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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?
Product Code :
EBG
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
K243370Device Name
DentaTOOTH
Manufacturer
Asiga Pty Ltd
Date Cleared
2025-05-05
(187 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Asiga DentaTOOTH is intended exclusively for professional dental work. Asiga DentaTOOTH is a 3D print resin indicated for the manufacturing of 3D printed temporary crowns, bridges, inlays, onlays and veneers.
Device Description
DentaTOOTH is a resin material used by dental professionals for the manufacture of temporary dental restorations including temporary crowns, bridges, inlays, onlays and veneers. DentaTOOTH resin is available in six Vita shades A1, A2, A3, B1, B2, B3.
DentaTOOTH resins are used with digital light processing (DLP) based 3D printers to produce denture temporary dental restorations. DentaTOOTH resin has been validated for use with the Asiga Max Series and Pro Series printers for the manufacture of temporary dental restorations at 385nm wavelengths.
DentaTOOTH is a light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. DentaTOOTH is a Type 2, Class 2 resin per ISO 10477:2020 and Type 1, Class 2, Group 2 resin per ISO 4049:2019.
DentaTOOTH has a shelf life of 36 months. The device may be stored in Asiga Max and Pro Series printers for up to 4 weeks with hood closed.
DentaTOOTH is compliant to ISO 10477:2020 and ISO 4049:2019 for polymer based crown and veneering materials, and polymer based restorative materials, respectively.
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K Number
K243621Device Name
Evoblock, Perléon
Manufacturer
Evoden Indústria Comércio Importação e Exportação
Date Cleared
2025-04-22
(151 days)
Product Code
EBG, EBI
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indication for use:
- Temporary anterior and posterior crowns;
- Implant and abutment supported prosthetics;
- Partial, complete and hybrid denture prosthetics (base and teeth).
Device Description
Not Found
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K Number
K243951Device Name
TEMP MASTER, PMMA-based dental resin
Manufacturer
Taiwan Dental Materials CO., LTD.
Date Cleared
2025-02-21
(60 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TEMP MASTER, PMMA-based dental resin developed by Taiwan Dental Materials CO., LTD. is a self-cured resin indicated for the fabrication of short-term restorations including temporary inlays, crowns, and bridges, which can protect or restore damaged teeth while permanent restorations are being prepared. It is a traditional auto-cured PMMA-based resin composed of powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature.
Device Description
TEMP MASTER, PMMA-based dental resin, is a self-curing (cold-cure) material designed to fabricate temporary crowns and bridges. It consists of two components: powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature. Classified as a Type 1 (autopolymerizable) acrylic resin according to ISO 10477 standards, TEMP MASTER, PMMA-based dental resin provides reliable performance for temporary restorations.
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K Number
K231859Device Name
PrimmaArt
Manufacturer
DentsCare LTDA
Date Cleared
2024-11-26
(522 days)
Product Code
EBG, POW
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- Fabrication of long-lasting temporary restorations;
- Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
Device Description
Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.
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K Number
K242559Device Name
Digital Temp
Manufacturer
SprintRay Inc.
Date Cleared
2024-11-26
(90 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.
Device Description
SprintRay Digital Temp is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer of the composite material. SprintRay Digital Temp resin is offered in various shades such as Bleach, A1, A2 and B1. Digital Temp is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.
SprintRay Digital Temp resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Digital Temp resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Digital Temp file created in an optical impression system, 3D printer, and curing light equipment.
Digital Temp resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.
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K Number
K240538Device Name
Premium Teeth Resin
Manufacturer
Formlabs Ohio, Inc.
Date Cleared
2024-07-19
(144 days)
Product Code
EBG, PZY
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premium Teeth Resin, when utilized to print 3D printed dental appliances such as denture teeth for complete and partial removable dentures, try-in dentures, provisional full arch implant-supported restoration and provisional restorations such as temporary crowns and bridges, inlays, onlays and veneers, is indicated to replace or restore missing tooth structures or missing teeth.
Device Description
Formlabs Premium Teeth Resin is a light-curable polymer-based resin of 3D printed dental appliances, such as denture teeth for complete and partial res, try-in dentures, provisional full arch implant-supported restoration, and provisional restorations including temporary crowns and bridges, inlays, onlays and veneers. Formlabs Premium Teeth Resin is used to fabricate patient-specific dental appliances in a stereolithographic (SLA) 3D printer using layer additive manufacturing.
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K Number
K241226Device Name
Fixtemp® C&B 4:1
Manufacturer
Dreve Denatmid GmbH
Date Cleared
2024-05-31
(29 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.
Device Description
Fixtemp® C&B 4:1 is an automatically mixable self-curing composite, used for the direct and indirect fabrication of temporary crowns and bridges. Fixtemp C&B 4:1 is a Type 1 – polymer-based material, per ISO 10477:2020. It is available in the tooth colors A1, A2, A3, A3.5, B1 and Bleach X.
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K Number
K233868Device Name
dima Print Teeth & Temp
Manufacturer
Kulzer, LLC
Date Cleared
2024-05-23
(169 days)
Product Code
EBG, POW, PZY
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications
- Long-term temporary restorations (up to 6 months),
- Teeth for removable dentures
Device Description
dima Print Teeth & Temp is a photopolymer liquid for 3D printing of dental appliances. Its processing by dental healthcare professionals includes 3D printing, cleaning and curing. The final product produced by dental healthcare professionals will be an individual medical device for a special patient, inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted to a given denture. Dima Print Teeth & Temp is offered in a range of colors.
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K Number
K223706Device Name
PMMA BLOCK
Manufacturer
Huliang(shanghai) Bio-Tech Co., Ltd.
Date Cleared
2023-05-12
(151 days)
Product Code
EBG, EBI, MQC
Regulation Number
872.3770Why did this record match?
Product Code :
EBG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.
Indications for Use:
- Temporary anterior and posterior crowns;
- Temporary anterior and posterior bridges;
- Removable structures for dentures;
- Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
Device Description
PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.
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