silver diamine fluoride solution is applied to the tooth, to reduce tooth sensitivity by physically occluding the open dentinal tubules. e-SDF is a liquid that is applied to the teeth using an applicator brush or similar application.
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K Number
K222459Device Name
Centrix FluoroSilver Silver Diamine Fluoride 38%
Manufacturer
Centrix Inc
Date Cleared
2023-10-27
(438 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Product Code :
PHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of Dental Hypersensitivity for use in adults over the age of 21.
Device Description
The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant. The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators and the Instructions for Use (IFU). The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
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K Number
K222323Device Name
Black Diamond
Manufacturer
Elevate Oral Care, LLC
Date Cleared
2023-06-23
(325 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Product Code :
PHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
Device Description
Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity.
The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or may not be included in the product package. These are standard items in dental offices and numerous types of each will work.
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K Number
K172047Device Name
Riva Star
Manufacturer
SDI Limited
Date Cleared
2018-04-11
(279 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Product Code :
PHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
Device Description
Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules. Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application.
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K Number
K102973Device Name
SILVER DENTAL ARREST
Manufacturer
COOLEY CONSULTING, INC.
Date Cleared
2014-07-31
(1394 days)
Product Code
PHR
Regulation Number
872.3260Why did this record match?
Product Code :
PHR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
Device Description
Not Found
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