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ZENEX Implant System R-System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region.

ZENEX Implant System_R-System is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost.

The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).

There are 2 types of fixtures, and the dimensions are as following:

Tolerance of dimension shall be within ± 1% range.

The Abutments are below:

Fixture, Cover Screw, Healing Abutment is provided sterile, and valid for 5 years.
Other abutments are provided non-sterile and sterilized by end users.

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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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The DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading conditions are achieved.

• Ø3.3 mm implants are for replacing maxillary lateral incisors and mandibular incisors with delayed loading only.
• Ø5.0 mm and larger implants are intended for delayed loading in the molar region.

All digitally designed custom components (including Ti-Base and Pre-milled Blanks) for use with the DIMPLO Implant System are to be manufactured at a DIMPLO validated milling center.

The DIMPLO Implant System consists of fixtures, abutments, and attachments designed for dental implant procedures.

Fixture: Made of unalloyed titanium (Grade 4, ASTM F67), these dental implants are available in a range of diameters and lengths to accommodate various clinical applications in the maxilla and mandible. The surface is treated with SLA (Sandblasted, Large grit, and Acid-etched) and provided sterile via gamma irradiation. Available in two platform sizes: Mini and Regular.

Abutment: These components aid in prosthetic restorations. This category includes Cover Screws, Healing Abutments, Temporary Abutments, Cemented Abutments, Angled Abutments, Ti-Base, Pre-milled Blanks, Screws, Multi-unit Abutments, Healing Caps, and Cylinders.

Attachments: Includes Locatus Male Cap and Locatus Retention Male. The Locatus Male Cap is made of titanium alloy (Ti-6Al-4V ELI), while the Locatus Retention Male is made of nylon.

Fixtures and cover screws are supplied sterile. All other abutments and attachments are provided non-sterile and must be sterilized by the end user before use.

Ti-Base consists of a two-piece abutment that includes a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient-specific superstructure) at the top, composing the final abutment.

Superstructure and Bonding Materials

• Zirconia material: InCoris Zi (ZrO₂) (K123664, Sirona Dental Systems GmbH)
• Bonding agent: RelyX Unicem 2 Automix (K100756, 3M ESPE)

Design Envelope for Zirconia superstructure

Design Envelope for Pre-milled Blank

Note: Abutment Post Height is defined as the minimum cementable post height for single-unit restoration, measured as the height above the restorative margin.

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GM Helix Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The GM Helix Implant System with 3.75 and 4.0 diameter and 18 mm length are indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Implants in the pterygoid indication should be used in splinted applications that utilize at least two implants.

GM Helix LG Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. The GM Helix LG Implant System is indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

GM Mini Conical Abutment 45°:
The Mini Conical Abutments 45° and 60° are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

GM Mini Conical Abutment 45° Slim:
The Mini Conical Abutments 45° and 52° are indicated for surgical procedures in Zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

This premarket notification seeks to expand the indications for use of the subject implants and abutments, in order to include anchorage in the pterygoid region. These devices were previously cleared under 510(k) K163194, K190958, K190718 and K232099 for the functional and esthetic oral rehabilitation of the upper or lower jaw in edentulous or partially edentulous patients. The proposed implants and abutments remain with the same design and features already cleared in the original submission.

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Atlantis Abutment & Atlantis Abutment Milling
The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.

Atlantis Crown Abutment
The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.

Atlantis Conus Abutment
The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment-retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.

Atlantis Healing Abutment
The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.

Implant Manufacturer: Institut Straumann
Implant System: Straumann BLX
Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5
Abutment Platform Diameter (in mm): 2.69

Implant System: Neodent GM
Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0
Abutment Platform Diameter (in mm): 3.0

The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities.

Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities.

The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment, including the Conus and Healing abutments further described below, are available in Titanium or Gold-shaded (titanium nitride layer applied using PVD (Physical Vapor Deposition)) Titanium. The Crown Abutment which is another Atlantis® Abutment in Titanium, is only available in Titanium.

The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration.

The Atlantis® Crown Abutment in Titanium is also a custom fabricated abutment using the same internal CAD/CAM technology. The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient.

The Atlantis® Conus Abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis.

The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase.

The proposed Atlantis® Abutments in Titanium for Straumann BLX Implant are compatible with the Straumann BLX Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.5 5.0, 5.5 and 6.5 mm and in lengths of 8, 10, 12, 14, 16, and 18 mm all with identical mating geometry.

The proposed Atlantis® Abutments in Titanium for Neodent GM Implant are compatible with the Neodent GM Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, and 7.0 mm and in lengths of 7, 8, 9, 10, 11, 11.5, 13, 15, 16, 17 and 18 mm, all with identical mating geometry.

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Pro Zygoma dental implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. The Pro Zygoma dental implants may be used with single-stage or two-stage procedures and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to seek initial clearance for S.I.N. Tapered Pro Conical Zygoma Implant System which includes various endosseous dental implants and corresponding prosthetic components. S.I.N. Tapered Pro Conical Zygoma Implant System adds to the S.I.N. Dental Implant System, which includes several components previously cleared in K231127 and K240609, as well as other features of the Tapered Pro Conical Implant System previously cleared in K240187. This submission includes Pro Zygoma dental implants for placement in the maxillary arch, with corresponding Pro Conical Multi-unit Abutments with up to 60° angulation.

The subject Pro Zygoma dental implants have an internal conical abutment connection, with a 15° cone taper. The Pro Zygoma dental implants are provided with body/platform diameters of 3.8 and 4.2 mm, and each body/platform size is provided in overall lengths of 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55, 57.5 and 60 mm. For all implants, the threads start at the apex and extend 16.8mm coronally.

The external machined surface of the subject Pro Zygoma implants, as well as the external surface of the Pro Conical Angled multi-unit abutments are colored yellow for aesthetic and identification purposes by a standard anodization process in which the devices are submerged in an electrolytic solution and exposed to an electric current to increase the thickness of the natural oxide layer on the surface and impart a distinctive color. No dyes are used in this process. The multi-unit abutment screw (part number SCMUAS) is anodized blue by the same process. The anodization process for the subject Pro Zygoma implants is identical to that used on the reference implant devices cleared in K240187. The anodization process for the subject Pro Conical Angled multi-unit abutments and multi-unit abutment screw is identical to that used on the primary predicate abutment devices cleared in K231127.

Resorbable Blast Texturing (RBT) is applied to the threaded surface of all subject device implants creating a random, roughened texture which increases the implant surface area and helps achieve hard tissue (bone) attachment with the implant. RBT is the application, under pressure, of biocompatible hydroxylapatite (HA) particles (conforming to ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants) to the exterior of the machined implant threads. Not to be confused with HA coating, RBT processing uses HA particles to blast the implant surface without depositing HA onto the surface. The HA used for RBT processing does not remain on the surface post-processing. HA media grain size is between 180 – 300 µm for the surface trademarked as RBT (surface finish at 60 Ra minimum).

The subject Pro Conical Angled abutments are multi-unit, indexed abutments for use only with the subject Pro Zygoma implants. The 45°, 52° and 60° Pro Conical Angled Multi-unit Abutments have a prosthetic platform diameter of 4.8 mm, and a gingival height ranging from 1.5 mm to 3.0 mm and are designed only for use with the Pro Zygoma implants. The internal conical implant-abutment connection of the subject devices is identical to that of the BioHorizons reference devices included in K240187, thus the subject Pro Zygoma dental implants are fully compatible with the BioHorizons Conical Multi-unit Angled Abutments (17° and 30°).

All subject dental implants are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All subject implants have a resorbable blast textured (RBT) surface treatment, identical to that cleared in K240187. All subject multi-unit abutments are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. All subject implants and abutments are provided sterile to the end user.

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GEN5 and GEN5+ implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially or fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

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

Short (<9mmL) Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

GEN5 and GEN5+ Abutment System: The GEN5 and GEN5+ Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques.

The GEN5™ and GEN5+ Dental Implant System consists of a root form Endosseous dental implant, Endosseous dental implant abutment, and various other prosthetic/restorative components (medical devices) to plan, implant, and support restorations for edentulous patients.

GEN5 and GEN5+ Dental Implants are supplied as a two-piece implant assembly for use in a two-stage or 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 or as a free-standing single tooth replacement. The standard GEN5 Implants are for use in a two-stage surgical procedure. The first surgery is for implant placement, and the second surgery is a few weeks prior to start of prosthetic rehabilitation. By the addition of an abutment of any type at time of implant placement, the implant functions as a one-stage, two-piece system.

The GEN5 Implant and GEN5+ Implant are the exact same dental implant (internal hex implant). The difference between the two is that the GEN5+ Implant includes a pre-attached hex engaging Extender Healing Abutment (accessory restorative component) screw-retained on the GEN5 Implant prior to packaging requiring only a single surgical procedure prior to prosthetic rehabilitation.

The top (coronal portion) of the GEN5 Implant body is with a 2.0mm straight neck. The depth gauge lines at 1mm, 2mm and 2.5mm (or at 1mm and 2mm on the ≤9mm length) from the top of the implant facilitate the placement level with the crest of the ridge or 1mm above the crest of the ridge for all implants except the 3.7mmD x 7mmL. The lower apical aspect of the Implant is tapered with double-lead progressively deeper buttress threads. Three cutting flutes extend over the tapered portion of the implant's body. The GEN5+ Implants offer the additional flexibility of a 2mm extender collar that can serve as the trans-mucosal collar of an abutment or can be removed for abutment connection directly to the top of the implant for vertical flexibility.

The GEN5 and GEN5+ dental implant body is available in five diameter sizes (3.7mm, 4.2mm, 4.7mm, 5.2mm, and 5.7mm) with two platform diameters (3.5mm or 4.5mm), and five lengths (7mm, 9mm, 11mm, 12.5mm, and 14mm). GEN5 and GEN5+ Implants have 2.0mmL of their coronal surface anodized with either a gold (3.5mmD) or a rose gold (4.5mmD) color for aesthetic purposes to help identify the two platform diameters while the remainder of the Implant has gone through a surface treatment (blasting) to create a microtextured surface roughness. These Implants (and the devices included in the packaging) are sold sterile. The GEN5 and GEN5+ 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 GEN5 and GEN5+ have an internal hex for abutment connection, which is designed to receive multiple abutment variations expanding its restorative options and allowing for the implant to be used for support of attachment-retained overdentures and cement-retained or screw-retained prostheses.

The GEN5 Implants are provided with an Internal Hex Carrier while the GEN5+ Implants (a GEN5 Implant pre-fitted with an Extender Healing Abutment) are packaged with an Extender Carrier and an Extender Carrier Fixation Screw.

The devices are sold in gamma irradiated sterile packaging which consists of an outer vial and an inner vial which is sealed with a threaded cap.

The Extender Carriers and Extender Carrier Fixation 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).

The various devices included in the GEN5 and GEN5+ Dental Implant System (such as Endosseous dental implant abutments 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 prosthetic and restorative components (Straight Contoured, Angled-Contoured, ASC, Multi-Unit Abutments, Titanium Multi-Unit Abutment Copings, Titanium Temporary, Healing, Extenders, Cover Screws, Transfers, and Analogs) are all manufactured from titanium alloy (Ti-6Al-4V ELI) and anodized.

The prosthetic components (PEEK Temporary Abutments) are all manufactured from polyetheretherketone (PEEK).

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The HexaPLUS S OneDrill Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement-retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. The system is intended for delayed loading.

The HexaPLUS S OneDrill Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the indications for use, the technology used, the material compositions and performance characteristics. The surface of the implants are treated by SLA method. Implants with 4.50mm and 5.25mm body diameter are provided in lengths of 8.5, 10, 11.5, 13.0, 14.5, and 16 mm. Implants with 6.5mm and 7.5mm body diameter are provided in lengths of 8.5, 10, 11.5, 13.0, and 14.5.

The system includes the following components.

Fixtures

• Size: 4.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5/16.0mm (L)
• 5.25mm (Dia.) x 8.5/10.0/11.5/13.0/14.5/16.0mm (L)
• 6.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5
• 7.50mm (Dia.) x 8.5/10.0/11.5/13.0/14.5

Abutments

• Healing Abutment
• One-Step Abutment
• Final Cement Abutment
• Straight Abutment
• Angled Abutment
• Temporary Abutment
• Ball Abutment

Cover Screw

• Size: 3.45mm (Dia.) x 4.9

Abutment Screw

• Size: 2.30mm (Dia.) x 8.25

Multi Angle Abutment Screw

• Size: 2.30mm (Dia.) x 8.20

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The Paltop Dental Implant System Internal Hex Standard and Wide Platforms implants (implant diameters 3.75 and above and lengths 8mm and above) as well as Conical Connection implants (implant diameters 3.75 and above and lengths 8mm and above), are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.

The Paltop Narrow Implant (Internal Hex and Conical Connections, for implant diameters 3.25 and lengths 10mm and above) is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the interdental spaces are limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components and update previously cleared to the Paltop Advanced Dental Solutions, Ltd product line of endosseous dental implants, abutments, and prosthetic components. Specifically, this submission seeks marketing clearance for dental implants with body diameters of 3.25 mm, 3.75 mm, 4.2 mm, 5 mm, and 6 mm various compatible abutments, two (2) cover screws, and one (1) additional abutment screw.

The subject device dental implants are self-tapping, threaded, root-form dental implants intended for the functional and aesthetic rehabilitation of the partial or fully edentulous mandible or maxilla. Once osseointegrated, the implants act as an anchor for various fixed or removable prosthetic solutions. All subject device implants are intended to be placed at the bone level (crestal position). All implants with diameters of 4.2 mm and 5.0 mm diameters allow for the option of platform switching.

Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal hex connection. Each implant line is provided with a body diameter of 3.25 mm, and interface with the Paltop Narrow Platform (NP) prosthetic components, with an interface diameter of 2.90 mm. Implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm. Each implant line also is provided with body diameters of 3.75, 4.2, and 5 mm; these implants are provided in lengths of 8, 10, 11.5, 13, and 16 mm and interface with the Paltop Standard Platform (SP) prosthetic components, with an interface diameter of 3.65 mm.

The Advanced +, Dynamic, PAI, and PAI TC dental implant lines also are provided in a body diameter of 6 mm, in lengths of 8, 10, 11.5, 13, and 16 mm. Implants with the 6 mm body diameter interface with the Paltop Wide Platform (WP) prosthetic components, with an interface diameter of 4.4 mm. The Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal threaded section (UNF 1-72) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.

The subject device conical connection implants (Dynamic Conical MC, and PCA) are provided in body diameters of 3.25, 3.75, 4.2, and 5 mm. Conical implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm; all other body diameter sizes are provided in lengths of 8, 10, 11.5, 13, and 16 mm. All conical implants have a recessed internal section for abutment indexing, and an internal threaded section for connecting with corresponding compatible healing caps, abutments, and screws. Subject device implants with a conical geometry connect to conical connection prosthetic components. The conical connection prosthetic interface diameter is 2.9 mm.

The subject device conical connection implants (Dynamic Conical MC, and PCA) have a recessed 22° internal conical taper and a section for abutment indexing, as well as a threaded section (M1.6 x 0.35) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.

All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.

The subject device endosseous dental abutments provide a range of cement-retained and screw-retained prosthetic solutions for dental implant restoration. Subject device abutments include seven (7) compatible implant abutment designs: Healing Caps, Straight Abutments, Angulated Abutments, Multi-Unit Abutment, Temporary Abutments, Snap-On Abutment System (SAS), and Ball Abutments for subject and non-subject device implants of the same families (Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants) and the conical healing caps are compatible with conical subject and non-subject devices (PCA, Dynamic Conical, Dynamic Conical MC). Abutments are offered in either indexed (engaging) or non-indexed (non- engaging) external connections that are compatible with the subject device implants.

Subject device abutments are compatible with the subject device implants with the internal hex connection, and the conical connection implants (subject device healing cap), as well as previously cleared compatible implants as described in Table 4 Subject Device Component Compatibilities. Subject device abutments are compatible with subject device implants according to their appropriate internal connection and platform. Subject device implants with an internal hex connection and diameter size of 3.25 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Narrow Platform (NP) Abutments, as well as abutments cleared in K210117. Subject device implants with an internal hex connection and diameter size of 3.75 mm, 4.2 mm and 5.0 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Standard Platform (SP) Abutments, as well as abutments cleared in K232740. The 6.0 mm diameter internal hex implants of all lengths (Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Wide Platform (WP) Abutments, as well as abutments cleared in K232740. Subject device implants with a conical connection (Dynamic Conical MC and PCA) are compatible with the subject device conical connection healing cap, as well as conical connection abutments cleared in K220200. The 5.0 mm diameter conical connection implants of all lengths (Dynamic Conical MC and PCA) are compatible with conical connection abutments cleared in K232740.

All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.

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