(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.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.