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The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.

The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are components used with various BRANEMARK SYSTEM® Wide Platform Fixtures. They include Abutments, Healing Abutments, Hand Instruments, Impression Copings and Machine Instruments.

This document is a 510(k) summary for a medical device submitted in 1996. It does not contain any information about acceptance criteria, device performance, results of any studies, or ground truth establishment.

The document is a pre-market notification that primarily focuses on:

• Device Name and Manufacturer: Nobelpharma USA, Inc.
• Device Description: Accessories for the BRANEMARK SYSTEM® - Wide Platform Fixtures (e.g., Hand Instruments, Healing Abutments, Impression Copings, Machine Instruments).
• Predicate Product: Other existing components marketed by Nobelpharma.
• Intended Use: To be used as accessories with the Wide Platform endosseous implant system, in the same manner as predicate products.
• Comparison of Technological Characteristics: States that the technological characteristics are "identical" to the corresponding predicate products.

Therefore, I cannot provide the requested information as it is not present in the provided text.

To answer your questions, I would need a document that describes the design verification and validation testing performed for the device, including:

• Specific acceptance criteria (e.g., tensile strength, dimensional accuracy, sterilization efficacy).
• Results of tests demonstrating compliance with these criteria.
• Details about the study design (e.g., sample sizes, methods for establishing ground truth, expert qualifications, adjudication methods).

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