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NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with

NobelParallel™ Conical Connection (herein referred to as NobelParallel™ CC) implants are threaded, root-form, endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore a patient's chewing function.

The sterile, single-use only implants, made of commercially pure titanium (ASTM F67-13), range in length from 6.5 – 17.5 mm (physical implant length) and are provided in four (4) diameters (Ø 3.75 mm, 4.3 mm, 5.0 mm, and 5.5 mm). The implants feature a conical connection which is compatible with Nobel Biocare's narrow platform (NP), regular platform (RP), and wide platform (WP) abutments. The conical connections are color coded to identify the compatible abutment platform(s).

Each implant is individually packaged and provided with its corresponding titanium alloy cover screw (Ti-6Al-4V, per ASTM F136-13 and ISO 5832-3).

The provided text is a 510(k) Summary for a medical device called NobelParallel™ Conical Connection implants. It describes the device, its intended use, comparison to predicate devices, and performance data provided for substantial equivalence determination.

Here's a breakdown of the requested information based on the provided text. Please note that the document is a summary and therefore may not contain all the granular details of a full study report.

Acceptance Criteria and Device Performance

This document does not explicitly state acceptance criteria in a quantitative table format with corresponding device performance values. Instead, it describes differences and similarities to predicate devices and lists the types of studies performed to support substantial equivalence. The implication is that the device's performance, as demonstrated by these studies, met the FDA's criteria for substantial equivalence to existing legally marketed devices.

However, based on the performance data listed, we can infer the types of performance evaluated:

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