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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.

The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices. Sterilization parameters: Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time. Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.

The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface. Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).

BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.

Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

Glidewell™ 3DP Denture Base Resin, is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. Glidewell™ 3DP Denture Base Resin, is a light-cured methacrylic material with photo initiators that form a polymer during 3D printing. Glidewell™ 3DP Denture Base Resin is printed using digital light processing (DLP). The DLP printer and resin are optimized to each other in order to achieve complete and precise printed parts. The light source provided by the DLP printer (405nm wavelength), and the post-curing light box polymerize the resin which forms a hardened denture base. Once cured, Glidewell™ 3DP Denture Base Resin has the mechanical property that meets the performance criteria for Type 4: Light-activated materials as defined in the FDA-recognized consensus standard ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers, including flexural strength, flexural modulus, water sorption and water solubility. The subject device, Glidewell™ 3DP Denture Base Resin, has the same formulation and manufacturing process as the predicate device, Glidewell™ 3DP Denture Base Resin (K213765), which contains silver sodium hydrogen zirconium phosphate. In vitro studies on the subject device, Glidewell™ 3DP Denture Base Resin, demonstrated a reduction in the following microorganisms: Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia, Candida albicans, Candida glabrata, Candida tropicalis, MRSA (Methicillin Resistant Staphylococcus aureus), VRE (Vancomycin Resistant Enterococcus).

Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Keystone® Dental PrimaConnex® Implant System, Neodent® GM Implant System, Straumann® BLX Implant System, Implant Direct® Legacy® Implant System, Implant Direct® InterActive® Implant System, Implant Direct® RePlant® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use. Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the OEM Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multiunit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

BruxZir® NOW SRC is a pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. BruxZir® NOW SRC consists of two major parts. Specifically, the precemented titanium abutment and zirconia superstructure components make up a two-piece abutment. All digitally designed CAD/CAM customizations for BruxZZir® NOW SRC are only intended to be designed and manufactured according to digital dentistry workflow, which incorporates of the digital dentistry workflow including scan files from Intra-Oral Scanners, CAD software, milling machine and associated tooling and accessories.

BruxZir® NOW SRC is a pre-manufactured two-piece hybrid abutment crown composed of a fully sintered zirconia superstructure and a pre-installed Ti-base (titanium base) that is used with the glidewell.io™ In-Office Solution. The zirconia and Ti-base components make up a two-piece abutment, which is used in conjunction with endosseous dental implants to restore chewing function. The CAD/CAM software is intended to design the final abutment shape including anatomic features and facilitate in-office milling. The Ti-base of BruxZir® NOW SRC is pre-cemented to a post-sintered zirconia superstructure, which is to be designed and fabricated to support screw-retained prosthetic restorations. After machining in the fastmill.io"M In-Office Mill, this two-piece abutment is mounted onto the implant and fixed with a screw. BruxZir® NOW SRC can be milled in-office by a dental professional and dental laboratories. The digital workflow requires the use of the following equipment: - Scanner: Intra-oral scanner - Design Software: CloudPoint FastDesign Chairside (K231529) - Restorative Material: Fully sintered zirconia; BruxZir® NOW(K220816) - Milling Unit: fastmill.io™ In-Office Mill The BruxZir® NOW SRC is designed and fabricated to be compatible with the Hahn™ Tapered Implant System (K143353) and the Inclusive® Tapered Implant System (K121406, K153099). BruxZir® NOW SRC is provided non-sterile and intended for single use and prescription use.

The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

BruxZir® Esthetic blanks are zirconia milling blanks used for the production of highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Esthetic restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Esthetic blanks are available in white, bleach, and pre-shaded varieties that can be easily adjusted to match the final shade.

The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location. Contraindication: This device is contraindicated for dental restorations greater than 3-units in length.

BruxZir® Radiant are zirconia milling blanks used to produce highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Radiant restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Radiant Blanks are available in 6 shades, Brite, White, 100, 200, 300, 400, that can be easily adjusted to match the final shade.

CloudPoint FastDesign Chairside is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. CloudPoint FastDesign Chairside is intended for use by a dental practitioner or dental laboratory staff for designing the patient-matched component of a two-piece hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant to create the final device.

CloudPoint FastDesign Chairside (also known as FastDesign), is a software suite intended to be used by trained dental practitioners or dental laboratory staff to design the patient-matched component of a two-piece hybrid dental implant abutment. A titanium base-type abutment and hybrid abutment-crown component are combined to make the two-piece hybrid dental implant abutment. The software allows a dental practitioner or dental laboratory staff to design the matching dental abutment based on imported scan data containing topographical characteristics of the patient's dentition. The resulting abutment design will be exported to a remote milling machine to make the final device. CloudPoint FastDesign Chairside, is restricted to be used with 510(k) cleared abutment systems. The software includes design parameters from the 510(k) cleared abutment systems such as maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). CloudPoint FastDesign Chairside designs the endosseous dental implant abutment under the directions of a clinical professional and maintaining accordance to the requirements of the compatible 510(k) cleared abutment systems with cleared design parameter size ranges.

Obsidian® NOW is used to fabricate ceramic dental prosthesis in the nature of crowns for posterior and anterior applications using CAD/CAM technology. The block is processed through dental laboratories or by dental professionals.

Obsidian® NOW is a fully crystallized lithium disilicate glass-ceramic block that can be milled to produce dental restorations using CAD/CAM technology. The block is intended to be used for fabricating monolithic restorations such as full contour crowns without requiring any additional crystallization prior to placement. The milling block is offered in the commonly used VITA® Classical and Chromascop® Bleach shades.