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IPDmilled Blanks are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed CAD/CAM customizations for the IPDmilled Blanks are to be designed and manufactured according to digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, milling machine and associated tooling and accessories. Compatible Implant Systems: Dentium Co., Ltd Implantium, Friadent Implant Systems, Neoss ProActive Implant, SPI® Dental Implant, Inicell®, BEGO Semados® S-Line, ANKYLOS® C/X Implant System, MIS V3 Conical Connection Dental Implant System, Conical Connection Implants (MIS® C1), MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments, PRAMA White Implant Systems, Altatec GmbH CAMLOG®/CONELOG® PROGRESSIVE-LINE Implants, Straumann TLX Implant System, Kontact Dental Implant System, ICX-Implant System, Tapered Pro Conical Implant System, Straumann® Tissue Level, Zimmer Tapered Screw-Vent®, Nobel Biocare® Nobel Active®, Straumann® Bone Level Tapered Implants, Neodent Implant System – GM Line, Osstem Implant System, Xpeed AnyRidge Internal Implant System, 3i Osseotite® Certain® Dental Implants, Astra Tech Implant System (Osseospeed®), OsseoSpeed™ Plus, BioHorizons Tapered Internal Implant System, MIS Internal Hex Dental Implant System (MIS® Seven®), Straumann BLX Ø3.5 mm Implants, Straumann® BLX Implant System, ALTATEC Camlog Screwline Implant System, Replace TiUnite Endosseous Implant.

The purpose of this submission is to expand abutment categories of IPD Dental Implant Abutments, which were previously cleared.

IPDmilled Blanks is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPDmilled Blanks have a pre-manufactured connection interface that fits directly with a pre-specified dental implant. The customized shape of the abutment is intended to be designed and manufactured according to a digital dentistry workflow or to be sent to an IPD validated milling center for manufacture. IPDmilled Blank is delivered non-sterile and the final restoration, including the screw, is intended to be sterilized at the dental clinic before it is placed in the patient.

The IPDmilled Blanks are blistered together with their specific screw. The screws are intended to attach the prosthesis to the dental implant.

The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".

The design and manufacturing of the custom abutment will be conducted using a digital dentistry workflow requiring the use of the following equipment and software:
Intraoral Scanner: 3Shape TRIOS A/S Series
Desktop Scanner: 3Shape E Series.
Design Software: 3Shape Abutment Designer Software, K151455.
AbutmentCAD, K193352.
Milling unit: CORiTEC 350i PRO / CORiTEC 350i Loader PRO with MillBox CAM software.

IPDmilled Blank libraries' have built-in design limitations, and the user isn't allowed to exceed these limitations. The custom abutment design limitation specifications are as follows:
Minimum gingival height: 0.5 mm
Maximum gingival height: 6.0 mm
Minimum wall thickness: 0.4 mm
Minimum post height: 4.0 mm

All IPDmilled Blanks are for straight abutments only.

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Nobel Biocare's Procera Zirconia Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Zirconia Abutments fit the following endosseous implants: Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm

Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.

Nobel Biocare's Procera Zirconia Abutment for Camlog Implant System is similar in design, intended use, and operation to the abutments cleared in predicate devices.

The provided text describes a 510(k) summary for the Procera Zirconia Abutment for Camlog Implant System. It focuses on device description, intended use, and substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for assessing device performance.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, and performance metrics as this information is not present in the provided document.

This particular document is a regulatory submission summary, indicating the device has been deemed substantially equivalent to existing devices, which means it meets the regulatory requirements for marketing, but it does not detail the specific performance testing data that might be associated with such a determination.

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Nobel Biocare's Procera Titanium Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Procera Titanium Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm

• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm

Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is fabricated to the exact shape, size, and specifications determined in the design process in order to achieve a personalized device that fits precisely, and properly functions, according to each patient's individual needs.

Nobel Biocare's Procera Titanium Abutment for AstraTech and Camlog Implant Systems is similar in design, intended use, and operation to the abutments cleared in predicate devices.

The provided text (K061478) is a 510(k) summary for a medical device called "Procera Titanium Abutment for AstraTech and Camlog Implant Systems." This document describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics but no new questions of safety and effectiveness are raised. It does not generally involve a new clinical study with acceptance criteria in the same way an AI/ML device would.

Therefore, I cannot provide the requested information based on the provided text. The tables and study details you've asked for (such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are typically associated with performance evaluations of AI/ML-driven devices, which this dental implant abutment is not.

The document essentially states that the device is similar in design, intended use, and operation to previously cleared abutments and is therefore substantially equivalent.

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Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit Abutments fit the following endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm
• Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• Ankylos 3.5, 4.5, 5.5, 7.0 mm

Nobel Biocare's Multi-Unit Abutment is an artificial tooth abutment designed to fit and function on the below endosseous implants:

• AstraTech 3.5, 4.0, 4.5, 5.0 mm -
• -Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
• . Ankylos 3.5, 4.5, 5.5, 7.0 mm
  The Multi-Unit Abutment is a prosthetic device that fits only the endosseous implants specified. The device has been developed for long-term, permanent use.
  Nobel Biocare's Multi-Unit Abutment is similar in design, intended use, and operation to the abultnents cleared in predicate devices.

The provided text is a 510(k) Summary for a dental abutment device. It outlines the device description, indications for use, and a letter from the FDA confirming substantial equivalence. However, it does not include information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory approval based on equivalence to predicate devices, rather than detailed performance study results with acceptance criteria.

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