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510(k) Data Aggregation
K Number
K251271Device Name
TempFIT Temporary Crown and Bridge Resin
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2025-06-23
(60 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Device Description
TempFIT Temporary Crown and Bridge Resin is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers. The mixing ratio, based on volume, base paste: catalyst paste =1:1 or 10:1. TempFIT Temporary Crown and Bridge Resin is delivered in a bio-cartridge. The curing mechanism between methacrylates is self-curing, which fundamentally belongs to free radical polymerization in reaction principle. Free radical polymerization typically occurs in unsaturated molecules containing double bonds. Both methacrylate resins in TempFIT Temporary Crown and Bridge Resin and silane coupling agents on filler surfaces contain numerous carbon-carbon unsaturated double bonds. When the two-component system is mixed, a redox reaction generates abundant free radicals that initiate the polymerization of these double bonds.
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K Number
K242530Device Name
HF-Etchant Hydrofluoric Acid Etching Gel
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2024-12-20
(116 days)
Product Code
KLE, EIH, PME
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.
Device Description
HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast. HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.
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K Number
K242572Device Name
TopCEM-Try in Veneer Try-in Gel
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2024-12-20
(113 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TopCEM-Try in Veneer Try-in Gel is used to evaluate the shade and the matching of the restoration prior to permanent cementation.
Device Description
TopCEM-Try in Veneer Try-in Gel is primarily made of polyethylene glycol, inorganic fillers and pigments. It is used to indicate the color of the Light Cure Veneer Cement before use, so as to select the right color to achieve the best aesthetic effect. The polyethylene glycol and inorganic filler in the Veneer Try-in Gel component are hydrophilic and can be rinsed off with a water gun nozzle after the color test operation. The principal organic components of TopCEM-Try in Veneer Try-in Gel are mixtures of polyethylene glycol, and the inorganic fillers loading is about 50% by volume.
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K Number
K242749Device Name
TopCEM Ceramic Primer Ceramic Coupling Agent
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2024-11-08
(57 days)
Product Code
KLE, EMA
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.
Device Description
TopCEM Ceramic Primer Ceramic Coupling Agent is common oral cementation repair auxiliary materials. In the process of using the product, TopCEM Ceramic Primer Ceramic Coupling Agent is placed between the prosthesis and resin adhesives, which can form the bonding layer of tooth tissue - light cure dental adhesive layer - resin cement layer - ceramic coupling agent - prosthesis, so as to achieve better bonding effect. TopCEM Ceramic Primer Ceramic Coupling Agent does not have direct contact with tooth tissue during use. TopCEM Ceramic Primer Ceramic Coupling Agent is mainly composed of silane coupling agent, acid acrylate and volatile organic solvent.
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K Number
K241204Device Name
TopCEM-Veneer Light Cure Veneer Cement
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2024-06-28
(59 days)
Product Code
EMA, EBF
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.
Device Description
TopCEM-Veneer Light Cure Veneer Cement is a visible light curing cementation system that is designed for use with porcelain/ceramic and composite veneer restorations. The simple and versatile shade selections allow this material to be used with a wide range of veneer cases. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBP ADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. Light Cure Veneer Cement is radiopaque, allowing for easy identification on radiographs. It is classified as Type 2 Class 2 Group 1 in accordance with ISO 4049:2019, which belongs to materials whose use requires the energy to be applied intro-orally.
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K Number
K233082Device Name
TopCEM Dual Cure Resin Cement
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2023-12-22
(87 days)
Product Code
EBF, EMA
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
· Permanent cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
· Permanent cementation for all types of root canal posts.
· Core build-ups.
Device Description
TopCEM Dual Cure Resin Cement is a versatile and ultimate dental dual cure (chemical and/or light cure) luting cement containing paste-paste of Base and Catalyst. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. It is also a core build up material in syringes. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBPADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 3 microns. TopCEM Dual Cure Resin Cement is delivered in either two separated single syringes for Hand-mix or double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A1 (Light), A2 (Medium), A3 (Dark), White Opaque) and Opaque (Universal Opaque). TopCEM Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs. It belongs to Type 2 Class 3 dual cure materials in accordance with ISO 4049. The curing mechanism of the predicate devices and subject device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.
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K Number
K230455Device Name
Enamel Coating Resin
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2023-07-25
(154 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proseal Enamel Coating Resin is a light curing material for sealing the enamel pits and fissures of teeth.
Device Description
Proseal Enamel Coating Resin is a light-curing fissure sealant and is mainly composed of methacrylate resin, photo initiator system and inorganic fillers. It is packaged in syringes or bottles.
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K Number
K221510Device Name
TrusFIL-Flow Flowable Composite Restorative
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2022-10-12
(141 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material indicated for:
- Class III and V restorations
- Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
- Base/liner under direct restorations
- Repair of small defects in indirect restorations
- Pit and fissure sealant
- Undercut blockout
- Repair of resin and acrylic temporary materials
Device Description
TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material intended to restore carious lesions or structural defects in teeth in combination of a bonding agent and with or without other materials such as luting, etching agents, cavity liners, universal composites and others commonly used in a tooth restoration. The principal organic components are mixtures of dental methacrylate resins (Bis-GMA, TEGDMA, EBPADMA). The inorganic filler loading is about 46% by volume having particle size range of about 0.01 to 3 microns. It is packaged in syringes and single-dose capsules. Single-dose delivery is intended for single patient (single use) only to prevent cross-contamination between patients.
Available shades include opaque dentin shades and regular body shades. All shades are radiopaque.
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K Number
K221450Device Name
Phosphoric Acid Etching Gel
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2022-09-12
(117 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for etching of tooth enamel and/or dentin prior to the applications of bonding direct filling, repairing or enamel surface coating materials, as well as cementations such as crowns, bridges, inlays/onlays, veneers, posts, splints, orthodontic brackets, etc. made of resin composites, porcelains/ceramics, metals and their combinations. Can also be used for cleaning of restoration surfaces prior to repairing or cementation.
Device Description
Phosphoric Acid Etching Gel is a flowable gel with excellent water solubility and miscibility. Using a disposable dispensing tip, Phosphoric Acid Etching Gel can be directly applied onto the tooth surface. Its color is blue, which can be identified easily on tooth or a repairing surface with contrast. Phosphoric Acid Etching Gel is used as an auxiliary material in the dental bonding procedure followed by the use of Light Cure Dental Adhesive.
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K Number
K202063Device Name
TrusFIL Universal Composite Restorative
Manufacturer
Rizhao HuGe Biomaterials Company, Ltd.
Date Cleared
2021-10-06
(436 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Rizhao HuGe Biomaterials Company, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TrusFIL Universal Composite Restorative is a visible light curing dental restorative material indicated for:
- Direct anterior and posterior restorations (including occlusal surfaces);
- Core Build-ups;
- Splinting:
- Indirect restorations including inlays, onlays and veneers.
Device Description
TrusFIL Universal Composite Restorative is a visible-light activated, restorative composite designed for use in anterior and posterior restorations. The principal organic components are mixtures of dental methacrylate resins (Bis-GMA, EBPADMA). The inorganic filler loading is about 54% by volume having particle size range of about 0.01 to 2 microns. It is packaged in syringes and single-dose capsules. Single-dose delivery is intended for single patient (single use) only to prevent cross-contamination between patients.
Available shades include opaque dentin shades, regular body shades and enamel shades. All shades are radiopaque.
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