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Indications for Use for Eco Abutment

The Eco Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

Indications for Use for Multiunit Abutment

The Multiunit Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

The Eco Abutment is a two-piece abutment. It consists of a base abutment which is used with temporary post, cemented post, angled post and healing cap. The base abutment is first secured to the dental implant with a base screw and the post is secured to the base abutment with post screw. The Eco Abutment has 4.5, 4.8, 5.5 and 6.5 of diameter and consists of 0, 6, 12 and 18 degree.

The Multiunit Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single unit loading (i.e., crown) or multi-unit loaded restorations (i.e., bridge, bars, overdentures). It is consists of Multiunit Straight Abutment, Multiunit Angled Abutment and Temporary Cylinder. The Multiunit Abutment has 4.8mm of diameter and consists of two kind of design that has three angles. The Multiunit Straight abutment has 0 degree and the Multiunit Angled abutment has 20 or 30 degree

The Eco Abutment and Multiunit Abutment are made from titanium alloy conforming to ASTM F136. It is provided non-sterile and is steam sterilized before use.

Non-Hex connection abutments are intended for multi-unit restorations only.

The provided text is a 510(k) summary for dental implant abutments, focusing on regulatory approval based on substantial equivalence to predicate devices. It does not contain information about a clinical study with acceptance criteria for device performance relevant to AI/ML devices or studies involving human readers.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size, or improvement with AI assistance.
• Standalone performance (algorithm only).
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing (sterilization validation, biocompatibility, mechanical properties, MR environment condition) to demonstrate substantial equivalence to existing predicate devices, which is a common pathway for medical device clearances that do not involve AI/ML components or comparative effectiveness studies with human readers. The document explicitly states "No clinical studies are submitted."

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