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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
DentsCare LTDA
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
K232994Device Name
Vittra APS Unique Flow
Manufacturer
Dentscare LTDA
Date Cleared
2024-10-18
(392 days)
Product Code
EBF, EBC
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Dentscare LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Base under direct restorations;
- Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy;
- Pit and fissure sealant;
- Tunnel-type preparation;
- Repair of small enamel defects;
- Bonding of tooth fragments;
- Composite resin repairs;
- Non-carious cervical lesions.
Device Description
Vittra APS Unique Flow is a light-curing composite of low viscosity, with a single shade for all dental shades, suitable for minimally invasive cavity preparations, base/liner and minor repairs. The composite is radiopaque, with a total inorganic filler content of 58% to 62% by weight (56% to 60% by volume) and an average particle size between 1.7 and 1.9 micrometers. It does not contain Bis-GMA or Bis-EMA in its formulation, following the current trend of Bisphenol A (BPA) free products. The composite has the APS as a photoinitiator system, an acronym for Advanced Polymerization System, which consists of a combination of different photoinitiators that interact with each other, amplifying the curing capacity of the light emitted by the light-curing units. Added to different materials, the system provides several advantages. APS confers great polymerization power, which allows a greater degree of conversion, obtaining superior stability to ambient light and providing longer working time during restorations.
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K Number
K210231Device Name
Vittra APS Unique
Manufacturer
Dentscare Ltda
Date Cleared
2021-10-14
(259 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Dentscare Ltda
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vittra APS Unique composite is indicated for use in permanent and deciduous teeth:
- Direct restorations in anterior and posterior teeth (Classes I, II, III, IV, V and VI).
Device Description
Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The composite is radiopaque, with total inorganic load of 72% to 80% in weight (52% to 60% in volume), average particles between 0.8 and 0.9 microns. It does not contain Bis-GMA nor Bis-EMA in its formula, following the present trend of products not made with Bisphenol A (BPA).
The composite has APS as its photoinitiation system. APS stands for Advanced Polymerization System, and consists of a combination of different photoinitiators that interact among themselves amplifying the curing capacity of the light emitted by the light-curing device.
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K Number
K201707Device Name
Opallis, Opallis Flow
Manufacturer
Dentscare LTDA
Date Cleared
2020-12-22
(183 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Dentscare LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opallis (Sculptable version)
- The composite is suitable for use in permanent and deciduous teeth:
- Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI.
- Direct veneers with composites.
- Cementation of tooth fragments.
- Core build-ups.
- Teeth splinting.
- Diastema closing or reduction.
- Modification of teeth's shape (e.g .: conoid teeth).
- Porcelain/composite repairs.
Opallis Flow (Flowable version)
- Base/lining underneath direct restorations.
- Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy
- Pit and fissure sealant.
- Tunnel-type preparation.
- Repair of enamel defects.
- Bonding of tooth fragments.
- Repairs in composite resin.
- Non-carious cervical lesions.
- Planning of preparation walls.
Device Description
Opallis is a, radiopaque, light-curing composite resin with fluorescent and opalescent properties. It is an aesthetic restorative material used for restorations of anterior and posterior teeth.
Opallis Flow is a light-curing composite resin used for the restoration of slightly invasive preparations, pit and fissure sealant, base/lining underneath direct restorations, in tunnel-type preparations, radiopaque lining of cavities, repairs of enamel defects, restorations of primary teeth, repairs in composite resin, bonding of tooth fragments, class I, III and V restorations, non-carious cervical lesions. Opallis Flow can be used separately or with Opallis composites.
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K Number
K192682Device Name
Orthocem, Ortho Bite
Manufacturer
Dentscare Ltda
Date Cleared
2020-08-14
(323 days)
Product Code
DYH, EBF
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
Dentscare Ltda
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthocem: Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface.
Ortho bite: The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment.
Device Description
Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product's removal from teeth, after removing brackets.
Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. Its composition includes dimethacrylate monomers, HEMA Phosphate, traditional Camphorquinone/DABE system as photoinitiator and silica as load particle. The combination of silica load fillers with the dimethacrylate monomer composition results in a viscosity that allows it to be handled and applied without running off the application area. The presence of HEMA Phosphate allows adhesion to the enamel surface, which is a known feature of composite cements indicated for bracket bonding. The thixotropy allows the product to have self-levelling capability, known as a shear thinning property that makes the composite settle correctly on the occlusal surface. The product is colored in order to facilitate its identification during application and removal.
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K Number
K191389Device Name
Allcem Veneer APS
Manufacturer
Dentscare Ltda
Date Cleared
2020-02-25
(277 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Dentscare Ltda
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Allcem Veneer APS is an adhesive luting of ceramic and composite restorations (fabricated at the chair-side or in the laboratory) with a low layer thickness (up to 1.5 mm) that enable the use of a purely light-curing technique due to their high translucency.
Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement.
Device Description
Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thickness, that do not have opaque infrastructure. The cement is presented as a single component (single svringe) and must be used according to the adhesive cementation technique (acid etching + adhesive).
APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photo initiators that interact among each other amplifying the curing capacity of light emitted from light-curing units.
Presentation Form:
- syringe (2,5g) of Allcem Veneer APS cement in shade A1
- syringe (2,5q) of Allcem Veneer APS cement in shade A2
- syringe (2,5g) of Allcem Veneer APS cement in shade A3
- syringe (2,5q) of Allcem Veneer APS cement in shade Trans (Translucent)
- syringe (2,5q) of Allcem Veneer APS cement in shade Opaque
- syringe (2,5q) of Allcem Veneer APS cement in shade White
- syringe (2,5q) of Allcem Veneer APS cement in shades E-Bleach M
- syringes (2g) of Try-in
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K Number
K191306Device Name
Llis, Vittra APS
Manufacturer
Dentscare LTDA
Date Cleared
2019-12-16
(216 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Dentscare LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Llis and VITTRA APS composite is suitable for use in:
- Direct restorations in anterior and posterior teeth (I, II, III, IV, V e VI);
- Core build-ups;
- Teeth splinting;
- Indirect restorations such as inlays, onlays and veneers.
- Direct veneers with composites;
- Restoration of deciduous teeth
- Diastema closing or reduction;
- Modification of teeth's shape (e.g .: conoid teeth);
- Cementation of tooth fragments;
- Porcelain/composite repairs:
Device Description
Llis is a radiopaque composite for anterior and posterior restorations. Its composition was based in modern concepts so that methacrylate monomers, silanes and fillers with adequate size distribution were combined to produce a product with differentiated physical, mechanical and optical properties. Llis presents a simplified shade system, offering enamel, dentin and incisal shades.
Vittra APS is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth. The composite is radiopaque; its loading particles are composed by spheres of a zirconia complex with average load particle size of 200nm, with total inorganic load of 72% to 82% in weight (52% to 60% in volume). Those characteristics contribute to enhance both mechanical and aesthetic properties, especially evidenced by how easy it is to obtain proper polishing and by the long-lasting surface shining. Vittra APS' formula is free of Bis-GMA and Bis-EMA, following the present trend of products free of Bisphenol A (BPA).
APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photoinitiators that interact among each other amplifying the curing capacity of light emitted from light-curing units. Added to different materials, the system provides different advantages.
In the case of Vittra APS, APS adds as main benefit the reduction or elimination of visual shade and opacity alteration before/after light curing, which enhances the predictability of the result. Another factor is that, although there is very little concentration of camphorquinone - that has a yellowish aspect - APS has great power of polymerization allowing greater degree of conversion. The APS system is activated by any type of lightcuring unit available on the market, even those with less power or narrow range of wavelength.
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K Number
K183424Device Name
Ambar, Ambar APS, Ambar Universal APS
Manufacturer
DentsCare LTDA
Date Cleared
2019-12-13
(367 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
DentsCare LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- All classes of direct restoration with composites (class I, II, III, IV and V);
- Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
- Adhesive repairs in ceramic and composites.
*Only for Ambar Universal APS: Use as metallic or ceramic primer.
Device Description
Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.
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K Number
K183465Device Name
Allcem, Allcem Core
Manufacturer
Dentscare LTDA
Date Cleared
2019-11-02
(323 days)
Product Code
EMA, EBF
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
Dentscare LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Allcem and Allcem Core are indicated for the cementation of the tooth structure. It can be used for luting:
- · Porcelain fused-to-metal crowns and bridges;
- · Metal crowns, bridges, inlays and onlays (high noble, noble, and base metals);
- · Crowns and bridges with minimal tooth structure;
- · Maryland bridges (resin bonded bridges);
- · All ceramic/porcelain and pre-cured composite crowns, bridges, inlays and onlays;
- · Endodontic posts;
- * Only for Allcem Core: Core build-up.
Device Description
ALLCEM: Allcem is a dual-curing radiopaque permanent resin cement system indicated for the cementation of indirect restorations to the tooth structure. The product is composed of a base paste and a catalyst paste, stored in a double-body syringe, which allows releasinq the correct proportion of each paste (1:1) and separating syringes of base paste and catalyst paste. Allcem is composed of methacrylate monomers, such as TEGDMA and BisEMA, inorganic load, photoinitiators, coinitiators, catalysts and pigments. Allcem presents adjusted viscosity allowing the formation of fine layers of cement with the appropriate covering of the parts.
ALLCEM CORE: Allcem Core is a dual-curing resin cement specially conceived for the adhesive cementation of intraradicular posts, crowns and core build-up . The product is commercialized in a double-body syringe, which facilitates obtaining the correct mixing proportions of the two pastes (1:1), and eases clinical procedures. By using an self-mixing tip with an applying nozzle (intracanal tip), it is possible to apply the cement inside the root canal and easily cement the post. The same tip can be used to add material to the crown region of the post to build up the core, Allcem Core is a composite of methacrylate monomers such as BisGMA, BisEMA and TEGDMA, inorqanic load, photoinitiators, coinitiators, catalysts and pigments. The cement associates the necessary flow for applications in canals with the ideal thixotropy for core build-ups.
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K Number
K190758Device Name
Opus Bulk Fill APS, Opus Bulk Fill Flow APS
Manufacturer
DentsCare LTDA
Date Cleared
2019-09-04
(163 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DentsCare LTDA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Opus Bulk Fill APS
- Direct restorations in posterior teeth (permanent and deciduous) in increments of up to 5mm, including the occlusal surface;
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Reconstructive build-up;-
- Base and lining of direct restorations;
- Repair of small defects of the enamel;
- Repair of temporary acrylic and resin materials
Opus Bulk Fill Flow APS
- Base/lining underneath direct restorations.
- Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy
- Pit and fissure sealant
- Tunnel-type preparation.
- Repair of enamel defects
- Bonding of tooth fragments.
- Repair in composite resin
- Non-carious cervical lesions.
- Planning of preparation walls.
- Core build-up
Device Description
Opus Bulk Fill APS is a light-curing composite recommended for restorations performed in large increments. The technical characteristics of the product allow the professional to use increments of up to 5mm in the cavities, including the occlusal surface (it does not require an additional capping layer). The composite has approximately 79% of load filler (in mass). APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photo initiators that interact among each other amplifying the curing capacity of light emitted from light-curing units.
Opus Bulk Fill Flow is a bulk-fill flowable light-curing composite (fluid) recommended to be used as base and lining of restorations on posterior teeth. That feature associated to its cure depth – due to the composite's translucency – allows Opus Bulk Fill Flow to be applied in increments of up to 4mm, reducing the time for restoring large cavities.
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