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TDS Abutment for Nobel Biocare Replace is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

TDS Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.

Note: Highly angled abutments (i.e. 30°) on implants with diameters less than 4 mm are not intended for the posterior region of the mouth due to limited strength of the implant.

TDS Abutment for Nobel Biocare Replace are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Nobel Biocare Replace are compatible with Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.

This document is a 510(k) Premarket Notification for a dental implant abutment (TDS Abutment for Nobel Biocare Replace). It is a regulatory submission to demonstrate substantial equivalence to legally marketed predicate devices, not a study reporting on the performance of the device against specific acceptance criteria.

Therefore, the requested information (acceptance criteria, device performance, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set information) is not present in the provided text.

The document primarily focuses on:

• Administrative Information: Manufacturer, contact, device names, classification.
• Intended Use: What the device is designed for.
• Device Description: Materials, compatibility with specific implant systems.
• Equivalence to Marketed Device: Asserting substantial equivalence to existing predicate devices.
• FDA Communication: A letter from the FDA affirming the substantial equivalence determination and outlining regulatory obligations.
• Indications for Use: Formal statement of the device's indications.

The FDA's substantial equivalence determination means they believe the new device is as safe and effective as a legally marketed predicate device, not that specific performance metrics against an acceptance criterion were reported in this submission or that a large-scale clinical study was conducted. For this type of device, substantial equivalence is often established through material testing, mechanical testing, and comparison of design features and intended use to predicate devices, rather than through extensive clinical trials with detailed performance metrics like sensitivity/specificity.

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