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510(k) Data Aggregation
K Number
K241071Device Name
NextDent Jet Denture Base; NextDent Jet Denture Teeth
Manufacturer
Vertex-Dental B.V.
Date Cleared
2024-09-04
(138 days)
Product Code
EBI, EBG, PZY
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Vertex-Dental B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NextDent Jet Denture Base is a light curing resin intended for 3D printing of a full or partial denture base to form a denture. The product, when used in combination with NextDent Jet Denture Teeth can be used for 3D printing a removable full or partial denture. For dental professional use only.
NextDent Jet Denture Teeth is a light curing resin intended for the 3D printing of artificial teeth to form a denture, temporary crowns or bridges. The product, when used in combination with NextDent Jet Denture Base can be used for 3D printing a removeable full or partial denture. For dental professional use only.
Device Description
NextDent Jet Denture resins are pre-mixed combinations of acrylate-based light-cure resins with pigments, polymerized via photo initiators in a 3D printer setting for the fabrication of full or partial denture bases and artificial teeth to form a denture and for the fabrication of temporary crowns or bridges. The resins must be used in combination with 3D Systems printers that support MultiJet Printing technology. Devices are produced in an automated additive manufacturing method where ultra-thin layers of photopolymer material are jetted onto a build tray. Immediately after being jetted, each photopolymer layer is cured by UV light. The process repeats layer by layer until the 3D part is complete. Upon completion the support material is removed, and the product is cleaned. When printing a denture base, bonding of artificial teeth to the denture base is possible to form a denture. The bonding agent instructions should be followed. Printed parts are finished using conventional dental methods and instruments.
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K Number
K231388Device Name
NextDent Base
Manufacturer
Vertex-Dental B.V.
Date Cleared
2023-10-20
(161 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Vertex-Dental B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NextDent Base is for dental professional use only and intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures.
Device Description
Light-Cure Resin, provided in a container. NextDent Base is a combination of acrylate-based light-cure resin with pigments, polymerized via photo initiators in a 3D printer setting for fabrication of denture bases to support artificial teeth to form full or partial removable dentures. Fabrication of denture bases with NextDent Base requires a VAT based 3D printer that supports NextDent resins. Printer and resin must be optimized to each other to get complete and precise printed parts.
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K Number
K123220Device Name
VERTEX THERMOSENS RIGID
Manufacturer
VERTEX-DENTAL B.V.
Date Cleared
2013-03-01
(137 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
VERTEX-DENTAL B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vertex™ ThermoSens is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments.
Device Description
Vertex™ ThermoSens Rigid is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments. The Vertex™ ThermoSens material is incorporated in an aluminium tube, which is heated up to 280 degrees Celsius. After a heating period of 18 minutes, the material is injected into the flask by pressure. The technique can be done in an automatic injection machine or manually. The preparations of the model and flask are according to standard procedures of the dental technique. An instruction for use is in writing, film and pictures available. Also a course can be taken to learn the technique and work with the product.
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K Number
K102640Device Name
VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
Manufacturer
VERTEX-DENTAL B.V.
Date Cleared
2011-03-25
(192 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
VERTEX-DENTAL B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vertex cold-curing denture base materials are indicated for:
- Manufacture of full and partial dentures
- Repair of full and partial dentures
- Rebasing of full and partial dentures
- Relining of full and partial dentures
Device Description
Vertex cold-curing denture base materials are self curing acrylic denture base materials composed of polymethyl methacrylate powder and a liquid consisting of methyl methacrylate and other ingredients. The polymer is shaded to simulate the color of gum tissue using pigments that are approved for alimentary or similar use and are Cadmium free. The devices covered in this submission are the Vertex Self Curing, Vertex Castavaria, and the Vertex Castapress denture base materials.
VertexTM Self Curing is a self-curing acrylic denture base material intended for the repair and relining of full and partial dentures, made by heat-curing acrylics. This acrylic can be polymerized in 10 minutes using a pressure vessel.
VertexTM Castavaria is a multifunctional self polymerizing denture base material intended as a pouring and as a repair acrylic. The advantages of this acrylic are: minimized shrinkage, color stability, stable polymerization cycle and the acrylic is pourable for a long period of time. In addition Vertex™ Castavaria can be worked and modeled over a relatively long period of time.
Vertex™ Castapress is a self polymerizing pouring/casting type denture base material also suitable for repair, relining, rebasing and extensions of partial dentures. The colour stability of the material is excellent because of the use of an unique accelerator system
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K Number
K102654Device Name
VERTEX RAPID SIMPLIFIED
Manufacturer
VERTEX-DENTAL B.V.
Date Cleared
2010-12-03
(80 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
VERTEX-DENTAL B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vertex Rapid Simplified is indicated for: 1. Fabrication of full dentures 2. Fabrication of partial dentures
Device Description
The Vertex hot-curing denture base material is a conventional dough pack heat cured denture base material that consists of polymethyl methacrylate powder with a heat cure monomer consisting of methyl methacrylate. This material complies with the requirements of ISO 1567, Dentistry. Denture base polymers. The pressing technique is the processing method for Vertex hot-curing denture base material. This cadmium-free acrylic has a rapid 20 minutes polymerization cycle (overnight polymerization is also possible). The Vertex hot-curing denture base powder is available in 10 shades.
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