Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K233273
    Device Name
    C&B Ceramic; C&B Permanent; C&B Interim
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2024-11-27

    (425 days)

    Product Code
    EBF, EBG
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prevest Denpro Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C&B Ceramic material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations. The C&B Permanent material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations C&B Interim material is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral lightcuring equipment.
    Device Description
    Prevest C&B, Ceramic Resin is a light-curing material with ceramic fillers used for the 3D printing/ fabrication of Ceramic Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3 /C2 /D3 /Bleach/Extra Bleach based on the shade guide. Prevest C&B, Interim resin is a light-curing material with glass fillers used for the 3D printing/ fabrication of long term temporary Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3/ C2 /D3/Bleach/Extra Bleach based on the shade guide. Prevest C&B, Permanent resin is a light-curing material with glass fillers for the 3D printing/fabrication of Permanent crown and bride dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 / A2 / A3 / A3.5 / B1 / B2 / B3 / C2 / D3/Bleach/Extra Bleach based on the shade guide. These materials are used for the additive manufacturing of crown and bridge prosthesis following the workflow as depicted below:
    Ask a Question
    K Number
    K231263
    Device Name
    Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2024-01-05

    (248 days)

    Product Code
    EBF, EBC
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prevest Denpro Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fusion Core DC Flo is indicated for use as core build up material on vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material. Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts. Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosion, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations, Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant. Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, III, IV and V, and porcelain/ composite repairs.
    Device Description
    Fusion Core DC Flo is dual-curing, radiopaque, flowable restoration for core build-up composite supplied in an auto-mix delivery system. Fusion Flo is a flowable composite of medium viscosity used for fillings in anterior teeth and small fillings in posterior teeth. Fusion Flo can be used separately or with Magma-NT composites. Fusion Flo SE is a self-etch, self-adhesive flowable composite. The flowable composite is ready for use and doesn't require the preparatory steps of etching, priming and bonding. Fusion Flo SE can be used separately or with Magma-NT composites. Fusion I-Seal is a single component, light cured flowable composite. Magma-NT is a visible light cured, radio opaque highly filled hybrid composite restorative material for anterior and posterior restoration of all teeth.
    Ask a Question
    K Number
    K231696
    Device Name
    Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2023-08-11

    (60 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prevest Denpro Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair. Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure. treatment of hypersensitive teeth, and intraoral repairs of fractured restorations. Renew Universal is indicated for direct bonding of light-cured compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured. intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.
    Device Description
    Prevest Denpro Tooth Bonding Agents attach different types of restorations to teeth. Fusion Bond 5 is a light curing single component bonding agent. It primes and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Tooth structures should have a 37% phosphoric acid etchant application of Fusion Bond 5. Fusion Bond 7 is a light curing single component bonding agent. It etches, primes, and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Fusion Bond DC is a dual cure bonding direct and indirect restorations. Enamel and dentin surfaces should be conditioned with 37% phosphoric acid etchant before application of Fusion Bond DC. It is a two component adhesive with bonding agent and activator. Renew MDP is a light curing single component bondines etching, priming and bonding in one bottle. It is an ethanol-water based dental adhesive containing 10-Methacryloyloxydececyl Dihydrogen Phosphate (10-MDP) a functional monomer which helps in bonding to dentin and cut and un-cut enamel. Renew MDP works with light-cured and dual-cured composite materials. Renew Universal is a light curing single component bondines etching, priming and bonding. Renew Universal contains a combination of functional monomers such as 10-MDP and 4-META. Renew Universal works with light-cured and dual-cured composite materials.
    Ask a Question
    K Number
    K213244
    Device Name
    Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2022-09-09

    (344 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prevest Denpro Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.
    Device Description
    Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.
    Ask a Question
    K Number
    K212563
    Device Name
    CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2022-05-23

    (283 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prevest Denpro Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points. Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification. Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials. Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling. Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating points. Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.
    Device Description
    CalApex is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is a two part, base/catalyst – paste/paste system that is mixed in equal portions. The mixture is then carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. Calplus can be used as a temporary or permanent root canal filling material. Cerafill RCS is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal. Endoseal is a Zinc Oxide/Eugenol root canal sealant. The product is made up of two separate components, a powder base and a liquid catalyst, to form the final device. Nanoseal S is a permanent root canal filling material which is silicone based (polydimethylsiloxane). It is cold flowable and is in a dual barrel cartridge. Zical Ultra Paste is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. The mixture is carried to the root canal with endodontic obturation points. The product comes in a dual barrel cartridge. Zical Ultra Powder/Liquid is a two-part, powder/liquid system for permanent filling of root canals. The mixture is carried to the root canal with endodontic obturation points.
    Ask a Question
    K Number
    K212475
    Device Name
    Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2022-05-13

    (280 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prevest Denpro Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apacal ART and is suitable for several indications including: - · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. - · Indirect pulp capping or management of deep caries lesions, or - · Direct pulp capping CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled. Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including; - · Indirect pulp capping or management of deep caries lesions, or · Direct pulp capping CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.
    Device Description
    Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips. CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips. Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips. CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.
    Ask a Question
    K Number
    K200555
    Device Name
    Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)
    Manufacturer
    Prevest Denpro Limited
    Date Cleared
    2021-05-13

    (436 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Prevest Denpro Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Micron Bioactive Class III and V. Restoration of cervical erosions and root surface caries, Core buildup. Base/Liner Class I, limited Class II, temporary fillings Restoration of primary teeth Micron Superior Shades A1. A2. A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup Micron Superior Capsules Shades A1, A2, A3 Class III, Class V, limited Class I Restoration of primary teeth, Core buildup Micron Luting Base/Liner Cementation of all types of metal, porcelain fused to metal, and resin crowns, inlays, and bridges Cementation of orthodontic bands Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns Micron Dentin Conditioner Dentin pre-treatment prior to filling with glass ionomer cement
    Device Description
    Micron Bioactive is a radiopaque, hydroxyapatite modified-glass ionomer cement. Micron Superior is a radiopaque glass ionomer cement. It comes in shades A1, A2 and A3. Micron Superior Capsules is a radiopaque glass ionomer cement. Capsules come in shades A1, A2 and A3. Micron Luting is a radiopaque, self-curing translucent, particle glass-ionomer luting material. Micron Dentin Conditioner is a mild polyacrylic acid solution designed to remove the dentinal smear layer and to condition dentine, thus enhancing the bond between glass ionomer cement and the dentine.
    Ask a Question

    Page 1 of 1