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Flexible Partial Resin is indicated for the fabrication of dental appliances such as dental plates, bite plates, partial denture frame-works and clasps.

The subject device, Flexible Partial Resin, is a light-cured polymerizable resin for the fabrication of partial removable denture bases made in dental laboratories. The resin can be used in DLP printers utilizing a wavelength of 385nm and will be offered in G1 (standard pink), G3 (medium pink), and G4 (dark pink) shades formulated to match gingival tissue. The final medical device is a custom fitted appliance that is compliant to the dental professional's diagnosis and prescription.

Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional splints or night guards.

Partial Flex® dental resin is a polymer base material used for the fabrication of partial removable dentures and prosthesis. Partial Flex is made from a resin of polypropylene that is designed and manufactured for injection molding. Partial Flex® is available in two shades as a granular material (so-called pellets) contained in an aluminum tube with 27 g or in a plastic bag of 250 g. In addition to high biocompatibility, Partial Flex® material features hypoallergenic properties, no risk of discoloration and the dental prosthesis made are unbreakable, which differentiates the from acrylic materials. The resin material is pigmented in one color and without pigment presentation: Light pink and Natural color (without pigment).

FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.

The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients.

SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.

SprintRay Apex Flex is a photo-polymeric methacrylate/acrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to fabricate partial dentures by 3D printing layer upon layer of the composite material. The product is available in two shades: Light Pink and Standard Pink. SprintRay Apex Flex resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Apex Flex resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Apex Flex file created in an optical impression system, 3D printer, and curing light equipment. Apex Flex resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, 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.

Asiga DentaBASE is intended exclusively for professional dental work. Asiga DentaBASE is a 3D print resin intended for the manufacturing of 3D printed denture bases. The denture bases produced are suitable for dental indications including removable dentures.

Asiga DentaBASE resins are used with digital light processing (DLP) based 3D printers to produce denture bases. DentaBASE resin has been validated for use with the Asiga Max Series and Pro Series 3D printers. Asiga DentaBASE is a Type 4 light-cure methacrylate-based resin with photoinitiator, UV absorber, dispersant and pigments. Asiga DentaBASE resin material is used in a DLP 3D printer, which prints the denture base from CAD data. The denture base is built by solidifying successive layers of photopolymer against each other. Each layer is light cured before adding the next layer, with post-curing in a light chamber unit. The 3D printer and light-curing unit are not included with the device. The device is supplied as a pre-mixed resin in one color, natural pink. The device is supplied non-sterile, and it not intended to be sterilized. Asiga DentaBASE has a shelf life of 36 months. AsigaDentaBASE is compliant to ISO 20795-1 for Type 4 materials. AsigaDentaBASE is a surface device with mucosal membrane contact for >30 days and is compliant to ISO 10993-1 and ISO 7405.

Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture base Resin requires a digital denture file, 3D printer and post-curing unit.

Denture Base Resin is a liquid light-curable material. The product should be used in combination with the 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. The 3D printer and the post-curing unit of SHINING3D make use of a light source to polymerize the Denture Base Resin.

Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

Fabrication of dental prosthetics with Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment. The Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need. Denture Base resin is intended exclusively for professional dental work. Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

· Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures* and implant overdentures. · Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth. Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for use as: · Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication of the final denture.* · Printing resin for fabricating a temporary denture. · Printing resin for fabricating denture teeth in full arches and segments that will subsequently be fused into a denture base. · Printing resin for fabricating provisional crowns, bridges.** • Lucitone Digital Fuse™ Step 1 – 3D Tooth Conditioning Agent is indicated for use in enhancing the bond of denture teeth to denture base and denture base to denture base. · Lucitone Digital Fuse™ Step 2 - 3D Denture Bonding Resin is utilized as an aid in bonding denture teeth to denture base as well as repair using traditional techniques. · Lucitone Digital Fuse™ Step 3 – Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture. *Partial and full dentures are replacement for patients with missing teeth.† **For instructions on printing provisional crowns and bridges with Lucitone Digital Value reference Section G in IFU +Statement added for EU MDR alignment.

Lucitone Digital Value™ (LDV) 3D Economy Tooth & Trial Placement, which is part of the Lucitone Digital Print™ Denture (LDPD) System, is a methacrylate-based resin system which is used to fabricate dental prostheses using an additive printer and computer aided design and computer aided manufacturing (CAD/CAM) technologies.

Additively Manufactured Denture Resin is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures. Additively Manufactured Denture Resin is intended for continuous use in the oral environment, exclusively for professional dental work. Additively Manufactured Denture Resin can be used in combination with a DLP 3D printers utilizing wavelengths at 385nm or 405nm. A 3D-printer is not part of the device.

Additively Manufactured Denture Resin is a light-cured one-component materials for dental professional use only and intended for the fabrication of full and partial removable dentures. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. For use in Digital Light Processing (DLP)-3D printers utilizing wavelengths at 385nm or 405nm. The specifications of this product are divided into 500g, 1000g, 5kg and 10kg according to the weight of the resin liquid.

KeyPrint KeyDenture Base is a photopolymer resin indicated for the 3D fabrication of denture bases, including full and partial removable dentures, in dental laboratories. Fabrication requires a computer-aided design and manufacturing (CAD/CAM) system and 3D printer.

KeyPrint KeyDenture Base is designed for additive manufacturing in vat polymerization 3D printers utilizing wavelengths between 385nm-405nm. KeyDenture Base is indicated for the fabrication of oral denture appliances for fully and partially edentulous patients. KeyDenture Base is intended to be used within a computer-aided and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, and post-cure unit. For any components that are used in conjunction with the KeyDenture Base resin, the user should review all applicable product labeling including Instructions for Use, user manuals, and other associated labeling. Strict adherence to all labeling is critical in assuring a safe and effective printed appliance.