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Implantswiss Dental Implant System and Implantswiss Dental Abutment System
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant 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 is restricted to the anterior mandible based on four splinted-interforminal placed implants.
Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.
The Implantswiss Dental Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. This submission provides additional models to the existing family of implants and abutments.
The Implantswiss Dental Implants are provided as bone level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The additional devices added in this submission are all bone level implants, manufactured of pure titanium. The subject implant bodies have the same surface modification as the existing/cleared devices.
The Implantswiss Bone Level Implants have diameters of 3.3 mm, 4.3 mm 4.8 mm, and 5.5mm with lengths of 8 mm. 10 mm. 12 mm. Additional implant models are 3.3 mm diameter implants with straight design and 3.7 mm diameter implants with hybrid design (tapered apex).
The Implantswiss Dental Abutment System is used in combination with Implantswiss dental implants to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. The Implantswiss Dental Abutment System consists of provisional (temporary) and final type abutments, abutment screws, and the Healing Cap, a protective cover. The dental abutment provides the link between the dental implant and the prosthetic restoration that restores the chewing function.
The Implantswiss Dental Abutment System consists of Healing, Solid, Couple, Angled, Multi, O-ring, Multi-Unit. Premill, and Locator abutments with diameters 0 5.5 mm. 0 6.5 mm. 0 6.5 mm have lengths of 8.9 mm, 9.9 mm, 11.9 mm, 12.9 mm and 10.4 mm, 11.4 mm, 12.4 mm, 13.4 mm, 14.4 mm. Non-hex Couple abutments with diameters Ø 5.5 mm, Ø 6.5 mm have lengths of 8.7 mm, 9.7 mm, 10.7 mm, 11.7 mm and 12.7 mm.
Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm with lengths varying from 10.57 mm to 12.57 mm. Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 11.06 mm to 13.13 mm. Non-hex Bone Level Angled Abutments with 15° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.37 mm to 12.38 mm. Nonhex Bone Level Angled Abutments with 25° angles have diameters Ø 5.5 mm, Ø 6.5 mm with lengths varying from 10.86 mm to 12.93 mm. Tissue Level Angled Abutments have 15° angles with diameter Ø 3.5 mm with length 9.8 mm.
Bone Level Solid Abutments have diameters of Ø 5.5 mm and Ø 6.5 mm with lengths between 12.4 mm to 16.4 mm.
Bone Level O-ring Abutments have diameters of Ø 3.42 mm and Ø 3.7 mm with lengths between 10.1 mm to 13.1 mm. Tissue Level O-ring Abutments have a diameter of 3.5 mm with lengths 9.1 mm, 11.1mm and 13.1 mm.
Bone Level Multi Abutments have diameter of Ø 5.5 mm with length 15.63 mm. Non-Hex Bone Level Multi Abutments have a diameter of Ø 5.5 mm with length 15.63 mm.
Bone Level Healing Abutments have diameters of Ø 5.5 mm with lengths 9.5 to 13.5 mm. Tissue Level Healing Abutments have diameter of Ø 6.4 mm with lengths 7.4 mm, 8.4 mm and 9.9 mm.
Bone Level Locator Abutments have diameter of Ø3.86 mm with length 13.95 mm.
Bone Level Multi-Unit Abutments have a diameter Ø 4.8 mm with lengths 8.45 mm and 12.65 mm. Bone Level Multi-Unit Abutments with 17° angle have a diameter Ø 4.8 mm with length 7.2 mm. Bone Level Multi-Unit Abutments with 25° angle have a diameter Ø 4.8 mm with lengths 7.5 mm, 8.5 mm and 9.5 mm.
Bone Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 33.75 mm. Tissue Level Premill Abutments have pre-mill diameters of Ø 10 mm, Ø 14 mm and Ø 16 mm with length 30.08 mm. The finished premill custom abutment diameter is Ø 4.0 mm.
The provided document describes a 510(k) premarket notification for the Implantswiss Dental Implant System and Implantswiss Dental Abutment System. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify explicit "acceptance criteria" in terms of quantitative thresholds for device performance. Instead, it relies on demonstrating that the new models are "the same or similar" to previously cleared predicate and reference devices, and that relevant testing (biocompatibility, sterilization, shelf life, mechanical fatigue) leveraging existing data for the predicate device supports their continued safety and effectiveness.
However, based on the non-clinical testing section, the implicit acceptance criteria are that the device performance should be equivalent to the predicate devices and meet relevant ISO standards for dental implants and abutments.
| Acceptance Criterion (Implicit) | Reported Device Performance and Basis of Acceptance |
|---|---|
| Biocompatibility: Device materials are biocompatible and do not elicit adverse biological responses. | Biocompatibility testing was conducted on the predicate Implantswiss Dental Implant and Implantswiss Dental Abutment Systems per the ISO 10993 series of standards. This testing was leveraged for the subject devices due to identical materials and manufacturing as the predicate. |
| Sterilization: Sterilization process achieves a Sterility Assurance Level (SAL) of 10^-6. | Implants: Sterilized using a gamma ray sterilization process (ISO 11137-1 and ISO 11737-2) validated to ensure a SAL of 10^-6. LAL testing conducted per USP . Validation from the primary predicate leveraged due to identical materials, manufacturing, and worst-case analysis. |
| Abutments: Provided non-sterile. Recommended end-user steam gravity sterilization method and parameters validated to achieve an SAL of 10^-6 according to ISO 17665-1, ISO 17665-2, and ISO 11737-2. Validation from the primary predicate leveraged due to identical materials, manufacturing, and worst-case analysis. | |
| Shelf Life: Device maintains sterility and integrity over its intended shelf life. | Shelf life of the Implantswiss Dental Implant System remains at 2-years. Packaging testing of accelerated aged and real-time aged product previously demonstrated that the sterility of the Implantswiss Dental Implant System is maintained over the 2-year shelf life period. These tests (Visual Inspection ASTM F1886, Dye Penetration ASTM F1929-15, Seal Peel Strength Test BS EN 868-5:2009, Sterility test) were performed on the predicate devices and leveraged for the subject due to worst-case analysis. |
| Mechanical Integrity (Fatigue Resistance): Dental implant and abutment combinations can withstand dynamic fatigue forces consistent with the oral environment and relevant standards. This includes worst-case scenarios. | Fatigue testing, in accordance with ISO 14801 Dentistry- Implants-Dynamic fatigue test for Endosseous Dental Implants, was performed on the worst-case bone level Implant mated with the worst-case Implantswiss Dental Abutment. Results of the fatigue testing presented in the predicate submission found that the worst-case dental implant/abutment combinations were consistent with FDA Class II Special Controls guidance and ISO 14801. The additional models do not introduce a new worst-case and are covered by this prior testing. |
| Functional Equivalence: The additional models of implants and abutments are functionally equivalent to the predicate devices and compatible with their intended use (e.g., provide root form for prosthetic attachment, support prosthetic restorations). This includes similarity in design, size, dimensions, and material composition to existing cleared devices. | Implants: New implant models have the same intended use. Bench testing on worst-case dental implant found acceptable fatigue resistance properties. Minimum/maximum implant lengths match the predicate. Same surface treatment as predicate. Additional models are all bone level (original had both bone and tissue level). Manufactured from Commercially Pure Titanium Grade 4 (predicate used both pure titanium and titanium alloy). |
| Abutments: Similar in design, material, and basic features to predicate and reference devices. Enlarged diameter size ranges are covered by existing testing. Specific abutment types (Locator, Premill, Multi-Unit) compared to relevant predicate/reference devices, showing equivalence in design, dimensions, and manufacturing process (e.g., validated milling center for Premill). Bench testing on worst-case implant-abutment combinations for larger diameters found acceptable fatigue resistance. |
Study Proving Device Meets Acceptance Criteria:
The document describes a reliance on non-clinical bench testing and leveraging data from previously cleared predicate devices rather than a new standalone clinical study for the current submission.
2. Sample size used for the test set and data provenance:
- Test Set Sample Size: The document does not specify a distinct "test set sample size" in terms of cases or patients, as it's a bench study leveraging prior data for substantial equivalence. For the fatigue testing, it states that "fatigue testing... was performed on the worst-case bone level Implant mated with the worst case Implantswiss Dental Abutment." This implies a limited number of physical devices representing the "worst-case" scenario were tested as per ISO 14801. However, the exact number of samples tested for fatigue is not explicitly stated in this summary.
- Data Provenance: The data primarily comes from non-clinical bench testing (biocompatibility, sterilization, shelf life, mechanical fatigue) performed on the predicate device (K181266) and other reference devices (K160221, K150295, K161416, K181037). These studies were presumably conducted by the manufacturer, Novodent SA, or its affiliates and contracted labs. The country of origin of this specific testing data is not explicitly mentioned but is likely from the region where Novodent SA (Switzerland) and its partners operate. The studies are retrospective in the context of this 510(k) submission, as they were conducted for prior device clearances and are now being leveraged.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. This is a non-clinical device submission demonstrating substantial equivalence through bench testing, not a study involving human subjects or expert assessment for ground truth on disease detection.
4. Adjudication method for the test set:
Not applicable, for the same reasons as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an endosseous dental implant system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by established scientific and engineering principles, international performance standards (e.g., ISO 10993, ISO 11137-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, USP , ISO 14801, ASTM F1886, ASTM F1929-15, BS EN 868-5:2009), and material specifications (e.g., ASTM F-67, ASTM F-136). Compliance with these standards and material properties, validated by bench testing results, serves as the basis for "ground truth" for device performance.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not a machine learning model.
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