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The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw.

This device is compatible with the following manufacturers' implant systems: Branemark, Southern Hexed, 3i, 3i Certain, Zimmer and Endopore.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also highly angled abutments (i.e. 15 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws are made from Titanium grade Ti-6A1-4V The abutment is placed over the implant and is mounted on to the implant with an abutment screw The abutments are compatible with the following implant systems:

Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide

This is a medical device 510(k) premarket notification for a dental abutment, not an AI/ML device. Therefore, the requested information (acceptance criteria for AI/ML performance, study details for AI/ML validation, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance) is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the "Vericore™ Abutment" to previously marketed dental abutments, based on its materials, intended use, and compatibility with various implant systems. It's a traditional medical device submission, not involving AI or machine learning.

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