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510(k) Data Aggregation
(485 days)
SDS 1.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. SDS1.2_33xx implants are recommended as single-tooth implant for upper lateral and lower incisors for fixed prosthetic restorations only.
SDS 1.2 healing caps-disc, SDS .2 temporary caps and SDS 1.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS1.2 dental implant and enable the production/ fixation of long-term temporary restorations or protect the implant during healing phase for up to 180 days.
SDS1.2 dental implants are a one-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS1.2 dental implants are used to fix the prosthetic restoration and are suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS1.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS1.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs. The implants are provided sterile in sterile packaging and are intended for single use. SDS1.2 dental implants must not be re-sterilized or disinfected either. When delivered, all SDS1.2 dental implants are mounted with the disposable SDS1.2 insertion tool.
Temporary restorations can be produced either individually or by using the prefabricated SDS1.2 Temporary cap as basis. The SDS1.2 Temporary caps are made of PEEK (polyether ether ketone). The SDS1.2 Temporary cap may only be used for screw-retaining temporary restorations with SDS1.2 standard screw (SDS1.2_SS-T) and must not be cemented. The SDS1.2 Temporary caps are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.
SDS1.2 Healing caps-disc may be used to protect the dental implant. The Healing caps-disc are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. They can be fixed by screw-retaining with SDS1.2 standard titanium screws. The SDS1.2 Healing caps-disc are provided non-sterile and must be cleaned, disinfected and sterilized according to the instructions given in the "Instructions for use" document. They are intended for single-use and can stay for a maximum period of 180 days in situ.
The SDS1.2 dental implant system's acceptance criteria and the study proving it meets them are described below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SDS1.2 dental implant system are primarily based on demonstrating substantial equivalence to predicate devices through various tests and compliance with established standards. The reported device performance indicates that these criteria have been met.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 10993-5 (cytotoxicity). | Components subjected to biological evaluation per ISO 10993-1, including cytotoxicity tests per ISO 10993-5. Identical materials with comparable reference devices for type and duration of patient contact. Biocompatibility demonstrated by tests for cytotoxicity, bioburden, and endotoxins by an accredited laboratory. |
| Performance Testing | Stability, surface structure analysis, fatigue testing (ISO 14801), and laboratory tests for extractable cytotoxic substances, pyrogenicity, and total organic carbon. | Fatigue testing conducted in accordance with ISO 14801. Surface investigation performed with scanning electron microscope. Laboratory testing for extractable cytotoxic substances, pyrogenicity, and total organic carbon planned and performed as per FDA Guidance. Testing results analyzed and evaluated, demonstrating the SDS1.2 Dental implants meet existing requirements and acceptance criteria like the predicate devices. |
| Sterilization Validation | Compliance with ISO 11137-2 for device sterilization. | Minimal sterilization dose of 25 Gv proved, leading to a sterility assurance level (SAL) of ≤ 10^-6 as required by DIN EN 556-1. |
| Packaging Validation | Compliance with ISO 11607-1 and ISO 11607-2. | Packaging system performance validated per ISO 11607-1 and ISO 11607-2. Validation results demonstrated packaging system fulfilled requirements during sterilization and storage for up to 5 years (accelerated aging). For non-sterile products (healing and temporary caps), end-user sterilization validation performed according to ISO 17665-1, confirming cleaning, disinfection, and sterilization processes meet defined results. |
| Material Standards | Compliance with ISO 13356 for Y-TZP zirconia ceramics. | Implants are made of Y-TZP material in accordance with ISO 13356. Healing caps-disc also made of Y-TZP (ISO 13356). |
| General Compliance | Compliance with all applicable standards. | SDS 1.2 Dental implants meet all requirements of the applicable standards listed (e.g., ISO 7405, ISO 14971, ISO 15223-1, ISO 11137-1). |
| Substantial Equivalence | Demonstrating equivalence to predicate devices in intended use, technological characteristics, packaging, sterilization, and design. | The subject device is stated to be "substantially equivalent to the selected predicate devices" in terms of intended use, technological characteristics, packaging, sterilization, and design key elements. Minor differences are covered by reference devices and do not raise new questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance
The document indicates that non-clinical testing was performed, including biocompatibility, performance testing (e.g., fatigue testing), sterilization validation, and packaging validation. However, specific sample sizes for these tests are not explicitly stated. The document only mentions that "the testing results were analyzed and evaluated" and that testing was "planned and performed."
The document also explicitly states:
- "No animal testing"
- "No clinical testing"
Therefore, there is no information on sample sizes from human, animal, or clinical trials. The provenance of the data is implicitly from laboratory testing conducted as part of the regulatory submission process, likely by the manufacturer or accredited testing facilities. The specific country of origin for the non-clinical test data is not provided, though the manufacturer is based in Switzerland.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML device that requires human expert adjudication for ground truth establishment. The ground truth for performance evaluation is established through objective physical and chemical test methods and compliance with established industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device requiring human adjudication or ground truth establishment based on expert consensus for a test set.
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. The SDS1.2 dental implant system is a physical medical device, not an AI/ML diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The SDS1.2 dental implant system is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established through adherence to recognized international standards and validated laboratory test methods. This includes:
- Biocompatibility testing (ISO 10993 series)
- Mechanical performance testing (e.g., fatigue testing per ISO 14801)
- Material standards compliance (e.g., ISO 13356 for Y-TZP)
- Sterilization and packaging validation standards (ISO 11137, ISO 11607)
- Comparison to technological characteristics of predicate devices that have already demonstrated safety and effectiveness.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the context of AI/ML or statistical model development. The design and manufacturing processes are validated, and the device's performance is confirmed through non-clinical testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical medical device.
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