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PermaCem is a chemical cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays.

PermaCem Dual is a dual cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays.

PermaCem and PermaCem Dual can also be used for:

• Luting of orthodontic anchors and brackets
• Luting of abutments for dentures
• Core build-up
• Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
• Repair material for resin-based provisionals
• Bite registration material
• Occlusal individualisation of plastic bite rails

PermaCem: PermaCem is a chemical-curing, radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other.

PermaCem Dual: PermaCem Dual is a dual cure (chemical and/or light cure), radiopaque two-component luting material available in automix delivery systems or as a handmix material, designed for the permanent luting of metals, ceramics, and resin-based materials, which may be luted to tooth structures or in various combinations to each other.

This document is a 510(k) Pre-market Notification for the PermaCem and PermaCem Dual dental luting materials. It is an "Abbreviated 510(k)" which relies on compliance with recognized FDA guidance documents and international standards rather than extensive de novo studies. Therefore, much of the requested information regarding a specific device performance study and acceptance criteria in the traditional sense is not directly provided in this submission summary.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the submission is an "Abbreviated 510(k)" demonstrating conformity with:

• FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998
• ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.

Therefore, the acceptance criteria are implicitly the performance requirements specified within these standards and guidance documents for dental luting materials. The "reported device performance" is the claim by the sponsor that the devices conform to these criteria, which then supports the claim of substantial equivalence.

Since specific quantitative acceptance criteria or direct performance results (e.g., bond strength values, setting times) are not explicitly listed in the provided text, a table cannot be fully populated from this document. However, the nature of the submission (Abbreviated 510(k)) indicates that the device's performance meets the standard requirements from ISO 4049 and FDA guidance for similar devices.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified in the provided text.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies referenced would be those conducted to demonstrate compliance with ISO 4049 and FDA guidance, but details are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable and not provided. An Abbreviated 510(k) for a dental luting material would typically involve laboratory testing against established physical and chemical properties, not human interpretation of data requiring "ground truth" derived from experts in the clinical sense.

4. Adjudication method for the test set

• Not applicable and not provided. The compliance would be based on objective laboratory measurements against set standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable to an Abbreviated 510(k) for a dental luting material. This type of study is relevant for diagnostic imaging AI devices, not for dental cements.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a dental luting material, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this type of device would be the established physical and chemical properties required by ISO 4049 and FDA guidance for dental cements, such as bond strength, setting time, solubility, radiopacity, and biocompatibility. This "ground truth" is determined through laboratory testing methods outlined in the standards, not expert consensus or pathology in a diagnostic sense.

8. The sample size for the training set

• Not applicable. This device is a dental luting material, not an AI system that requires training data.

9. How the ground truth for the training set was established

• Not applicable. This device is a dental luting material, not an AI system.

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