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SPI® Dental Implant, INICELL® is for one-stage or two-stage surgical procedures. SPI Dental Implant, INICELL is intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used in immediately loaded cases.

Contraindications for the use of SPI ELEMENT INICELL implant Ø 3.5 mm and SPI CONTACT INICELL implant Ø 3.5 mm:

These implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending movements.

• Restoration of posterior teeth in the upper and lower jaw
• Single-tooth restoration of canines and central incisors in the upper jaw
• Any application involving retentive anchors

The design of the Thommen Medical AG endosseous dental implants has been modified to include a new surface treatment that will be marketed as the SP1® Dental Implant, INICELL® All features other than this surface treatment of the implants remain the same as the TST Surface implants. Other components of the SP1® Dental Implant System have not been modified, are suitable for use with the modified implants, and will be sold under the SPI Dental Implant System name.

The provided 510(k) summary for the Thommen Medical AG SPI® Dental Implant, INICELL® does not contain information related to acceptance criteria, device performance, or any studies proving the device meets specific acceptance criteria.

Instead, the document focuses on establishing substantial equivalence to previously marketed predicate devices based on similarities in intended use, operating principle, basic design, materials, packaging, and sterilization processes.

Therefore, I cannot provide the requested information in the format specified. The document primarily functions as a regulatory submission demonstrating equivalence, not as a report on a clinical or performance study with defined acceptance criteria and statistical outcomes.

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