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• Direct restoration of Class I V cavities (acc. to G.V. Black) .
• . Direct composite veneers
• Shape corrections of teeth (i.e. diastemas, congenital defects in teeth etc.) .
• Splinting of teeth loosened by trauma or periodontal disease .
• . Indirect restorations (inlays, veneers)
• Restoration of primary teeth .
• Core build-up .
• Repairs of porcelain, composite (in combination with an adequate repair . system)

Venus Pearl is a, universal light-curing, radio-opaque nano-hybrid composite for antenor and posterior use. Due to the excellent material properties, a beautiful aesthetic result and a durable, high lustre polish is easily reached. Nano hybrid composite contain a blend of small particle fillers and large particle fillers that create durable and aesthetic restorations. The nano fillers panide micro that croate darable of the filler content and provide the natural aesthetic appearance. It is used as a base in Class I -- V restorations and can be placed in increments it is used as a base in Glass in Glass in othersal shades and special shades, 3 mm for the core-build-up shade and 1 mm for opaque-shades. Venus Pearl is used following the application of a dentin/enamel addlesive (e.g. Venus Fear is used lollowing the upper for use with light cured composite restorations. Venus Pearl is based on 2-Propenoic acid, (octahydro-4,7-methano-1Hindenes / Carrie bleneiminocarbonyloxy-2- , 1-ethanediy()ester (TCD-Dlindene-5-dify)blo(methyl-4,13-dioxo-3,14-dioxe-5,12-diazahexadecane-1,16diy-dimethacrylate (UDMA) (approximately 59% filler by volume, with 58% anorganic filler by volume, Banum aluminium Fluoride glass, pre-polymerized filler and highly discrete nanoparticles . The filler particle size is between 5 nm and 5 um

This document describes the 510(k) submission for the dental restorative material "Venus Pearl." Since this is a submission for a restorative material and not a medical device with an algorithm or AI component, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details for AI) are not applicable.

The acceptance criteria here refer to the product's compliance with established standards for dental materials. The study proving this compliance is primarily based on non-clinical testing and comparison to an equivalent predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document is for a dental restorative material, not an AI or algorithm-based device that would typically have a "test set" in the context of data analysis. The testing for Venus Pearl involved in-vitro physical property tests and biocompatibility tests, not data sets in the traditional sense for algorithm evaluation. The document does not specify the number of material samples used for these tests. Data provenance is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As above, a "test set" in the computational context does not apply here. Ground truth for material properties is established through standardized laboratory testing protocols, not expert consensus on images or diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No adjudication method is described, as there is no diagnostic test set requiring expert review.

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

• Not Applicable. This is not an AI-assisted device, so no MRMC study or AI-related effectiveness metrics are relevant.

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

• Not Applicable. This is not an algorithm-only or AI device.

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

• The "ground truth" for the performance of Venus Pearl is based on:
  • Standardized Physical Property Measurements: Adherence to defined thresholds and methodologies outlined in international standards like EN ISO 4049.
  • Biocompatibility Testing: Results from established in-vitro and in-vivo toxicology tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 standards.
  • Clinical Evaluation: A literature review and risk assessment process (MEDDEV 2.7.1, EN ISO 14971) comparing the new device's characteristics and intended use to known performance and safety data of similar, well-established restorative materials (like the predicate device, Venus Diamond). This is effectively a "retrospective" clinical evaluation drawing on existing knowledge and safety profiles of the material class, rather than new prospective clinical trials for this specific submission for a similar device.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML product.

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

• Not Applicable. No training set exists.

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