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Medentika Custom Abutments AS (Angulated Screw Channel) are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Custom Abutments AS are intended for use with the Straumann® CARES® System. All digitally designed Medentika Custom Abutments AS are intended to be manufactured at a Straumann® validated milling center. The final patient matched form is a Custom Abutment AS.

Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, and Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The Custom Abutments (previously named MedentiCAD and PreFace abutments) can be used in combination with cemented prosthetics, e.g., crowns and superstructures, to reconstruct the function and esthetics of lost teeth. The Custom Abutment is a one-piece abutment, which is a customized abutment that is digitally designed by the customer with Straumann® CARES® Visual and can be only milled and ordered from the Straumann validated milling center. The abutments have an implant-specific connection interface for the respective compatible implant. The previously cleared Custom Abutments feature a straight screw channel for the abutment screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments AS (Angulated Screw Channel) to the Medentika Custom Abutment Portfolio. The subject Medentika Custom Abutments AS can be designed and manufactured with an angled screw channel (as opposed to the predicate straight screw-channel), so that the screw-exit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angulated to allow screwdriver access at an angle up to 25°.

Each of the abutment to implant connection geometries (in terms of Series and implant diameter) currently exists for the existing marketed Medentika Custom Abutments (with straight screw channel). No new compatible implant is added, in terms of series, implant diameter, and implant platform diameter within this submission.

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The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

The Straumann Custom Abutments (previously named Straumann CARES Abutments) are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. The Custom Abutments are patient-matched abutments; the customer scans the intraoral situation and designs the shape using a Straumann-approved CAD/CAM software (such as Straumann CARES Visual). The design data is then transferred to Straumann where the fabrication of the custom abutment is carried out at a Straumann validated milling center (FEI: 3024185724 or FEI: 3011221537). The existing Custom Abutments feature a straight screw channel for the basal screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments with an angled screw channel to the Straumann Custom Abutment Portfolio. The subject Custom Abutments can be designed and manufactured with an angled screw channel (as opposed to straight), so that the screwexit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angled, the screwdriver maximum angle is 20°.

The Custom Abutments are designed for connection to implants of the Straumann Dental Implant System. The Custom Abutments have an implant-specific connection interface for the respective compatible implant. The Custom Abutments with the SynOcta geometry (RN or WN) are designed for connection to the Straumann Tissue Level (TL) implants. Those with the CrossFit geometry (NC or RC) are designed for connection to the Bone Level (BL) and Bone Level Tapered (BLT) implants. The Custom Abutments with the TorcFit geometry, are designed for connection to the Straumann Bone Level BLX and BLC (RB/WB or WB) or Tissue Level TLX and TLC (NT, RT, WT) implants. The basal screws feature threads to secure the abutment with the implant inner geometry. The basal screws also contain the connection geometry to mate with the AS screwdrivers for installation into the implant.

The provided text is a 510(k) Summary for "Custom Abutments" and details the substantial equivalence of the device to legally marketed predicate devices. It does not contain information on an AI/ML-driven device or study results proving a device meets acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, FROC, etc.).

The document describes a dental implant abutment designed for customized patient use, with a key modification being the addition of an angled screw channel. The non-clinical testing sections focus on mechanical fatigue testing, digital workflow validation, sterilization, MRI compatibility, and biocompatibility, as is typical for a medical device of this type.

Therefore, I cannot fulfill your request for information on acceptance criteria and study proving device meets acceptance criteria for an AI/ML device, as the provided text pertains to a traditional medical device (dental abutments) and does not mention any AI/ML component.

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