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The Adin Long Dental Implant System is intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices such as artificial teeth in order to restore the patient's chewing function in fully or partially edentulous patients. The implants are intended for multi-unit, full-arch, screw-retained prosthetic restorations and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Adin Touareg-OS Zygomatic Dental Implants are intended for placement in the zygomatic bone in patients with severe atrophic maxilla; they may be used with implant-level framework designs with 45° to 60° angulation.

Adin Long Dental Implant System is an extension of previously cleared dental implant devices, designed to expand the product offering and provide additional options for dental restoration procedures. Specifically, this submission seeks marketing clearance for the following implants and abutments:

(1) Adin TouaregTM-OS Zygomatic Dental Implants:

• Outer diameter of 4.2 mm
• Available Lengths: 35.0mm, 37.5mm, 40.0mm, 42.5mm, 47.5mm, 50.0mm, 52.5mm and 55.0mm.

(2) Adin Long Dental Implant System -RS TMATM:

• Connection: RS
• Diameter: 4.9 mm
• Available Configurations (Angle / Gingival Height):
  • 45° / 4 mm
  • 52° / 5 mm
  • 60° / 5 mm

ADIN TOUAREGTM-OS ZYGOMATIC DENTAL IMPLANTS:

Adin TouaregTM-OS Zygomatic dental implants is a threaded, root-form dental implants made of biocompatible Ti-6Al-4V ELI alloy complying with ASTM F136-13(2021)e1 – "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications" and ISO 5832-3:2021 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

Adin TouaregTM-OS Zygomatic Dental Implants are used for surgical placement through the maxillary arch and anchored in the zygomatic bone to provide support for prosthetic devices such as artificial teeth to restore the patient's chewing function in edentulous or partially edentulous patients only with severe atrophic maxilla.

Adin TouaregTM-OS Zygomatic Dental Implants are intended for extra-maxillary extra-sinus procedures, and their use is limited to ZAGA-4 extra-maxillary implant placement.

The device is intended to be used under the following clinical conditions and surgical parameters:

• Multi-unit reconstruction (TMA), with a rigid splinting of minimum two implants.
• For an edentulous/full mouth restoration, should be used together with at least two standard implants.
• It should be used only in patients with severe atrophic maxilla.
• Extra-maxillary extra-sinus procedures intended to be anchored in the zygoma bone
• One stage or two stage surgical operation.
• Immediate loading (function) is applicable provided that stability requirements are satisfied.

All TouaregTM-OS Zygomatic implants have OsseoFixTM surface treatment which was previously cleared under Adin's 510(k) K212775 for Adin's legally marketed Adin Short Implants and remained unchanged since these clearances.

ADIN TOUAREGTM-OS ZYGOMATIC IMPLANTS – RS TMATM

The TMATM system is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.

Adin TouaregTM-OS Zygomatic implants are intended for TMA in combination with a rigid splinting of a minimum of 2 conventional dental implants.

Screw-retained abutments are made of titanium alloy 6Al-4V ELI complying with ASTM F136-13 and ISO 5832-3:2021 - Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.

The TMA system is used to elevate seating platform of restoration when restoration at implant level is not indicated or practical due to the depth or emergence angle of the implant.

The Adin TouaregTM-OS Zygomatic Implants - RS Angled TMATM (45°, 52°, 60°) are only intended for use with the proposed Adin TouaregTM-OS Zygomatic Dental Implants.

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ZENEX Implant System_Short(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.

Short and Wide implants must be splinted to adjacent implants in areas of poor bone quality or high occlusal forces.

ZENEX Implant System_Short (R-System) is a thread type implant made of pure titanium according to ASTM F67 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). The entire length of 6.25mm of implant bodies are implanted into the bone to connect prosthetic devices of a dental implant set with the human body (mandibular or maxillary bone).

There is a type of fixture, and the dimensions are as follows:

Tolerance of dimension shall be within ± 1% range.

The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd.

Fixture is provided sterile, and valid for 5 years.

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Straumann® dental implants for use in the pterygoid region are indicated in cases of severe jaw resorption for the functional and esthetic oral rehabilitation of the upper jaw in edentulous or partially edentulous patients. This indication is limited to Straumann® BLC bone-level implants with a length of 18 mm and a diameter of 3.75 mm (RB platform). Implants anchored in the pterygoid region shall be placed using a free-hand surgical technique and restored only in splinted applications utilizing at least two implants in combination with screw retained abutments.

The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. Within the scope of this submission, the Straumann® BLC bone-level implants (diameter 3.75 mm, length 18 mm) are intended for surgical placement in the pterygoid region of the maxilla to provide posterior support for multi-unit, splinted prosthetic restorations. The implants are to be used only in combination with compatible screw-retained angled abutments (17° or 30°) and are not intended for single-unit or single-tooth restorations.

This premarket notification seeks to expand the previously cleared indications for use of the Straumann® BLC implants (K230108) to include anchorage in the pterygoid region, without changes to the fundamental device design, materials, surface characteristics, or implant-abutment connection.

The subject BLC implants indicated for the pterygoid application are provided in a single prosthetic platform identified as RB (Regular Base) for Ø 3.75 mm diameter implant (18 mm length only).

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Dentis SQ -SL AXEL Fixture 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 terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis SQ-SL AXEL Fixture is two types as Mini and Regular according to the connection. Dentis SQ-SL AXEL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.

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

The dimensions of fixtures are as following:

Tolerance of dimension shall be within ± 1% range.

Dentis SQ-SL Fixture is compatible with K192688 and K210134 as below:

Dentis SQ-SL Fixture Mini is compatible with K210080 as below:

Dentis SQ-SL AXEL Fixture is provided sterilized.

Dentis SQ-SL AXEL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

Materials:

• SQ-SL AXEL Fixture and SQ-SL AXEL Fixture Mini are fabricated from Pure titanium of ASTM F67

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NobelActive® S TiUltra™, NobelActive® S TiUnite®

NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications.

This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelReplace® S TiUltra™, NobelReplace® S TiUnite®

NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function.

The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants are indicated for single or multiple unit restorations.

The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants can be used in splinted or non-splinted applications.

The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelParallel™ S TiUltra™, NobelParallel™ S TiUnite®

NobelParallel™ S TiUltra™ and NobelParallel™ S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel™ S TiUltra™ and NobelParallel™ S TiUnite® implants are indicated for single or multiple restorations in splinted or non-splinted applications.

This can be achieved by 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with <7 mm length are for delayed loading only when appropriate stability has been achieved.

The Subject Device, Nobel Biocare S Series Implants, comprises of six Device Lines NobelActive S TiUltra™, NobelParallel™ S TiUltra™, NobelReplace S TiUltra™, NobelActive S TiUnite, NobelParallel™ S TiUnite, NobelReplace S TiUnite.

Nobel Biocare S Series Implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental prostheses to restore chewing function. The Subject Device features a consistent diameter at the implant-abutment interface, regardless of the implant size or type. This means that the prosthetic components, such as abutments and restorative elements, have uniform dimensions and connections across all implant sizes within the system. The connection used is the Narrow Platform (NP) conical connection.

The implant bodies of the Subject Devices and Predicate devices are the same. This allows use of the same drills and drilling protocols, rescue procedures and rescue tools. By using the existing Narrow Platform connection, the same prosthetic workflows, prosthetic components, and lab components can be used.

The implants are available in different sizes as listed in Table 1.

The Nobel Biocare S Series Implants are manufactured from commercially pure titanium and incorporate a conical connection (Size Narrow Platform (NP)) with a hex interface in the collar region, which combines with Nobel Biocare's existing prosthetic Abutment portfolio cleared in K071370, K083100, K132746, K233208, K202344, K200040, K132749, K161416, K202452, K240346, K041236, K133731, K061003 and K161435.

Table 2 outlines which single-unit restoration abutments with an NP connection can be used with the subject device.

Table 3 outlines which multi-unit restoration abutments and bridges with an NP connection can be used with the subject devices.

Table 4 outlines the temporary and healing restorations with an NP connection that can be used with the subject devices.

Table 5 lists the corresponding submissions where compatible Class II accessories with an NP connection were previously identified.

The On1™ Base/On1™ Base Xeal must not be used in combination with NobelActive® S, NobelParallel™ S, NobelReplace® S implants.

NobelActive® S, NobelParallel™ S, NobelReplace® S implants in combination with NobelProcera® Angulated Screw Channel Abutment and NobelProcera® FCZ Implant Crown are indicated for maxillary lateral and mandibular central/lateral incisors only.

NobelActive® S, NobelParallel™ S, NobelReplace® S implants may be used in combination with NobelProcera® Angulated Screw Channel Abutment and NobelProcera® FCZ Implant Crown up to a maximum angulation of 20°

NobelActive® S, NobelParallel™ S, NobelReplace® S implants may be used in combination with GoldAdapt Engaging CC NP abutments in straight (0°) configurations only.

No angulation is allowed for Universal Base Conical Connection Abutments when mated with the NobelActive® S, NobelParallel™ S, NobelReplace® S implants with diameters greater than 3.5mm.

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BIORES Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Implants with a diameter of 3.7 mm are only suitable for anterior tooth restoration.

BIORES Dental Implant System includes Implant, Abutment and Accessories. Abutment and Accessories are only compatible with our company's Implant to restore patients' chewing function.

Implant is made of Titanium Grade 4 material that complies with ASTM F67 and has a sandblasted and acid-etched surface. The implant is supplied sterile and is gamma sterilized. The sterilization is shelf life for 8 years. Implant is classified into Type I Implant and Type II Implant according to different thread designs. Type I Implant feature conical threaded structures, consisting of a top, neck, and body. The top of the implant is machined (0.4mm length), the neck has trapezoidal micro-threads, and the body has large threads in a reverse sawtooth pattern, with rotational cuts at the large thread locations. Type II Implant have a conical threaded design, consisting of a top, and body. The implant body has large threads, and the large thread area has rotational cuts.

Abutment and Accessories include bonding abutment(straight only), healing abutment, central screw, and cover screw, all made from Ti-6Al-4V ELI titanium alloy material compliant with ASTM F136, without any surface treatment. The bonding abutment is provided non-sterile and must be sterilized by the user using steam sterilization prior to use; the healing abutment, central screw, and cover screw are provided sterile, with a sterilization shelf life of 5 years.

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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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