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SPI® System Dental Implants are for one-stage or two-stage surgical procedures. SPI System Dental Implants are 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 SP1® ELEMENT implant Ø 3.5 mm and SP1® CONTACT 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 -

Thommen SPI Dental Implants are self tapping, root form, endosseous dental implants made of commercially pure grade titanium. The intended use of the subject endosseous dental implants includes a six week healing period when conventional loading protocols are used, rather than the currently recommended twelve-week minimum healing period, as well as to permit immediate functional loading of single-tooth or multiple unit restorations when good primary stability is achieved.

This 510(k) summary for the Thommen Medical AG SPI® System Dental Implants does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

The document primarily focuses on:

• Administrative Information: Manufacturer details, contact information, device name and classification.
• Intended Use: Description of how the dental implants are to be used (one-stage/two-stage procedures, immediate placement/function, single/multiple tooth applications, edentulous patients).
• Contraindications: Specific limitations for certain implant sizes and applications.
• Device Description: General description of the implants (self-tapping, root form, titanium, reduced healing period).
• Equivalence to Marketed Product: A statement that the device is substantially equivalent to predicate devices, which is the core of a 510(k) submission.
• FDA Correspondence: The official letter from the FDA confirming substantial equivalence.

Therefore, it is not possible to provide the requested table and study details based on the provided text. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and performance data like those for novel high-risk devices or software.

To answer your questions, one would need access to the full 510(k) submission or other regulatory documents that might detail any specific testing or performance data submitted to support the claims (e.g., for the reduced healing period). However, the summary provided here does not include such information.

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