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Permanent obturation of root canals of the secondary dentition in combination with root canal points.

AH Plus Endodontic Sealer is a two-component paste-paste permanent root canal sealer based on epoxyamine resin. It is available in two delivery forms: AH Plus Endodontic Sealer in tubes, for an easy manual mix, or as AH Plus Jet Endodontic Sealer double-barrel syringe with a disposable mixing tip for intraoral use, offering a more precise, convenient, and faster procedure. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus Endodontic Sealer does not stain teeth.

· 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.

MIS Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.

The proposed MIS LYNX Conical Connection Dental Implants are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function. The proposed dental implants have an internal conical connection with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform. The proposed implants and cover screw are manufactured from titanium alloy (Ti-6A1-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The 3.3 mm diameter size implant is available in 10, 11.5, 13, and 16 mm lengths while the 3.75, 4.2, and 5.0 mm diameter size implants are available in 8, 10, 11.5, 13, and 16 mm lengths. The proposed implants feature an outer profile which has a coronal half which is cylindrical and an apical half which is conical. The threads are designed so the implant has a self-drilling property. The geometric design also includes spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants also feature a triangular neck ("V-Cut''). The gaps around the sides of the implant neck are designed to result in an open, compression free zone. The implant-abutment connection surface of the proposed MIS LYNX Conical Connection Implant is anodized for color coding to indicate the platform: yellow for narrow platform implants, purple for standard platform implants, and green for wide platform implants. The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in the patients. Cover screws are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. They are inserted into the implant and the gums are sutured over it. Their purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and removed, and replaced by either a healing cap or an abutment. The cover screws are also anodized for color coding.

The Endo Tabletop consists of a motorized endodontic handpiece for root canal cleaning and preparation. In addition, some models may also incorporate an electronic apex locator that assists the operator to locate the file tip in the root canal. The Endo Tabletop is intended solely for use by trained dental professionals on patients that need root canal treatment.

The Endo Tabletop is designed to drive dental endodontic instruments for a rotating treatment of root canals. Therefore, the Endo Tabletop provides different kinds of movement: 1. Continuous rotary motions (adjustable speed, torque and direction depending on the file used) 2. Reciprocating motions (speed, torque, direction, and angles depending on the file used) This functionality is provided by a Brushless Direct Current (BLDC) motor having speed and torque controls. The motor speed control is driven by a dedicated controller using pulse width modulation (PWM) of the excitation voltage and the motor torque control is performed by controlling and limiting the maximum current flow. The contra-angle transmits the motor movement in speed and direction to the endodontic file. The user can set the device by a graphical user interface on a 7" touch Thin-Film Transistor (TFT) display. The handpiece can be started/ stopped with a finger switch and foot control. All models can also be used for root canal length determination using the integrated apex locator functionality. This apex locator functionality is provided by evaluating the electical impedance between to the file clamp, placed into the dental root canal and the lip clip placed on the patient. The results of this estimation must be confirmed by standardized diagnostic imaging like an X-ray. The proposed apex locator function has two modes standalone mode. In standalone mode, the apex determination works with the lip and the endodontic file, which is connected to a file clamp. In combined mode, the apex determination works with the lip clip and the endodontic file which is connected to the contra-angle.

The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.

The Byte Aligner System consists of a sequential series of aligners fabricated of clear, thin, lightweight and flexible thermoformed polyethylene terephthalate glycol (PETG) [copolyester] plastics. The mechanism of action of the proposed Byte Aligner System is mechanical in nature; that is, tooth movement induced by orthodontic force application using continuous gentle forces. The aligners are made from elastic thermoplastic material that applies continuous gentle force to the teeth for treatment of tooth malocclusion. Treatment plans are modeled using CAD-CAM (computer-aided-design and computer-aided-manufacturing) software. Model archforms are created using rapid prototyping techniques like stereo-lithography. The aligners are thermoformed over the model archforms and are not themselves 3D printed. With the aligners seated on the patient's upper and/or lower dental arches, the teeth are progressively and gradually straightened over time by mechanical forces that are delivered via minor, incremental changes in tooth positions in each subsequent set of aligner trays that have been customized for the patient, delivered as a sequential series of trays to progressively reposition the teeth. The mechanics of how this happens is based on the forces caused by the elastic deformation of the aligner when worn by the patient. The forces are applied to the teeth, and also to the roots, causing pressure to the periodontium in the direction of the desired movement. Each aligner moves the patient's teeth in small increments from their original state.

CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: - CEREC Tessera Abutment Block - TiBase - CAD/CAM system. The CEREC Tessera ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The proposed CEREC Tessera Abutment Blocks are intended for fabrication of single cement-retained restorations. The CEREC Tessera Abutment System is comprised of the proposed CEREC Tessera Abutment Block, applicable TiBase, and CAD/CAM systems in both chairside (CEREC chairside software) and labside (inLab labside software) use. The CEREC Tessera ceramic structures are fabricated by milling the proposed CEREC Tessera Abutment Blocks. The CEREC Tessera Abutment Blocks are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure used to create 2-piece hybrid abutments and hybrid abutment crowns cemented to a TiBase used with dental implant systems. The patient-specific ceramic structure is then cemented to a TiBase to create the two-piece abutment which constitutes the final finished medical device.

The Surgical Trays are intended for organizing, sterilizing and storing of instruments. The Surgical Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch. Sterilization parameters: Pre-Vacuum Steam at 132 °C (270 °F) for 4 min with a 20 minutes dry time The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load: | Product name | Article<br>Number | Max Load (g) | Vent to Volume<br>Ratio (in-1) | |--------------------------|-------------------|--------------|--------------------------------| | OmniTaper Surgical Tray | 68015282 | 513.7 | 0.033 | | PrimeTaper Surgical Tray | 68015321 | 513.7 | 0.033 |

The proposed Surgical Tray is a reusable perforated container that is intended to store and organize the instruments needed before, during and after implant surgery as well as holding instruments during sterilization. The Surgical Tray is a container composed of three main components: a lid, a base and an overlay, all made of polyphenylsulfone (Radel R5000). The overlay has co-molded silicone tooling supports. The base has silicone rubber grommets to hold instruments. The base and overlay are custom printed to indicate the surgical workflow and the position of the instruments within the tray for the different product lines. The proposed Surgical Tray is available in one size with outer dimensions of 7.3 x 5.5 x 2.4 inches and offered in 2 inner tray configurations with varied instrument loads, see Table 5.1. | Table 5.1- Surgical Tray configurations | | | | | |-----------------------------------------|--------------|-----------------------|--------------|-----------------------------| | Product name | Model number | Max no of instruments | Max load (g) | Vent to volume ratio (in-1) | | OmniTaper Surgical Tray | 68015282 | 51 | 513.7 | 0.033 | | PrimeTaper Surgical Tray | 68015321 | 45 | 513.7 | 0.033 |

Atlantis® suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. Atlantis® suprastructures are intended for attachment to a minimum of two (2) implants. Atlantis® suprastructures are compatible with following implants and abutments: (list of compatible implants and abutments follows in the document)

Atlantis suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The subject Atlantis suprastructures include new compatible interfaces of the currently marketed Atlantis suprastructures made by milling (K163350) or additive manufacturing techniques (K163398) for the following abutments and implants: (list of compatible implants and abutments follows in the document). The design of the subject device is derived from patient dental models and completed by Dentsply Sirona technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of the Atlantis suprastructures are fabricated using additive manufacturing (AM) to produce a customized, patient-specific device. The Atlantis suprastructures subject of this bundled premarket notification are fabricated by milling or by additive manufacturing techniques. The milled Atlantis suprastructures are composed of commercially pure titanium (CPTi) or cobalt chrome alloy and are available in following design types: Bar, Bridge, Hybrid and 2 in 1. Additional design limitations regarding minimum required segment cross-section, maximum span between implants and maximum cantilever extension, have been introduced for Atlantis suprastructures made by milling. Atlantis suprastructures made by additive manufacturing are provided as Bridge and Hybrid types with optional mechanical retention (pin or cell retention) on the surface. The manufacturing of the Bridges and Hybrids of the Atlantis suprastructures by an additive manufacturing technique start from a titanium alloy and a cobalt-chrome alloy in powder form. Milled variants of the subject Atlantis® suprastructures are offered in versions composed of unalloyed titanium conforming to ASTM F67 (Standard Specification for Unalloyed Titanium for Surgical Implant Applications) and cobalt chromium alloy (CoCr) conforming to ISO 22674 (Dentistry – Metallic materials for fixed and removable restorations and appliances). Variants of the subject Atlantis® suprastructures which are fabricated utilizing additive manufacturing are manufactured using titanium alloy powder or cobalt chromium alloy powder conforming to ISO 22674 (Dentistrv – Metallic materials for fixed and removable restorations and appliances). Fixation screws for use with the subject Atlantis® suprastructures are composed of titanium alloy confirming to ASTM F136 (Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications). Screws are available for all compatible implants and abutments to screw the Atlantis suprastructures into the implant or onto the abutment. Labeling is modified by providing a separate compatibility chart which lists all implants and abutments compatible with the Atlantis suprastructures.

MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS short implants are to be used only with straight abutments.

The proposed MIS Dental Implant System entails a material modification and line extension of the MIS Lance+ Internal Hex Dental Implants and new offering of MIS Internal Hex Cobalt Chrome Abutments. Lance+ Dental Implants: A modification and line extension to the originally cleared Lance implants (K040807). Manufactured from titanium alloy, Ti- 6Al-4V ELI, compared to the prior CP titanium grade 4. Additional sizes are being added as a line extension. MIS Internal Hex Cobalt Chrome (CoCr) abutments: Pre-manufactured prosthetic components directly connected to the endosseous dental implant and intended for use as an aid in prosthetic rehabilitation. Intended for permanent restoration for single tooth or multiple units screw retained restorations. The lower part of the abutment is made of CoCr alloy, and the upper part is made of plastic (POM). The plastic part is dissolved during the casting process. The abutment is connected to the implant by a prosthetic screw.