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NizPlant Implants are a one-piece implant or two-piece assembly for single-stage surgical procedures intended for surgical implantation in edentulous or partially edentulous mandibles or maxilla for attachment of complete denture prostheses, or for fixed or removable bridgework for multi-unit tooth replacement.

NizPlant Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.

Short (<9mmL) Implants: Indicated for multiple-unit restorations of partially or fully edentulous mandibles and maxillae where vertical bone volume is limited.

The NizPlant Implants have a 2.5mmD internal hex within its most coronal portion for the insertion tool placement used in the full seating of the NizPlant Implant in the osteotomy. Implant placement, which is designed to receive multiple abutment variations, expands its restorative options allowing for the implant to be used for:
• Support of attachment-retained overdentures
• Support of screw-retained prostheses

The NizPlant Dental Implant System consists of a root form Endosseous dental implant and various other prosthetic/restorative components (medical devices) to plan, implant, and support restorations for edentulous patients.

NizPlant Implants are a one-piece implant or two-piece assembly for single-stage surgical procedures intended for surgical implantation in edentulous or partially edentulous mandibles or maxilla for attachment of complete denture prostheses, or for fixed or removable bridgework multi-unit tooth replacement.

The top one-third of the NizPlant Implant body has a straight machined neck that is placed in crestal bone. The depth gauge lines at 1mm, 2mm and 2.5mm from the top of the straight machined neck portion of the implant body facilitate the placement level with the crest of the ridge or 1mm above the crest of the ridge. Above the straight neck of the implant body is a dual-function platform which acts as an overdenture or a multi-unit abutment.

The lower two-thirds of the Implant is tapered with double-lead progressively deeper reverse buttress threads for increased bone contact. The two full-length cutting grooves are self-tapping and extend over the tapered portion of the implant's body.

The NizPlant dental implant body is available in six diameter sizes. This assortment of implants in various diameters and lengths are to be matched with an extensive componentry offering. NizPlant Implants lengths are measured from the apex of the implant to the midpoint of the gold anodized zone, that is to the base of the abutment portion of the NizPlant Implant.

NizPlant Implants have a portion of their coronal surface anodized a gold color. The gold color aids aesthetically as it is the portion that extends transmucosal from bone level, through to the oral cavity by masking of the underlying color of the non-anodized standard titanium grey. Due to its length, the 7mmL and 9mmL implants have one less circumferential groove and are replaced with an additional external thread to increase fixation within the bone.

NizPlant Implants are specifically designed with a combination of 0.5mm and/or the 1mm height circumferential grooves above the blasted implant surface (7mmL - 9mmL implant does not have the additional 0.5mm circumferential score line). These visual demarcations aid the clinician by providing the option for vertical height variability during placement. For restorations where the vertical position of the surrounding bone and/or soft tissue dictate that, part of the implant's anodized portion within the straight machined neck of the NizPlant Implant body may remain supra-crestal after placement (in addition to the 3mm prosthetic option of the dual function platform).

The NizPlant Implants are anodized a gold color with a portion of the Implant going through a surface treatment (blasting) to create a microtextured surface roughness. These implants (and the devices included in the packaging) are sold sterile. The NizPlant Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

The various devices included in the NizPlant Implant System (such as Endosseous dental implant abutments, cover screws, fixation screw, etc.) and various other prosthetic/restorative components used to plan, implant, and support restorations for fully and partially edentulous patients are offered in compatible platform dimensions to enable a complete dental restoration.

The Cover Screws are available in 5.5mm diameter with a platform diameter of 3.5mm. They are manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

The Titanium Non-Engaging Temporary Abutments are available in 5.0mm diameter with a platform diameter of 5.5mm. This is a straight configuration. They are manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant) and anodized a gold color.

The Non-Engaging Angled Screw Channel (ASC) Abutments are available in 4.7mm diameter with a platform diameter of 5.0mm and length of 0.5mm. This is a straight configuration. They are manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant) and anodized a gold color.

The Straight Multi-Unit (MUA) Abutments are available in 3.2mm diameter with a platform diameter of 4.8mm and length of 3.2mm. This is a straight configuration. They are manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant) and anodized a gold color.

The Fixations Screws are all manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

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• Bonding of indirect restorations made of composite, all-ceramic and metal.
• Bonding of prosthetic devices (crowns, inlays, onlays, bridges, and veneers) to cavities, abutment teeth, or implant abutments.
• Dental core bonding.

The subject device is a dual-cure resin cement for dental adhesion composed of two types of paste: the Catalyst Paste and the Base Paste. Each paste is filled separately in the independent double-barrel syringe and is mixed and dispensed through a dedicated mixing tip attached to the syringe nozzle. To match the color of the prepared tooth structure (dentin and enamel) and the prosthetic restoration, the Base Paste is available in four shades: Translucent, Yellow, White, and Opaque. The accessory tips include iCEM Universal Plus Mixing Tips and iCEM Universal Plus Endo Tips (consisting of Endo Mixing Tips and Extension Tips), which differ in tip diameter and are selected according to the clinical indication. All tips are single-use only. The mixed resin cement cures through both chemical and light polymerization. The subject device can adhere to tooth structure (dentin and enamel) using iCEM Universal Plus Cement, with or without the use of iCEM Universal Plus Primer, depending on the clinical indication:
• Self-Adhesive Mode: Using only iCEM Universal Plus Cement as a self-adhesive resin cement.
• Adhesive Mode: Using iCEM Universal Plus Cement in combination with the dedicated primer, iCEM Universal Plus Primer, as an adhesive resin cement.
When used in the adhesive mode, iCEM Universal Plus Primer contains a portion of the polymerization initiators involved in the chemical polymerization of the subject device. Upon contact with the subject device, these initiators are activated, initiating the polymerization of the monomers and resulting in curing. This combination enhances the bond strength to tooth structure (dentin and enamel) compared to the Self-Adhesive Mode.

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Glass Ceramic is used for the preparation of veneers, inlays, onlays, crowns, and three-unit bridges not involving molar restoration using hot press or CAD/CAM techniques.

Glass Ceramic products are grouped into two main categories: CAD/CAM Glass Ceramic and Hot Press Glass Ceramic. CAD/CAM Glass Ceramic shapes include rectangular and customized shapes, and Hot Press Glass Ceramic shapes include rectangular, cylinder, and customized shapes. Glass Ceramic is available in 33 colors, and its performance conforms to ISO 6872 Dentistry: Ceramic Materials. Glass Ceramic is composed of silicon dioxide, lithium oxide, potassium oxide, phosphorus pentoxide, aluminum oxide and other oxides. This product is for prescription use only.

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The Hushd Avera device is intended to reduce or alleviate snoring.

The Hushd Avera device is a removable intraoral non-patient specific device used for treating snoring. The device consists of multiple trays that fit over the upper and lower teeth. When the upper and lower tray engages, the device functions as a mandibular repositioner holding the mandible forward during sleep thus preventing the tongue and soft tissues of the throat from collapsing into the airway.

The Hushd Avera device is a "Boil and Bite" device where both the upper and lower trays are constructed out of moldable soft ethylene vinyl acetate (EVA) material with rigid polypropylene (PP) outer shells.

Hushd Avera consists of one upper and two lower trays. Each upper tray contains a trapezoidal block on each side of the posterior to mate with the lower tray. An identification mark is placed on the blocks. The blocks and the outer shell of the upper tray are molded in one piece.

Each lower tray contains a vertical dorsal fin on each side of the posterior to serve as mating mechanism. The fins are triangular shaped at approximately 12.0mm(H) x 12.0mm(W) x 2.5mm(D). The mating surface of the fins are flat to ensure stable positioning of the upper and lower trays against each other. An identification mark is placed on the dorsal fins. The dorsal fins and the outer shell of the lower tray are molded in one piece.

There are no additional clip-on mechanisms connecting the upper and lower trays.

Relative to the upper tray (U), the first lower tray (L1) is positioned 1.0mm forward from an edge-to-edge position, while the upper tray (U) and the second lower tray (L2) have an additional 2.0mm protrusion. The user can select between the two positions as needed.

Therefore, the maximum protrusion is +3mm from edge to edge while using L2.

There are no variants for this device and it is available only in one configuration.

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The Lifestyles® HydraFeel Natural Rubber Latex Condom is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

The LifeStyles® HydraFeel Natural Rubber Latex Condom is a single use condom made of natural rubber latex, featuring a straight-shaft, smooth-walled membrane that closely fits the penis. It acts as an barrier to prevent the transmission of sperm, bodily fluids, or STIs into the reproductive tract. The condom is coated with an aqueous lubricant and includes an integral bead at the open end for retention and a reservoir tip at the closed end to contain semen. The LifeStyles® HydraFeel Natural Rubber Latex Condom has a nominal length of 180 mm, width of 52 mm, and thickness of 0.045 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.

The device conforms with all sections of consensus standards ISO 4074:2015, Natural rubber latex male condoms – Requirements and test methods, and ASTM D3492-16, Standard Specification for Rubber Contraceptives (Male Condoms).

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The AIO Breathe is intended to reduce snoring and to treat mild and moderate obstructive sleep apnea in children 6-17 years of age who are diagnosed with snoring and/or mild or moderate obstructive sleep apnea.

AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the teeth. The device is manufactured at AIOMEGA facilities using additive manufacturing with Stereolithography (SLA) 3D printing technology that builds the device from biocompatible resins. The customized trays are fabricated based on intraoral scans provided by the dentist and the dentist's prescription.

AIO Breathe features right and left protrusive flanges on the buccal sides of the upper tray. These flanges engage with corresponding right and left vertical flanges featured on the buccal sides of the lower tray. This engagement repositions the jaw to reflect the dentist's prescribed anterior mandibular advancement.

Additionally, mandibular plateaus, as prescribed by the dentist, featured on the right, and left occlusal cranial surfaces of lower tray, guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw (jaw is not fixed in a single position) and work together to maintain advancement in open and closed mouth positions. This design feature allows more room and creates traction for the tongue to migrate forward. The resulting mechanical protrusion increases the patient's pharyngeal space, improving their ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.

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Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

Hospital size sterilizer cycles

• Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
• Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time

Tabletop sterilizer cycles:

• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time

Ethylene Oxide sterilization cycles:

• Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:

Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.

Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).

Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).

The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.

The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".

The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.

The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.

All Chex-All sterilization pouches and tubes are flat and include the following products: Chex-All Heat-seal sterilization pouch, flat; Chex-All Heat-seal sterilization tube, flat, sold in rolls; Chex-All II Self-seal sterilization pouch, flat; Chex-All III Self-seal sterilization pouch, flat.

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The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. The headcap shall be placed on the head of infants, including newborns and preterm babies.

The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device.

The Ceribell Headcap includes the following components:

• An elastic fabric headcap
• An elastic fabric chin strap
• Nine (9) silver/silver chloride (Ag/AgCl) electrodes
• A cable attached to the headcap to allow connection to an EEG acquisition/recording device

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The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.

The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.

The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.

The LumiGuide system consists of the following primary devices:

The LumiGuide Equipment R2.1 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or pre-recorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.1 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.

The LumiGuide Wire is a sterile, single use, angiographic guidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.1 using FORS technology.

The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.1 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.1 enables real time 3D visualization of the connected endovascular catheter.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The powder-free nitrile exam gloves are non-sterile, single-use, ambidextrous medical examination gloves made from nitrile butadiene rubber (NBR). They are blue, feature a beaded cuff, and are available in sizes S–XL. The gloves are not made with natural rubber latex.

Their physical and performance characteristics meet all requirements of ASTM D6319-19. The gloves are powder-free and meet the requirements of ASTM D6124-06. Powder is not used during any stage of manufacturing. Rather, the gloves are manufactured using a non-chlorinated polyurethane (PU) inner coating to reduce surface friction and facilitate donning. More specifically, following the dipping phase, the gloves pass through gelling and pre-curing ovens to stabilize the film and control thickness and tactile responsiveness. The PU coating is applied to the inner (donning) surface and then dried and cured, producing a smooth, low-friction finish. Residual processing aids are removed through rinsing/drying steps, resulting in a stable, non-reactive donning surface. Automated cuff beading is then performed to enhance edge durability and ease of application.

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