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FREEPRINT® crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces.
The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.
Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary or permanent dental restorations such as crowns and bridges, inlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary dental restorations.
Restorations fabricated using the Subject device are one-time use, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments.
Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.
The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
The provided document describes the FDA 510(k) premarket notification for the FREEPRINT® crown device, which is a light-cured methacrylate-based resin for 3D printing dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FREEPRINT® crown are primarily based on meeting the requirements of recognized international standards for dental materials. The reported device performance is compared against these standards and against predicate/reference devices.
| Acceptance Criteria (Standard / Parameter) | Performance Criteria | Reported Device Performance (FREEPRINT® crown) |
|---|---|---|
| ISO 4049:2019 (Dentistry — Polymer-based restorative materials) | Meets requirements | Device meets the property requirements |
| ISO 10477:2018 (Dentistry – Polymer-based crown and veneering materials) | Meets requirements | Device meets the property requirements |
| Depth of Cure (ISO 4049 & 10477) | Hardness of bottom surface ≥70% top surface | Meets requirements of ISO 4049 and ISO 10477 |
| Surface Finish (ISO 4049 & 10477) | Glossy surface after polishing | Meets requirements of ISO 4049 and ISO 10477 |
| Flexural Strength (ISO 4049 & 10477) | ≥ 100 MPa | ≥ 100 MPa |
| Water Sorption (ISO 4049 & 10477) | ≤ 40 µg/mm³ | ≤ 40 µg/mm³ |
| Water Solubility (ISO 4049 & 10477) | ≤ 7.5 µg/mm³ | ≤ 7.5 µg/mm³ |
| Biocompatibility (ISO 7405, ISO 10993 series) | Meets requirements | Meets requirements as per testing to listed ISO standards |
| MRI Safety | Supports MR Safety labeling | An MRI safety assessment was performed to support MR Safety labeling |
Note: For several parameters (Depth of Cure, Surface Finish, Flexural Strength, Water Sorption, Water Solubility), the document explicitly states that the FREEPRINT® crown meets the requirements of the listed ISO standards, but for some, it also provides specific values for the subject device or for the predicate/reference devices. The table above uses the explicitly stated acceptance thresholds where given.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of specimens) used for each non-clinical test (e.g., flexural strength, water sorption, biocompatibility). It states that "Physical property testing was performed on the Subject device to ISO 4049:2019...and ISO 10477:2018." These standards typically define the number of test specimens required for various mechanical and physical property evaluations.
Data Provenance: The data is primarily from non-clinical laboratory testing ("Non-clinical Performance Testing") conducted to support the substantial equivalence claim. The country of origin for the testing itself is not explicitly stated, but the manufacturer is DETAX GmbH, located in Germany, suggesting the testing might have been conducted there or in labs compliant with international standards. The document also mentions comparative material property testing performed with a "Reference device," implying some form of internal or contracted testing. This is retrospective data, as it was collected before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is not an AI/Software as a Medical Device (SaMD) that diagnoses or interprets medical images, so the concept of "ground truth" established by experts in a clinical context (e.g., radiologists) is not applicable here. The "ground truth" for this device, which is a dental material, is defined by the objective, quantifiable physical, chemical, and biological properties measured against established international standards (ISO). The "experts" involved would be the material scientists, engineers, and chemists who conducted and interpreted the laboratory tests according to the specified standard operating procedures and test methods. Their specific number and qualifications are not detailed in this FDA letter, but it's presumed they possess the necessary expertise to perform these standardized tests.
4. Adjudication Method for the Test Set
Not applicable. Since the "ground truth" is defined by objective physical and chemical measurements against ISO standards for material performance, there is no need for an adjudication method as would be used in expert consensus for clinical image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document explicitly states: "The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical or animal testing data is included in this submission." Therefore, an MRMC study, which is a type of clinical study, was not performed. The device is a dental material, not an AI or imaging device where MRMC studies are typically relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm. Its performance is measured directly by its physical, chemical, and biocompatibility properties when fabricated into a dental restoration.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements of material properties according to established international consensus standards (ISO standards) for dental restorative materials. These include:
- Physical properties (e.g., flexural strength, water sorption, water solubility, depth of cure, surface finish).
- Chemical characterization of its composition.
- Biocompatibility testing results (cytotoxicity, sensitization, irritation, etc.).
8. The Sample Size for the Training Set
Not applicable. This is a material, not a machine learning algorithm, so there is no concept of a "training set" for an AI model. For material development, batches are produced and tested, but this is part of quality control and R&D, not an "AI training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI model. For the material's development and evaluation, the "ground truth" or acceptable parameters are set by the performance requirements outlined in the relevant ISO standards (e.g., ISO 4049, ISO 10477, ISO 10993 series). These standards represent an international consensus on the minimum performance and safety requirements for such dental materials.
§ 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.