Search Results
Found 189 results
510(k) Data Aggregation
(56 days)
: K253365**
Trade/Device Name: LuxCreo Flexible Partial Denture Resin
Regulation Number: 21 CFR 872.3760
Regulation Description: Denture relining, repairing, or rebasing resin
Regulation Number: 21 CFR 872.3760
Regulation Number: 21 CFR 872.3760
Device Class: Class II
Product Code: EBI
510(k) Number: K250617
Regulation Number: 21 CFR 872.3760
Device Class: Class II
Product Code: EBI
510(k) Number: K250489
LuxCreo Flexible Partial Denture Resin is a liquid light-curing resin indicated for the fabrication and repair of partial denture bases. It is intended for use by dental professionals in dental and orthodontic laboratories and clinics.
LuxCreo Flexible Partial Denture Resin is intended for the additive manufacturing of removable partial denture bases, including denture bases for interim and transitional dentures, for the replacement of one or more missing teeth. The device is supported by remaining natural dentition and oral tissues. Partial dentures manufactured using this resin may be used permanently as a total removable replacement or temporarily while the patient is preparing for permanent implant.
LuxCreo Flexible Partial Denture (FPD) Resin is a state of the art resin engineered specifically for the 3D Printing of digitally designed flexible partial denture bases. The FPD resin utilizes LuxCreo's Digital Polishing platform to deliver clear, accurate, and biocompatible partial dentures in a single session with minimal need for finishing.
N/A
Ask a specific question about this device
(51 days)
China
Re: K253324
Trade/Device Name: UltraPrint-Dental Denture UV
Regulation Number: 21 CFR 872.3760
Regulation Name: Denture relining, repairing, or rebasing resin
Regulation Number: 21 CFR 872.3760
Repairing, Rebasing | Resin, Denture, Relining, Repairing, Rebasing | Same |
| Regulation Number | 21 CFR 872.3760
| 21 CFR 872.3760 | Same |
| Regulatory Class | Class II | Class II | Same |
| Intended use | UltraPrint-Dental
UltraPrint-Dental Denture UV is indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.
UltraPrint-Dental Denture UV is intended for continuous use in the oral environment, exclusively for professional dental work.
UltraPrint-Dental Denture UV can be used in combination with a 3D printer using a 385nm light source. A 3D-printer is not part of the device.
The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of full or partial denture base. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of full or partial denture base.
The Subject device is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are prescription-only devices.
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 3D printers and their nesting software, and post-curing devices.
N/A
Ask a specific question about this device
(90 days)
Michigan 48105
Re: K252430
Trade/Device Name: Freeprint® denture flex
Regulation Number: 21 CFR 872.3760
Regulation Name: Denture relining, repairing, or rebasing resin
Regulation Number: 21 CFR 872.3760
K213994 | K232448 |
| Product Code | EBI | EBI | EBI, MQC | MQC, KMY |
| Regulation | 21 CFR 872.3760
| 21 CFR 872.3760 | 21 CFR 872.3760 | Unclassified |
| Intended Use | Used in the fabrication of
The Freeprint® denture flex is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment. The Freeprint® denture flex is indicated for the fabrication, by additive manufacturing, of dental objects such as flexible partial removable dentures.
Freeprint® denture flex is a light-cured, 3D printed flexible denture resin. The Subject device is used by a dental professional (dentist or dental technician) in the CAD/CAM manufacturing of patient-specific partial dentures. There are two models of the Subject device which are referred to as Freeprint® denture flex clear and Freeprint® denture flex pink-transparent. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigment and is provided in an HDPE bottle.
The Subject device resin is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are one-time use, prescription-only devices.
N/A
Ask a specific question about this device
(0 days)
. |
| Classification | 21 CFR 872.3690 21 CFR 872.3770 | 21 CFR 872.3690 21 CFR 872.3770 21 CFR 872.3760
G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.
G-BLOCK is a compact block made of graphene-doped polymer suitable for the manufacture of dental prostheses using CAD/CAM technology. The polymer is based on polymethyl methacrylate (PMMA) doped with graphene (an allotrope of carbon).
G-BLOCK is intended to be used for the fabrication of permanent and temporary restorations such as dental implant prostheses, crowns, bridges, inlays, onlays and veneers.
G-BLOCK, compounded of polymethyl methacrylate (PMMA) doped with Graphene, is manufactured using the heat-curing method.
G-BLOCK presents high modulus and elastic limit to ensure that the tensions generated during biting and chewing do not cause permanent deformations, and it is possible to manufacture prosthesis of smaller sections.
G-BLOCK presents high deformation resistance and stress limit, thus avoiding the formation of cracks and fractures.
G-BLOCK is low density making the prosthesis lightweight.
G-BLOCK increases the material hardness comparing with acrylic resins used in dentistry.
G-BLOCK has colour stability.
G-BLOCK has wide chromatic range, even within the same piece, making it look extremely natural.
G-BLOCK is chemically inert.
G-BLOCK water absorption is 4 μg/mm³ and a solubility of 0.5 μg/mm². The release of residual monomer is minimum, with a percentage of 0.004% of residual monomer. Thanks to these physical properties G-BLOCK offers a durable and safety treatment.
G-BLOCK is available in different formats, sizes and colors, having all variations the same physicochemical characteristics.
The device is presented in the form of a polymer block glued to an aluminum pin that allows the device to be fixed on the milling machine so that the block can be milled to obtain dental prostheses with the use of specific CAD/CAM equipment.
G-BLOCK is available in 2 different formats: MONOCHROMA and MULTICHROMA. Monochrome and Multichroma blocks may be both used for anatomical monolithic restorations.
When machined, Monochroma and Multichroma present a different visual effect:
-
Monochroma, is made of a pure colour matching the dentin.
-
Multichroma, has a chromatic spectrum based on the natural colour imitating the optical effects of the natural dentition.
Both variants are presented in two sizes: 14 and 40.
G-BLOCK device is available in the following colours, A1, A2, A3, A3.5, B1, B2, BL1, BL2, C2 (according to G-CAM shade guide).
G-BLOCK are provided non-sterile and as a single use device.
G-BLOCK must be used only by professionals as dental lab technicians and / or dentist.
G-BLOCK should be stored at room temperature in its original packaging, in dry storage and avoid exposure to direct sunlight. PMMA polymer from which the G-BLOCK is made is stable and can be stored for an extended period of 5-year shelf life.
N/A
Ask a specific question about this device
(79 days)
DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)
Regulation Number: 21 CFR 872.3760
Classification Name | Resin, Denture, Relining, Repairing, Rebasing |
| Regulation Number | 872.3760
It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions.
DENTURE SOFT EX is a soft lining material for removable dentures.
It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions.
The device consists of powder and liquid. The powder contains acrylic polymer (POLY (ETHYL METHACRYLATE)) and others. The liquid contains plasticizer, ethanol and others.
The powder and liquid are mixed when it is used and starts gelation, forms soft acrylic resin.
N/A
Ask a specific question about this device
(142 days)
California 92612
Re: K250302
Trade/Device Name: Flexible Partial Resin
Regulation Number: 21 CFR 872.3760
Classification Name: Denture relining, repairing, or rebasing resin
Regulation Number: 872.3760
Appliance Resin | N/A |
| 510(k) | (K050302) | (K213994) | (K223798) | N/A |
| Regulation | 21 CFR 872.3760
| 21 CFR 872.3760 | N/A | Same |
| Product Code | EBI | EBI, MQC | MQC, KMY | Additional product MQC
Flexible Partial Resin is indicated for the fabrication of dental appliances such as dental plates, bite plates, partial denture frame-works and clasps.
The subject device, Flexible Partial Resin, is a light-cured polymerizable resin for the fabrication of partial removable denture bases made in dental laboratories. The resin can be used in DLP printers utilizing a wavelength of 385nm and will be offered in G1 (standard pink), G3 (medium pink), and G4 (dark pink) shades formulated to match gingival tissue. The final medical device is a custom fitted appliance that is compliant to the dental professional's diagnosis and prescription.
The provided document is a 510(k) clearance letter for a dental resin, not a study report for an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for device performance as it pertains to an AI/ML device.
The document discusses the substantial equivalence of a new dental resin (Flexible Partial Resin) to a predicate device (Flexible Block) based on:
- Indications for Use Comparison: Both devices are indicated for fabricating dental appliances such as dental plates, bite plates, partial denture frameworks, and clasps. The predicate has additional indications not claimed by the subject device.
- Technological Comparison: The devices are compared based on material composition and principle of operation. The subject device uses a methacrylate/dimethacrylate-based resin and 3D printing (DLP), while the predicate uses polyamide and milling from blocks.
- Performance Testing: Non-clinical tests were conducted to compare the physical properties of the subject device to the predicate device using ASTM standards (Flexural Strength and Modulus, Tensile Strength, Elongation at Break, Impact Strength, Water Absorption). Printing accuracy was also tested.
- Biocompatibility: The subject device was evaluated per ISO 10993-1:2018, leveraging data from a reference device.
Key takeaway for your request:
The FDA 510(k) clearance letter for "Flexible Partial Resin" does not describe an AI/ML device or a study involving AI/ML performance. Therefore, it does not contain information about:
- Acceptance criteria and performance for an AI/ML device.
- Sample sizes for test sets, data provenance, or ground truth establishment relevant to AI/ML.
- Number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML.
- Training set size or ground truth for an AI/ML model.
This document is for a material used in dental device fabrication, not an AI-powered diagnostic or assistive tool.
Ask a specific question about this device
(253 days)
Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional splints or night guards.
Partial Flex® dental resin is a polymer base material used for the fabrication of partial removable dentures and prosthesis. Partial Flex is made from a resin of polypropylene that is designed and manufactured for injection molding. Partial Flex® is available in two shades as a granular material (so-called pellets) contained in an aluminum tube with 27 g or in a plastic bag of 250 g. In addition to high biocompatibility, Partial Flex® material features hypoallergenic properties, no risk of discoloration and the dental prosthesis made are unbreakable, which differentiates the from acrylic materials. The resin material is pigmented in one color and without pigment presentation: Light pink and Natural color (without pigment).
The provided FDA 510(k) Clearance Letter for the device "Partial Flex" does not describe acceptance criteria, the study that proves the device meets acceptance criteria, or any details about AI/human reader studies.
The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device. It confirms that the device is a "Denture Relining, Repairing, Or Rebasing Resin" and lists some non-clinical performance tests conducted to show compliance with ISO standards (ISO 20795 and ISO 10993 for biocompatibility), but it does not provide specific acceptance values or the actual results of these tests beyond "passed the acceptance criteria" or "complies with the requirements."
Therefore, it's impossible to fill in the requested information based solely on the provided text. The prompt asks for details that are typically found in a clinical study report or a more detailed section of a 510(k) submission, neither of which is present in the provided clearance letter.
However, I can illustrate what a hypothetical response would look like if the information were available, using the structure of your request.
Hypothetical Response (Illustrative, as the provided document lacks the necessary data):
This document, an FDA 510(k) Clearance Letter, primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It details non-clinical performance testing but does not contain the specific acceptance criteria, detailed study results, or information pertaining to AI performance, human reader studies, or ground truth establishment that would be required to fully answer the prompt. The information below is hypothetical and structured as if the data were present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|
| Material Properties (per ISO 20795) | (Stated in document as "The material complies with the requirements" or "passed the acceptance criteria") |
| Ultimate Flexural Strength: > X MPa | Y MPa (Meets requirements) |
| Flexural Modulus: > A GPa | B GPa (Meets requirements) |
| Sorption: < C µg/mm² | D µg/mm² (Meets requirements) |
| Solubility: < E µg/mm² | F µg/mm² (Meets requirements) |
| Color Stability: Pass visual inspection after accelerated aging | Passed (Complies with requirements) |
| Freedom from Porosity: No visible pores greater than G mm | Complies with requirements |
| Biocompatibility (per ISO 10993) | |
| Intracutaneous Injection Test: No significant irritation | Passed Acceptance Criteria |
| Kligman Maximization Test: Non-sensitizing | Passed Acceptance Criteria |
| L929 MEM Elution Test: Non-cytotoxic | Passed Acceptance Criteria |
| (If AI-related: Performance Metric 1, e.g., Accuracy) | (If AI-related: 95% CI of Metric 1, e.g., 92% (90-94%)) |
| (If AI-related: Performance Metric 2, e.g., Sensitivity) | (If AI-related: 95% CI of Metric 2, e.g., 88% (85-91%)) |
| (If AI-related: Performance Metric 3, e.g., Specificity) | (If AI-related: 95% CI of Metric 3, e.g., 95% (93-97%)) |
(Note: The provided document states "The material complies with the requirements" or "passed the acceptance criteria" without specifying the numerical values for the criteria themselves or the actual measured performance values. For example, under "Ultimate Flexural Strength," it only says "The material complies with the requirements." It does not give a specific threshold like "Ultimate Flexural Strength > 65 MPa" and then a result like "72 MPa".)
2. Sample Sizes and Data Provenance
The provided document describes non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests, nor does it refer to patient data (e.g., medical images, clinical outcomes) that would typically have provenance data.
- Test Set Sample Size: Not applicable/Not specified in the provided document for human data or AI model evaluation. For bench tests, typical sample sizes are per ISO standards but not detailed here.
- Data Provenance: Not applicable for the type of testing described (bench and biocompatibility). No mention of country of origin or retrospective/prospective data collection.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The provided document describes material testing and biocompatibility. It does not involve human readers, clinical data interpretation, or AI ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. No expert review or clinical test set adjudication is described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a material science device (dental resin), not a diagnostic imaging or AI-assisted interpretation device. No MRMC study was performed or is relevant to this device's 510(k) submission as described.
6. Standalone Algorithm Performance
Not applicable. This device is a physical dental resin, not an algorithm or software.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests described in the document (material properties and biocompatibility) would be based on:
- Established ISO Standards (e.g., ISO 20795 for dental base polymers, ISO 10993 for biocompatibility): These standards define the test methodologies and acceptable performance limits.
- Laboratory Measurements and Biological Assays: Objective, quantitative measurements performed in a laboratory setting (e.g., measuring flexural strength, assessing cell viability, observing tissue reactions in animal models).
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this 510(k) submission.
8. Sample Size for the Training Set
Not applicable. This device is a manufactured resin, not an AI model requiring a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. This device is a manufactured resin, not an AI model.
Ask a specific question about this device
(90 days)
Gibbstown, New Jersey 08027
Re: K250489
Trade/Device Name: FP3D
Regulation Number: 21 CFR 872.3760
Classification Name | Resin, Denture, Relining, Repairing, Rebasing |
| Regulation Number | 872.3760
FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.
The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients.
Acceptance Criteria and Device Performance for FP3D
This document analyzes the provided FDA 510(k) Clearance Letter (K250489) for the FP3D device to detail its acceptance criteria and the studies that prove its compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details non-clinical performance testing against specific ISO and ASTM standards. The acceptance criteria are implicitly defined by these standards, and the "reported device performance" is the conclusion that the device "meets the requirements" or "was completed per" these standards. Specific numerical values for the performance are not provided in this summary.
| Acceptance Criteria (Standard Reference and Property) | Reported Device Performance (Summary) |
|---|---|
| Physical Properties | |
| ISO 20795-1:2013 - Colour stability | Testing completed per standard, indicating compliance. |
| ISO 20795-1:2013 - Ultimate Flexural Strength | Testing completed per standard, indicating compliance. |
| ISO 20795-1:2013 - Flexural Modulus | Testing completed per standard, indicating compliance. |
| ISO 20795-1:2013 - Water sorption | Testing completed per standard, indicating compliance. |
| ISO 20795-1:2013 - Water solubility | Testing completed per standard, indicating compliance. |
| ASTM D348 (tensile properties) | Additional performance testing completed per standard. |
| ASTM D790 (flexural modulus) | Additional performance testing completed per standard. |
| Biocompatibility | |
| ISO 10993 (biocompatibility for permanent device, mucosal membrane contact) | Confirmed biocompatible and meets requirements for a permanent (>30 days) device in contact with the mucosal membrane. |
Note: The FDA 510(k) summary typically summarizes the results rather than providing raw data or specific passing/failing values for each test. The statement "completed per" or "meets the requirements" implies that the device satisfied the acceptance criteria of the respective standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample sizes used for the physical and biocompatibility tests. It only states that "Nonclinical performance testing was conducted."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were conducted retrospectively or prospectively. Given the nature of these tests (material properties and biocompatibility), they are typically conducted prospectively in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to the provided extract. The tests described (physical properties and biocompatibility) are objective, laboratory-based evaluations against established international standards (ISO, ASTM). They do not involve interpretation by human clinicians or the establishment of "ground truth" by experts in the same way clinical diagnostic studies do. The standards themselves define the "ground truth" for performance.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Laboratory tests against standards do not typically involve adjudication methods like 2+1 or 3+1, which are characteristic of expert review for clinical judgments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: Not Applicable." The device is a material for fabricating dentures, not a diagnostic imaging or AI-assisted diagnostic tool that would typically involve a multi-reader study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The FP3D is a material (resin) for 3D printing, not an algorithm or software device. Therefore, a standalone performance study for an algorithm is not relevant here.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance tests was established by international standards and regulations:
- For physical properties: ISO 20795-1:2013 (Dentistry - Base polymers - Part 1: Denture base polymers), ASTM D348 (tensile properties), and ASTM D790 (flexural modulus).
- For biocompatibility: ISO 10993.
These standards define the acceptable range or criteria for the properties being tested.
8. Sample Size for the Training Set
This information is not applicable. The FP3D is a material (resin), not a machine learning model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
Ask a specific question about this device
(69 days)
Classification name:** Material, Tooth Shade, Resin
Production code: EBF
Regulation number: 21 CFR 872.3760
Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-cured resin indicated for the fabrication of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges.
Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-curing, hybrid dental material, composed of methacrylic acid esters, inorganic filler, photoinitiator, organic pigments, inorganic pigments and additives. It is Liquid resin for dental 3D printing of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. For use in Digital Light Processing (DLP)- 3D printers utilizing wavelengths at 385nm or 405nm.
The Subject device is packaged in black plastic bottles made of high density polyethylene (HDPE) according to the weight of the resin liquid.
There are different shades A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, BL1, BL2, BL3, BL4, and the different shades are reflected in the different colors of finished restorations.
The provided FDA 510(k) clearance letter and summary describe a dental resin, not an AI/software as a medical device (SaMD). Therefore, the information required for explaining AI/SaMD acceptance criteria and studies (such as diagnostic performance metrics, reader studies, ground truth establishment, training/test set details, etc.) is not present in this document.
The document focuses on the physical, mechanical, and biocompatibility properties of a dental manufacturing resin. As such, I cannot extract the requested information regarding AI/SaMD performance studies from this provided text.
Here's a breakdown of why the requested information cannot be provided based on the input:
- Device Type: The device, "Additive Manufacturing (Light Curing) Crown Bridge Resin," is a material used for 3D printing dental restorations. It is not an AI algorithm or software.
- Study Type: The studies performed are bench tests (
Non-clinical Test Conclusion) evaluating material properties (e.g., flexural strength, water sorption, biocompatibility) against established ISO standards, and shelf-life testing. These are not studies to prove the performance of an AI model. - Acceptance Criteria & Performance: The acceptance criteria are explicitly tied to physical and mechanical properties (e.g., Flexural Strength ≥ 50 MPa as per ISO 10477:2020), not diagnostic accuracy or other AI-related metrics.
- Missing Information Related to AI/SaMD: All specific points requested in your prompt (sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, effect size) are entirely absent because they are not applicable to the clearance of a dental resin material.
In summary, the provided document does not contain the information necessary to describe the acceptance criteria and study that proves an AI/SaMD device meets its acceptance criteria. The document pertains to a physical dental material, not an artificial intelligence product.
Ask a specific question about this device
(60 days)
California 90065
Re: K250617
Trade/Device Name: Apex Flex
Regulation Number: 21 CFR 872.3760
Date Prepared: March 14, 2025
Trade/Device Name: Apex Flex
Regulation Number: 21 CFR 872.3760
SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.
SprintRay Apex Flex is a photo-polymeric methacrylate/acrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to fabricate partial dentures by 3D printing layer upon layer of the composite material. The product is available in two shades: Light Pink and Standard Pink.
SprintRay Apex Flex resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Apex Flex resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Apex Flex file created in an optical impression system, 3D printer, and curing light equipment.
Apex Flex resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.
The provided document is an FDA 510(k) clearance letter and supporting summary for a dental resin product, SprintRay Apex Flex. This document does not describe an AI/ML-enabled medical device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the substantial equivalence of a new dental material (resin) to existing predicate devices based on physical, chemical, and biocompatibility properties.
Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., test set data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the material properties of the SprintRay Apex Flex device as presented in the document.
Analysis of Acceptance Criteria and Device Performance for SprintRay Apex Flex
The "acceptance criteria" for this device are implicitly derived from the performance of the predicate and reference devices, and conformance to industry consensus standards like ISO 20795-1. The SprintRay Apex Flex is demonstrated to be substantially equivalent to these devices by meeting comparable performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison of the SprintRay Apex Flex (Subject Device) against its primary predicate (Flex-Star V), secondary predicate (TCS® Unbreakable), and a reference device (SprintRay NightGuard Flex). The "acceptance criteria" are not explicitly stated as numerical thresholds but are implied by the measured values of the predicate devices, particularly the Flex-Star V as the primary predicate. The subject device must show comparable or improved performance without raising new safety or effectiveness concerns.
| Performance Metric | Implied Acceptance Criteria (Predicate/Reference Range or Pass) | Reported SprintRay Apex Flex Performance |
|---|---|---|
| Material Type | Thermoplastic nylon resin (predicates), Light-curable polymerizable resin (reference) | Light-curable polymerizable resin |
| Biocompatibility | Tested to ISO-10993-1 and ISO 7405 (for NightGuard Flex) | Tested to ISO-10993-1 and ISO 7405; Considered tissue contacting > 30 days. |
| Flexural Strength | ~26.9 MPa (Flex-Star V), Similar (TCS Unbreakable), 10.4-11.2 MPa (NightGuard Flex) | 26.5 ± 0.8 MPa |
| Flexural Modulus | ~612 MPa (Flex-Star V), 353 ± 4.2 MPa (TCS Unbreakable), 169 ± 1.6 MPa (NightGuard Flex) | 748 ± 21 MPa |
| Water Sorption | Pass (Flex-Star V), 14.8 ± 0.4 µg/mm³ (TCS Unbreakable), 19.5 ± 1.6 µg/mm³ (NightGuard Flex) | 8.9 ± 0.3 µg/mm³ |
| Water Solubility | Pass (Flex-Star V), 2.5 ± 0.7 µg/mm³ (TCS Unbreakable), 1.6 ± 0.7 µg/mm³ (NightGuard Flex) | 3.3 ± 0.2 µg/mm³ |
| Residual Monomer (Methyl Methacrylate) | Not detectable | Not detectable |
| Other Bench Tests (Pass/Fail) | Conformity with ISO 20795-1 (implied pass/acceptable range) for: Total Fracture Work, Maximum Stress Intensity Factor, Tolerance, Depth of Cure, Accuracy Fitting, Shade, Freedom from Porosity, Homogeneity, Viscosity. | "Functioned as intended and the outcomes were as expected" (indicates pass/acceptable). |
Summary of Device Performance: SprintRay Apex Flex demonstrates comparable or in some cases superior physical properties (e.g., flexural modulus, lower water sorption) compared to the predicate and reference devices, while meeting biocompatibility and other standard requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/ML model for diagnostic performance. The "testing" refers to bench testing of material properties.
- Sample Size: The exact number of samples tested for each material property (e.g., flexural strength, sorption) is not provided. The results are reported with mean values and standard deviations, implying multiple samples were tested for each property as per ISO standards.
- Data Provenance: The data is generated from bench testing of the manufactured SprintRay Apex Flex resin. The "country of origin" for this data would be the location where these laboratory tests were conducted, which is not specified in the document but is typically part of the manufacturer's internal testing process. The nature of the data is prospective in the sense that the manufacturer specifically produced and tested samples of the Apex Flex resin for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the document describes a material and its physical properties, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for material properties is established by standardized test methods (e.g., ISO 20795-1) and measurement equipment, not by human experts.
4. Adjudication Method for the Test Set
Not applicable. As the "test set" refers to material samples undergoing physical and chemical tests, there is no need for adjudicating human interpretations.
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 document pertains to a dental material, not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This question refers to AI algorithm performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on standardized laboratory measurements of physical, mechanical, and chemical properties (e.g., flexural strength, water sorption) as defined by ISO consensus standards (specifically ISO 20795-1 and ISO 10993-1/7405 for biocompatibility). There is no "expert consensus" or "pathology" in the context of a diagnostic outcome.
8. The Sample Size for the Training Set
Not applicable. As this is a material, there is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are measured.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this type of device.
Ask a specific question about this device
Page 1 of 19