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510(k) Data Aggregation
(93 days)
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
- Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
- Indirect anterior and posterior restorations including inlays, onlays and veneers
- Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
- Splinting
els extra low shrinkage® flow is indicated for:
- Restorations with minimally invasive preparation technique
- Restorations of small cavities and extended fissure sealing
- Alternate restorations for undercut cavities
- Restorations of class III V including wedged shaped defects and cervical caries
- Repair of fillings, veneers and methacrylate-based temporary restorations
- First layer of fillings for Class I and II
- Interlocking of loosened teeth
- Adhesive attachment of indirect composite and ceramic restorations
els extra low shrinkage® composite is classified as a Type 1, Class 2, Group 1 & 2 Polymerbased restorative material according to ISO 4049:2009 - Dentistry - Polymer-based restorative materials.
els extra low shrinkage® flow is classified as Type 2, Class 2, Group 1 Polymer-based restorative material according to ISO 4049:2009 – Dentistry – Polymer-based restorative materials.
els extra low shrinkage® composite & els extra low shrinkage® flow are light-cured methacrylate-based resins that are intended to fill and restore small to large defects or carious lesions in teeth.
els extra low shrinkage® composite & els extra low shrinkage® flow are light cured radiopaque microhybrid composites with extremely low shrinkage stress.
This document is a 510(k) summary for the "els extra low shrinkage® composite" and "els extra low shrinkage® flow" dental restorative materials. It does not describe a study involving an AI/software device that requires intricate details on acceptance criteria and performance evaluation against a defined ground truth. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance (bench testing) and material comparison.
Therefore, many of the requested categories for AI/software studies are not applicable to the information provided in this document.
However, I can extract the information that is relevant to the non-clinical performance and acceptance criteria for these dental materials:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for "els extra low shrinkage® composite" and "els extra low shrinkage® flow" are based on meeting the requirements of the ISO standard ISO 4049:2009 - Dentistry - Polymer-based restorative materials. The tables below show a comparison of the device's physical properties against predicate devices, indicating that the device performance meets these standards.
els extra low shrinkage® composite (els composite) Performance vs. Predicate Devices
| Attribute | Acceptance Criteria (Implied by ISO 4049 & Predicate Range) | els composite Reported Performance | Denomination of acceptance range compliance (Pass/Fail) |
|---|---|---|---|
| Compressive Strength | Met by ISO 4049 (Predicate: 187.4-285 MPa) | Avg. = 289.8 MPa | Pass (Higher strength does not affect substantial equivalence) |
| Surface Hardness | Met by ISO 4049 (Predicate: 43.86 KHN - Unknown) | Avg. = 76 Vicker's Hardness | Pass (Typical standard for composites) |
| Flexural Strength | Met by ISO 4049 (Predicate: 125.4-135.74 MPa) | Avg. = 116.3 MPa | Pass (Meets same ISO 4049 performance requirements) |
| Water Sorption | Met by ISO 4049 (Predicate: 18.2-18.48 µg/mm3) | Avg. = 14.7 µg/mm3 | Pass (Meets same ISO 4049 performance requirements) |
| Solubility | Met by ISO 4049 (Predicate: 0.3-0.82 µg/mm3) | Avg. = 0.8 µg/mm3 | Pass (Meets same ISO 4049 performance requirements) |
| Depth of Cure | ≥ 1.5 mm | ≥ 1.5 mm | Pass |
| Radiopacity | Met by ISO 4049 (Predicate: 3.2 mm Al) | Avg. = 2.8 mm Al | Pass (Meets same ISO 4049 performance requirements) |
els extra low shrinkage® flow (els flow) Performance vs. Predicate Devices
| Attribute | Acceptance Criteria (Implied by ISO 4049 & Predicate Range) | els flow Reported Performance | Denomination of acceptance range compliance (Pass/Fail) |
|---|---|---|---|
| Compressive Strength | Met by ISO 4049 (Predicate: 332-415 MPa) | Avg. = 225.1 MPa | Pass (Suitable for small cavities, not requiring higher strength) |
| Surface Hardness | Met by ISO 4049 (Predicate: Unknown) | Avg. = 55 Vicker's Hardness | Pass (No available data to compare with) |
| Flexural Strength | Met by ISO 4049 (Predicate: 96-117 MPa) | Avg. = 116.5 MPa | Pass (Meets same ISO 4049 performance requirements) |
| Water Sorption | Met by ISO 4049 (Predicate: ≤40 - 23 µg/mm³) | Avg. = 19.0 µg/mm³ | Pass (Meets same ISO 4049 performance requirements) |
| Solubility | Met by ISO 4049 (Predicate: ≤ 7.5 - 2.0 µg/mm³) | Avg. = 1.5 µg/mm³ | Pass (Meets same ISO 4049 performance requirements) |
| Depth of Cure | ≥ 1.5 mm | ≥ 1.5 mm | Pass |
| Radiopacity | Met by ISO 4049 (Predicate: 3.1 - 2.2 mm Al) | Avg. = 1.3 mm Al | Pass (Meets same ISO 4049 performance requirements) |
The following points are not applicable as this submission is for dental restorative materials, not an AI/software device. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of els extra low shrinkage® composite & els extra low shrinkage® flow."
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable (no human clinical test set).
- 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 (ground truth not established by experts as there are no human clinical outcomes).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable (ground truth is derived from compliance with ISO standards for physical and chemical properties).
- The sample size for the training set: Not applicable as there is no training set for an AI/software device. The product underwent non-clinical bench testing.
- How the ground truth for the training set was established: Not applicable.
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(50 days)
Extended fissure sealing First-layer lining for class I and class II cavities Class I, II, III and V direct restorations Repair of direct and indirect restorations in combination with a suitable adhesive Splinting loosened teeth resulting from trauma or periodontal associated events
Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite. The uncured dental composite is introduced into the oral cavity to be applied and cured to the tooth structure or restoration pre-treated by the dentist, thus achieving the clinical benefit.
The provided text describes the regulatory submission for the Venus Bulk Flow ONE, a dental restorative material. It focuses on demonstrating substantial equivalence to a predicate device (Venus Diamond Flow, K091635) primarily through non-clinical bench testing. There is no information regarding AI/ML device acceptance criteria or performance.
Here's the breakdown of the information requested, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Parameter | Required Specification (Acceptance Criteria per ISO 4049:2019) | Reported Device Performance (Venus Bulk Flow ONE) |
|---|---|---|
| Sensitivity to dental OP light | > 60 s | Exceeded specification (results equal or better than predicate) |
| Depth of cure | > 1.5 mm | Achieved 4 mm (predicate device was 2 mm) |
| Flexural strength | > 80 MPa | Exceeded specification (results equal or better than predicate) |
| Water sorption | < 40 µg/mm³ | Exceeded specification (results equal or better than predicate) |
| Water solubility | < 7.5 µg/mm³ | Exceeded specification (results equal or better than predicate) |
| Color stability | No more than slight change in color | Exceeded specification (results equal or better than predicate) |
| Radio-opacity | > 100%-Al and SD < 50%, if claimed | Exceeded specification (results equal or better than predicate) |
2. Sample sized used for the test set and the data provenance:
The document describes non-clinical bench testing according to ISO 4049:2019. It does not specify sample sizes for these tests. The data provenance is from internal studies conducted by Kulzer, LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for this device is based on objective, quantifiable physical and chemical properties measured through laboratory bench testing according to international standards (ISO 4049:2019), not expert consensus.
4. Adjudication method for the test set:
Not applicable. The "test set" here refers to material samples undergoing laboratory characterization against predefined ISO 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:
Not applicable. This is a dental restorative material, not an AI/ML diagnostic or assistive device. There were no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental restorative material, not an AI/ML algorithm.
7. The type of ground truth used:
The ground truth used for demonstrating device performance is based on the specified requirements of international standard ISO 4049:2019 for polymer-based restorative materials. These are objective, measurable physical and chemical properties.
8. The sample size for the training set:
Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set. The "development" of the product involved modification of materials and composition, not training of an algorithm.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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