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Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

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. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCI). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.

The BLC and TLC implants features the TorcFit connection and are available in the maximum endosteal outer diameters ø 3.3 mm, ø 3.75 mm, ø 5.5 mm and Ø 6.5 mm.

The BLC implants are available with the following length options:

• L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm.
• L 6 mm to L 18 mm for diameters Ø 3.75 mm and Ø 4.5 mm
• L 6 mm to L 16 mm for diameter Ø 5.5 mm
• L 6 mm to 14 mm for diameter Ø 6.5 mm.

The subject BLC implants are presented with RB (Reqular Base) and WB (Wide Base) prosthetic platform.

The TLC implants are available with the following length options:

• L 8 mm to L 18 mm for the maximum endosteal outer diameter Ø 3.3 mm,
• L 6 mm to L 18 mm for diameters ø 3.75 mm and ø 4.5 mm
• L 6 mm to L 12 mm for diameter Ø 5.5 mm
• L 6 mm to 10 mm for diameter Ø 6.5 mm.

The subject TLC implants are presented with the NT (Narrow TorcFit) RT (Regular TorcFit) WT (Wide TorcFit) prosthetic platform. The implant neck is available either as Standard (2.8 mm height) or Standard Plus (1.8 mm height) option.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. The document is an FDA 510(k) summary for Straumann® BLC and TLC Implants, which are endosseous dental implants, not an AI/ML device.

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