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Found 4 results
510(k) Data Aggregation
K Number
K233768Device Name
Papacarie Duo
Manufacturer
Elevate Oral Care
Date Cleared
2024-07-18
(237 days)
Product Code
LBH, KLE
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
Elevate Oral Care
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.
Device Description
Papacarie Duo is a light blue colored gel cleanser dispensed from a prefilled, multi-use syringe storage system to a mixing pad, then applied to the interior of a prepared tooth cavity by dental professionals using a flocked tip brush or micro brush (not included). The tooth cavity is rinsed with water 60 seconds after application and prior to application of self-etch bonding material. The formula has a light blue color for easier visualization when it is applied on tooth surfaces. For single application prior to self-etch bonding procedure.
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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?
Applicant Name (Manufacturer) :
Elevate Oral Care, LLC
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
K150074Device Name
Elevate Moisturizing Spray
Manufacturer
ELEVATE ORAL CARE
Date Cleared
2015-06-19
(156 days)
Product Code
LFD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ELEVATE ORAL CARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Elevate Moisturizing Spray is indicated to provide comfort for individuals suffering from dry mouth. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.
- Elevate Moisturizing Spray is indicated for rapid relief of dry mouth symptoms, to provide a protective coating inside the mouth and to help control bad breath.
- A mouth spray that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.
Device Description
Elevate Moisturizing Spray is a viscous liquid dispensed from a spray bottle into the mouth. The spray will coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications.
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K Number
K131376Device Name
SMARTCOAT 2.5% NAF VARNISH
Manufacturer
ELEVATE ORAL CARE
Date Cleared
2013-08-27
(105 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
ELEVATE ORAL CARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SmartCoat 2.5% NaF Varnish is intended for use on sensitive teeth, over exposed dentin . and root surface sensitivity, and under temporary restorations or cements where post operative sensitivity is of concern.
. Rapid Desensitizer
. Provides rapid relief from sensitive teeth due hypersensitivity
Device Description
SmartCoat 2.5% NaF Varnish is classified as a Cavity Varnish (21 CFR 872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules.
SmartCoat is a topically applied, flavored cavity varnish containing sodium fluoride in a shellac resin based preparation. The varnish is an insoluble viscous liquid that dries once applied to the teeth to form a surface film. The packaging provides an accurate dosing and uniform dispensing mechanism for consistent product mixing and delivery.
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