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Found 9 results
510(k) Data Aggregation
K Number
K250279Device Name
RC-SwiftPrep
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2025-07-02
(152 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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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?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
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
K240688Device Name
RODIN Titan 3D Resin
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2024-06-20
(99 days)
Product Code
EBI, EBF
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rodin Titan 3D Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, veneers and full crown restorations.
Device Description
RODIN Titan 3D Resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need. Fabrication of dental prosthetics with RODIN Titan 3D Resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment. The material is an alternative to traditional dental prostheses material Rodin Titan 3D Resin is intended exclusively for professional dental work. RODIN Titan 3D Resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
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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?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K231793Device Name
RODIN 3D Resin SPLINT, Hard/Flex
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2024-03-26
(280 days)
Product Code
MQC, KMY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RODIN Splint is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, splints and repositioners.
Device Description
Not Found
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K Number
K223365Device Name
RODIN Palette Naturalizing Kit
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2023-03-27
(144 days)
Product Code
EBD
Regulation Number
872.3310Why did this record match?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Characterization of provisionals.
Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
Characterization of C&B composite resin restorations or acrylic resin.
Device Description
Not Found
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K Number
K211420Device Name
Stasis Gel
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2022-03-14
(311 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.
Device Description
Stasis Gel is a 15.5% Ferric Sulfate in a water-based, viscous gel that facilitates sulcus retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
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K Number
K211419Device Name
Gingi-Aid Gel
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2022-01-10
(248 days)
Product Code
MVL
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GINGI-AID Gel is intended for gingival retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry when used with gingival retraction cords. The gel facilitates the insertion of the cord into the sulcus.
Device Description
Gingi-Aid Gel is a 25% Aluminum Chloride in a water-based, viscous gel that facilitates gingival retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Gingi-Aid Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
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K Number
K200462Device Name
EtchPro Etching Gel
Manufacturer
Belport Company, Inc., Gingi-Pak
Date Cleared
2020-09-02
(190 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Belport Company, Inc., Gingi-Pak
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EtchPro® Etching Gel is intended to be used by dental professionals to etch the dentin and enamel before tooth restoration treatments.
Device Description
EtchPro® Etching Gel is a 38% phosphoric acid etching gel in a soft gel form that is used by dental professionals for etching dentin and enamel before tooth restoration.
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