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510(k) Data Aggregation
K Number
K243777Device Name
Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
Manufacturer
Theodent, LLC
Date Cleared
2025-05-27
(169 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rennou™ Varnish is indicated for the relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules.
Device Description
Rennou™ Varnish is a cavity varnish intended for professional use as a topical application on prepared tooth surfaces. This fluoride-free varnish creates a rosin-based film that prevents penetration of restorative material into the dentinal tissue and provides relief of tooth hypersensitivity by occluding open dentinal tubules. Unit-dose varnish and applicator are packaged together in individual thin, sealed trays. Rennou™ Varnish is only applied by a professional clinician.
Rennou™ Varnish is a topically applied flavored (Spearmint, etc.) compound comprised of natural rosin, ethanol, xylitol, and Rennou™ (a combination of theobromine, calcium acetate, and sodium hydrogen phosphate). The major components are rosin and ethanol, which, when delivered together, efficiently promote a fast-drying film on the tooth surface. The varnish is sweetened with xylitol.
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K Number
K241489Device Name
ReminGel
Manufacturer
Inter-Med, Inc.
Date Cleared
2025-01-08
(229 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.
Device Description
ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. ReminGel blocks nerve excitability through potassium release. ReminGel is packaged in a 3oz (90mL) tube. ReminGel is for prescription use (Rx) and over-the-counter (OTC) use. ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush.
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K Number
K241568Device Name
CrystLCare PRO Biorestorative, Fluoride-Plus
Manufacturer
GreenMark Biomedical Inc.
Date Cleared
2025-01-02
(216 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for relief of discomfort from dentin sensitivity.
Device Description
CrystLCare™ PRO Biorestorative, Fluoride-Plus is a flavored dental strip which contains calcium, phosphate, and fluoride which are stabilized with a modified starch. The single-use strip is topically applied to the outer surface of a tooth or teeth that are experiencing dental sensitivity. The strip dissolves in salivator elease these minerals which then will precipitate crystals that form a layer over the tooth surfaces. This physically occludes exposed dentinal tubules and enamel porosities to relieve discomfort. The modified starch helps to stabilize the calcium, phosphate, and fluoride mineral components so that they can persity into the dentinal tubules.
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K Number
K242913Device Name
Jasmate® Toothpaste
Manufacturer
Jasberry Healthcare Private Limited
Date Cleared
2024-11-22
(59 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Jasmate® Toothpaste is prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
Device Description
Jasmate® toothpaste is a dentist and dental professional prescribed, daily-use, fluoride dentifrice to be used in the prevention and treatment of dental sensitivity through the physical occlusion of dentin tubules.
Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are needed for mineralization. This makes the teeth more resistant to demineralization by changing the apatite crystal solubility. Sodium fluoride inhibits the demineralization of teeth in a pH-related manner. Sodium fluoride and hydroxyapatite are active ingredients. When exposed environment, it undergoes a rapid surface reaction to form fluorapatite, which is chemically and structurally similar to natural tooth mineral, allowing it to physically occlude tubules.
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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?
Product Code :
LBH
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
K231060Device Name
ProMin Dental Desensitizing Gel
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2024-06-13
(427 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K230333Device Name
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
Manufacturer
Kettenbach GmbH & Co. KG
Date Cleared
2023-07-24
(167 days)
Product Code
LBH, PRO
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Device Description
Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored.
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K Number
K222891Device Name
Dental Desensitizer
Manufacturer
Guangzhou Beogene Biotech Co., Ltd
Date Cleared
2023-05-25
(244 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dental Desensitizer is a colorless transparent gel that is applied to the sensitive part of the tooth to form a film, sealing the exposed dentin tubules and relieving dentin allergy. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.
Device Description
Dental Desensitizer is a sustained release, 3% potassium nitrate and 0.11% weight fluoride ion, viscous gel. This product is designed to be used together with a custom-fabricated tray.
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K Number
K231338Device Name
3M Clinpro Clear 2.1% Sodium Fluoride Treatment
Manufacturer
3M ESPE Dental Products
Date Cleared
2023-05-10
(2 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.
Device Description
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is an aqueous fluoride coating that is applied topically to the tooth surfaces for the treatment of hypersensitive teeth. The product is sweetened with xylitol and sucralose. Clinpro 2.1% Sodium Fluoride Treatment contains 9,500 ppm fluoride and added calcium and phosphate. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment uses the L-Pop™ unit dose dispensing system designed by 3M. Each L-Pop contains 0.5 ml (0.5 grams) of the coating and is offered in mint and melon flavors and a flavorless version.
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K Number
K220419Device Name
Apapro Desensitizer
Manufacturer
Sangi Co, Ltd
Date Cleared
2022-02-16
(2 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Product Code :
LBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
APAPRO Desensitizer is a fluoride-free paste that is indicated to provide relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.
Device Description
APAPRO Desensitizer is a fluoride-free tooth desensitizing paste that utilizes hydroxyapatite, the main component of teeth, as its active ingredient to relieve tooth sensitivity by physically occluding exposed dentin tubules. The hydroxyapatite deposited into dentin tubules by APAPRO Desensitizer then acts as a template for the further deposition of large amounts of calcium and phosphate ions, promoting crystal integrity and growth.
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