(99 days)
Rodin Titan 3D Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, veneers and full crown restorations.
RODIN Titan 3D Resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need. Fabrication of dental prosthetics with RODIN Titan 3D Resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment. The material is an alternative to traditional dental prostheses material Rodin Titan 3D Resin is intended exclusively for professional dental work. RODIN Titan 3D 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 are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
The provided text describes a medical device, RODIN Titan 3D Resin, and its acceptance criteria, along with performance data to demonstrate substantial equivalence to predicate devices. The study conducted is primarily a set of performance tests against established standards and comparisons to existing products, rather than a clinical trial with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with international standards (ISO, ASTM) and performance comparable to predicate devices. The "Specification" column in Table 1 represents the acceptance criteria for most physical properties, usually a minimum or maximum value. For some parameters, "N/A" is listed, indicating that there is no specific quantitative acceptance criterion listed in the table, but the result is provided.
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Result) | Underlying Standard/Test Protocol |
|---|---|---|---|
| Physical/Mechanical Properties | |||
| Compressive Strength (MPa) | N/A (Note: Predicate is 378 MPa) | 368 MPa | ASTM D695-15 |
| Flexural Strength (MPa) | ≥65 MPa | 136 MPa | ISO 20795-1: 2013 |
| Elastic Modulus (GPa) | ≥2.0 GPa | 6.235 GPa | ISO 20795-1: 2013 |
| Stress Intensity Factor (MPa m1/2) | Kmax ≥ 1.9 MPa m1/2 | 4.15 MPa m1/2 | ISO 20795-1: 2013 |
| Total Fracture Work (J/m²) | ≥900 J/m² | 2442 J/m² | ISO 20795-1: 2013 |
| Water Solubility (µg/mm³) | ≤1.6 µg/mm³ | 0.1 µg/mm³ | ISO 20795-1: 2013 |
| Water Sorption (µg/mm³) | ≤32 µg/mm³ | 26 µg/mm³ | ISO 20795-1: 2013 |
| Radiopacity | > 100 mm Al | 200 mm Al | ISO 4049: 2009 |
| Monomer Methyl Methacrylate | ≤2.2% | Pass | |
| Hardness | N/A (Note: Predicate is 99 Shore D) | 95 Shore D | ASTM D2240 |
| Biocompatibility | |||
| Cytotoxicity | Comply | Comply (Pass) | ISO 7405 |
| Sensitization | Comply | Comply (Pass) | ISO 7405 |
| Irritation | Comply | Comply (Pass) | ISO 7405 |
| Acute Systemic Toxicity | Comply | Comply (Pass) | ISO 7405 |
| Genotoxicity | Comply (Note: Predicate passed) | Unknown | ISO 7405 |
| Subacute/Subchronic Systemic Tox | Comply (Note: Predicate unknown) | Unknown | ISO 7405 |
Note: For properties listed as N/A under "Specification", their acceptance is often implied by demonstrating comparable performance to predicate devices or simply reporting the value without a specific threshold stated within the document. The comparability to predicate devices is shown in Table 2.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size (e.g., number of specimens tested for flexural strength). It refers to the tests being conducted according to specific ISO and ASTM standards, which would define the required sample sizes for each test method.
- Data Provenance: The data appears to be from laboratory testing performed by the manufacturer, or a contracted lab, to characterize the material properties. There is no information provided regarding the country of origin of the data or whether it is retrospective or prospective, but it is characteristic of premarket submission data based on physical and chemical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve expert readers establishing ground truth in the way a diagnostic imaging AI would. The "ground truth" for the performance tests outlined here is defined by:
- Established physical and chemical test methods: The performance data (e.g., flexural strength, water sorption) are objective measurements derived from standardized laboratory tests (ISO, ASTM protocols).
- Predicate device data: The "ground truth" for substantial equivalence comparison is the performance of legally marketed predicate devices, which have already been deemed safe and effective.
Therefore, there were no human experts (e.g., radiologists) establishing ground truth for the test set in this context. The "experts" would be the scientists and engineers who conducted the material characterization tests and those who established the ISO/ASTM standards.
4. Adjudication Method for the Test Set
Not applicable for this type of material characterization study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly for diagnostic accuracy, where there is subjective interpretation of findings (e.g., by multiple radiologists) requiring a consensus mechanism.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers' Improvement with AI vs. without AI Assistance
Not applicable. This device is a dental resin material, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assisted human reader improvement analysis was performed or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Not applicable. This is a physical material, not an algorithm. The performance data presented are "standalone" in the sense that they are intrinsic properties of the material itself, measured in laboratory settings.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for this device's performance is based on:
- Standardized Physical and Chemical Characterization: Data derived from established and validated laboratory test methods (ISO, ASTM standards). This is the primary ground truth for material properties.
- Predicate Device Performance: Performance data from already cleared predicate devices serve as a comparative ground truth to establish substantial equivalence.
- Biocompatibility Standards: Compliance with ISO 10993 provides the ground truth for biological safety.
8. The Sample Size for the Training Set
Not applicable. This device is a material, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a material or a traditional AI model discussed.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2024
Belport Company, Inc., Gingi-Pak Daniel Gallegos Regulatory Affairs Specialist 670 Endeavor Circle Brea, California 92821
Re: K240688
Trade/Device Name: RODIN Titan 3D Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, EBF Dated: March 12, 2024 Received: March 13, 2024
Dear Daniel Gallegos:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240688
Device Name RODIN Titan 3D Resin
Indications for Use (Describe)
Rodin Titan 3D Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implantsupported denture prosthetics, monolithic full and partial removable denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, veneers and full crown restorations.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Submission RODIN Titan 3D Resin 510(k) Summary K240688
Submitter:
Belport Company, Inc., Gingi-Pak 670 Endeavor Circle Brea, CA 92821
Phone: (714) 990-5488
Contact Person: Daniel Gallegos
Date Prepared: April 25, 2024
| Name of Device: | RODIN Titan 3D Resin |
|---|---|
| Common or Usual Name: | Tooth shade resin material |
| Regulation Number and Name: | 21 CFR 872.3760, 21 CFR 872.3690 |
| Product Code | EBI, EBF |
| Device Class | Class II |
| Primary Predicate | K230445, SprintRay OnX Tough |
| Secondary Predicate | K210412, Pac-Dent Ceramic Nanohybrid Resin |
Device Description:
RODIN Titan 3D Resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need. Fabrication of dental prosthetics with RODIN Titan 3D Resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment. The material is an alternative to traditional dental prostheses material Rodin Titan 3D Resin is intended exclusively for professional dental work. RODIN Titan 3D 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 are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV
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lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
Intended Use / Indications for Use
RODIN Titan 3D Resin is a tooth shade ceramic hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior and posterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations,
The intended use of fabrication of monolithic full and partial removable dentures is the same as the primary predicate device (K230445) (product code EBI) and the indication as a permanent restorative is the same as the secondary predicate device (K210412) (product code EBF). The intended use, technological characteristics, and critical specifications, of RODIN Titan 3D Resin are similar to the predicate devices.
Summary of Technological Characteristics
RODIN Titan 3D Resin and the primary (K230445) and secondary (K210412) predicate devices are all 3D printed denture devices. The liquid resin is polymerized in the 3D printer, which creates the final denture device. Here is a more detailed explanation of the process:
RODIN Titan 3D Resin, Primary Predicate Device, and Secondary Predicate Device
-
- An impression of the patient's mouth is taken.
-
- The impression is scanned and sent to a 3D printer.
-
- The 3D printer creates a mold of the denture.
-
- The mold is filled with liquid resin.
-
- The resin is polymerized, which creates the final denture device.
RODIN Titan 3D Resin, the primary predicate device, and the secondary predicate device are created using 3D printing technology. This technology allows for the creation of custom-fit dentures that are more comfortable and durable than traditional dentures. The principles of operation are essentially similar; therefore, the RODIN Titan 3D Resin is substantially equivalent to its predicate devices.
Performance Requirements:
RODIN Titan 3D Resin conforms to the requirements of ISO 4049:2009 (Dentistry -Polymer-based restorative materials), ISO 20795-1: 2013 (Dentistry - Base Polymers) and EN ISO10993-1/ISO 7405 (Biological evaluation of medical devices).
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| Property | Specification | Result | TestingProtocols |
|---|---|---|---|
| Tooth Shades | N/A | BL, B1, A1, A2 | N/A |
| CompressiveStrength (MPa) | N/A | 368 MPa | ASTM D695-15 |
| Flexural Strength(MPa) | ≥65 MPa | 136 MPa | ISO 20795-1:2013 |
| Elastic Modulus(GPa) | ≥2.0GPa | 6.235 GPa | ISO 20795-1:2013 |
| Wavelength (nm) forCuring | N/A | 380 nm | N/A |
| **Depth of Cure(mm) | N/A | N/A | N/A |
| Filler particle sizedistribution (μ) | N/A | 3 μ | N/A |
| **Curing Time (sec) | N/A | N/A | N/A |
| ***Release Profile (μ g/mm³) | N/A | N/A | N/A |
| ****Working Time(sec) | N/A | N/A | N/A |
| ****Setting Time(min) | N/A | N/A | N/A |
| Stress IntensityFactor | Kmax ≥ 1.9 MPa m1/2 | 4.15 MPa m1/2 | ISO 20795-1:2013 |
| Density | N/A | 1.59 g/cm³ | N/A |
| Viscosity | N/A | 1500 cP | N/A |
| Total Fracture Work | ≥900 J/m² | 2442 (J/m²) | ISO 20795-1:2013 |
| Hardness | N/A | 95 Shore D | ASTM D2240 |
| Water Solubility | ≤1.6 µg/mm³ | 0.1 µg/mm³ | ISO 20795-1:2013 |
| Water Sorption | ≤32 µg/mm³ | 26 µg/mm³ | ISO 20795-1:2013 |
| Opacity | N/A | 70% @ 1mmthickness | N/A |
| Radiopacity | > 100 mm Al | 200 mm Al | ISO 4049: 2009 |
| Layer Thickness | N/A | 100μm | N/A |
| Biocompatibility | Cytotoxicity | Comply | ISO 7405 |
| Property | Specification | Result | TestingProtocols |
| Biocompatibility | Sensitization | Comply | ISO 7405 |
| Biocompatibility | Irritation | Comply | ISO 7405 |
| Biocompatibility | Acute SystemicToxicity | Comply | ISO 7405 |
| Biocompatibility | Genotoxicity | Unknown | ISO 7405 |
| Biocompatibility | Subacute/SubchronicSystemic Toxicity | Unknown | ISO 7405 |
| *Post-cured in Otoflash for 5000 flashes | |||
| **Depth of Cure and Curing Time are dependent on theadditive CAD/CAM printer, set by the manufacturer. | |||
| ***The resin does not contain any releasable agent. | |||
| ****Working time and setting time are not applicable becausethe resin is instantly cured and solidified by a light source, thephoto initiation reaction occurs instantly without additionalworking time. |
Table 1. Physical Properties of Subject Device*:
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Equivalence to Marketed Devices
The following table compares technological and other characteristics of the subject, primary predicate, and secondary predicate device.
| Table 2. Comparison of Technological Characteristics with Predicates | ||
|---|---|---|
| Parameter | Subject DeviceRODIN Titan 3DResin (K240688) | Primary PredicateDeviceSprintRay OnXTough (K230445) | SecondaryPredicateDevicePac-DentCeramicNanohybridResin(K210412) | SubstantialEquivalencewithPredicateDevices |
|---|---|---|---|---|
| Manufacturer | BelportCompany, Inc.,Gingi-Pak | SprintRay Inc. | Pac-Dent, Inc. | |
| Product Code | EBI, EBF | EBI, PZY | EBF | Substantiallyequiv. |
| RegulationNumber | 872.3760,872.3690 | 872.3760,872.3590 | 872.3690 | Substantiallyequiv. |
| Parameter | Subject DeviceRODIN Titan 3DResin (K240688) | Primary PredicateDeviceSprintRay OnXTough (K230445) | SecondaryPredicateDevicePac-DentCeramicNanohybridResin(K210412) | SubstantialEquivalencewithPredicateDevices |
| RegulatoryClass | Class II | Class II | Class II | Substantiallyequiv. |
| Indication foruse | RODIN Titan 3DResin is a toothshade ceramichybrid resin usedfor thefabrication ofhybrid dentureprosthetics,implant-supporteddentureprosthetics,monolithic fulland partialremovabledentures, andpreformeddenture teeth tobe used in adenture. It isindicated as apermanentrestorative forboth anterior andposteriorrestorations,includingocclusalsurfaces. It isused forfabricatingpermanentrestorations suchas inlays, onlays,veneers and fullcrownrestorations. | SprintRay OnXTough is a toothshade ceramichybrid resin usedfor the fabrication ofhybrid dentureprosthetics,implant-supporteddenture prosthetics,monolithic full andpartial removabledentures, andpreformed dentureteeth to be used ina denture. | Pac-DentCeramicNanohybridResin isindicated as apermanentrestorative forboth anteriorand posteriorrestorations,includingocclusalsurfaces. It isused forfabricatingpermanentrestorationssuch as inlays,onlays, veneersand full crownrestorations. | Substantiallyequiv. |
| Parameter | Subject DeviceRODIN Titan 3DResin (K240688) | Primary PredicateDeviceSprintRay OnXTough (K230445) | SecondaryPredicateDevicePac-DentCeramicNanohybrid | SubstantialEquivalencewithPredicateDevices |
| Resin(K210412) | ||||
| UserPopulation | Clinicians indental offices | Clinicians in dentaloffices | Clinicians indental offices | Substantiallyequiv. |
| Technology | 3D liquid (light-cured) print resinfor dentalCAD/CAM | 3D liquid (light-cured) print resinfor dentalCAD/CAM | 3D liquid (light-cured) printresin for dentalCAD/CAM | Substantiallyequiv. |
| Material | Methacrylatepolymer resin(dimethacrylate) | MethacrylateMonomer/oligomersthat polymerized toMethymethacrylateBased polymer | Methacrylatepolymer resin(dimethacrylate) | Substantiallyequiv. |
| MaterialShades | BL, B1, A1, A2 | Unknown | Bleach, A1, A2,A3, B1 | Substantiallyequiv. |
| Biocompatible | Yes | Yes | Yes | Substantiallyequiv. |
| OTC or Rx | Rx | Rx | Rx | Substantiallyequiv. |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Substantiallyequiv. |
| Chemical Composition | ||||
| Chemicalcomposition | UDMAHEMABHTTPOTF 3.0YbF3Fumed Silica | Methacrylatepolymer resin withphoto initiator,inhibitor andpigments | UDMAHEMABHTTPOTF 3.0YbF3Fumed Silica | Substantiallyequiv. |
| Non-Clinical Performance Test Data | ||||
| PerformanceTesting | ISO 20795-1ISO 4049:2009 | ISO 20795-1 | ISO 4049:2009 | Substantiallyequiv. |
| CompressiveStrength(MPa) | 368 MPa | Unknown | 378 MPa | Substantiallyequiv. |
| FlexuralStrength(MPa) | 136 MPa | 126 MPa | 112 MPa | Substantiallyequiv. |
| ElasticModulus(GPa) | 6.235 GPa | 4.281 GPa | 10.380 GPa | Substantiallyequiv. |
| Parameter | Subject DeviceRODIN Titan 3DResin (K240688) | Primary PredicateDeviceSprintRay OnXTough (K230445) | SecondaryPredicateDevicePac-DentCeramicNanohybridResin(K210412) | SubstantialEquivalencewithPredicateDevices |
| Wavelength(nm) forCuring | 380 nm | 380 nm | 380 nm | Substantiallyequiv. |
| Depth of Cure(mm) | N/A | N/A | N/A | |
| Filler particlesizedistribution (µ) | 3 µ | N/A | 2 µ | Substantiallyequiv. |
| Curing Time(sec) | N/A | N/A | N/A | |
| Light intensityfor curing(mW/cm²)* | 8.0 +/-0.5mW/cm2 | Unknown | 8.0 +/-0.5mW/cm2 | Substantiallyequiv. |
| StressIntensityFactor /FractureToughness(MPa • m1/2) | 4.15 MPa • m1/2 | 3.38 MPa • m1/2 | 3.4 MPa • m1/2 | Substantiallyequiv. |
| WaterSorption(µg/mm³) | 26 µg/mm³ | 30 µg/mm³ | 15.8 µg/mm³ | Substantiallyequiv. |
| WaterSolubility(µg/mm³) | 0.1 µg/mm³ | 3.5 µg/mm³ | 0.4 µg/mm³ | Substantiallyequiv. |
| Density | 1.59 g/cm³ | Unknown | 1.78 g/cm³ | Substantiallyequiv. |
| Viscosity | 1500 cP | Unknown | 2000 cP | Substantiallyequiv. |
| Total FractureWork | 2442 J/m² | 1033 J/m² | 964 J/m² | Substantiallyequiv. |
| Hardness | 95 Shore D | Unknown | 99 Shore D | Substantiallyequiv. |
| Opacity | 70% @ 1mmthickness | Unknown | 68% @ 1mmthickness | Substantiallyequiv. |
| Radiopacity(mm of Al) | 200 mm | Unknown | 200 mm | Substantiallyequiv. |
| Parameter | Subject DeviceRODIN Titan 3DResin (K240688) | Primary PredicateDeviceSprintRay OnXTough (K230445) | SecondaryPredicateDevicePac-DentCeramicNanohybridResin(K210412) | SubstantialEquivalencewithPredicateDevices |
| LayerThickness | 100 µm | 100 μm | 100 μm | Substantiallyequiv. |
| MonomerMethylMethacrylate(≤2.2%) | Pass | Pass | Pass | Substantiallyequiv. |
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- Intensity, Wavelength and Depth of Cure for Curing are dependent on the additive CAD/CAM printer, set by the manufacturer. The photo initiator, TPO exhibits an absorption spectrum at 380nm.
**The resin does not contain any releasable agent.
***Working time and setting time are not applicable because the resin is instantly cured and solidified by a light source, the photo initiation reaction occurs instantly without additional working time.
| BiocompatibilityParameter | SubjectDevice | PrimaryPredicateDevice | SecondaryPredicateDevice | SubstantialEquivalencewith PredicateDevice |
|---|---|---|---|---|
| Cytotoxicity (ISO7405) | Pass | Pass | Pass | Substantiallyequiv. |
| Sensitization (ISO7405) | Pass | Pass | Pass | Substantiallyequiv. |
| Irritation (ISO 7405) | Pass | Pass | Pass | Substantiallyequiv. |
| Acute SystemicToxicity (ISO 7405) | Pass | Pass | Pass | Substantiallyequiv. |
| Genotoxicity (ISO7405) | Unknown | Pass | Unknown | |
| Subacute/SubchronicSystemic (ISO 7405) | Unknown | Unknown | Unknown |
Table 3. Comparison of Biocompatibility with Predicates
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| RODIN Titan(K240688) | Specification | 0° | 45° | 60° | 90° |
|---|---|---|---|---|---|
| Visual Appearance | Homogenous | Pass | Pass | Pass | Pass |
| Flexural Strength(MPa) | > 50 | 136 | 131 | 128 | 141 |
| Elastic Modulus(GPa) | N/A | 6.235 | 5.937 | 5.792 | 6.004 |
| Stress IntensityFactor (MPa*m1/2) | ≥1.9 | 4.2 | 4.0 | 3.9 | 4.2 |
| Total fracture work(J/m²) | ≥900 | 2242 | 2198 | 2031 | 2376 |
Table 4. Subject Device Performance Comparison at different build orientation
Table 5. Predicate Device Performance Comparison at different build orientation
| OnX Tough(K230445) | Specification | 0° | 45° | 60° | 90° |
|---|---|---|---|---|---|
| Visual Appearance | Homogenous | Pass | Pass | Pass | Pass |
| Flexural Strength(MPa) | > 50 | 71 | 75 | 69 | 74 |
| Elastic Modulus(GPa) | N/A | 4.271 | 4.407 | 4.097 | 4.512 |
| Stress IntensityFactor (MPa*m1/2) | ≥1.9 | 3.2 | 3.4 | 3.0 | 3.3 |
| Total fracture work(J/m2) | ≥900 | 945 | 1002 | 892 | 990 |
Table 6. Subject Device Performance Comparison between different printers
| RODIN Titan (K240688) | Specification | Asiga Max | Pro 4K |
|---|---|---|---|
| Visual Appearance | Homogenous | Pass | Pass |
| Flexural Strength (MPa) | > 50 | 135 | 138 |
| Elastic Modulus (GPa) | N/A | 5.937 | 6.126 |
| Stress Intensity Factor(MPa*m1/2) | ≥1.9 | 4.1 | 4.2 |
| Total fracture work (J/m2) | ≥900 | 2337 | 2496 |
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Image /page/13/Figure/0 description: The image shows a 3D rendering of a 3D printer's build plate with several orange rectangular objects arranged on it. The objects are aligned in rows and columns, suggesting a printing arrangement. The build plate is a grid pattern, and the image includes text labels indicating coordinates or dimensions, such as 'Y: 68.077' and 'X: 121.025'. The text 'MAX UVS65 (version 2013-09-01) 121.03 x 66.08 x 76.00 mm' is also visible, providing information about the software or dimensions of the objects.
Figure 1. RODIN Titan worst-case build orientation testing at ninety degrees.
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Image /page/14/Figure/0 description: The image shows a 3D rendering of two sets of rectangular prisms on a gridded surface. The larger set consists of approximately 10 prisms, while the smaller set has around 20. The text "Origin" and "X: 216.031" are visible in the image, likely indicating coordinate points within the 3D space.
Figure 2. RODIN Titan worst-case build orientation testing at zero degrees.
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Image /page/15/Figure/0 description: The image shows a 3D rendering of a 3D printer's build plate with several orange rectangular objects being printed. The objects are supported by purple support structures. The text in the image indicates the printer model is a MAX UV385 (version 2023-09-01) and the x coordinate is 121.025.
Figure 3. RODIN Titan worst-case build orientation testing at forty-five degrees.
Conclusions
The RODIN Titan 3D Resin is as safe and effective as its predicate devices. The RODIN Titan 3D Resin has the same intended use and indication, and similar technological characteristics as its predicate devices. The minor technological differences between the RODIN Titan 3D Resin and its predicate devices raise no new issues of safety and effectiveness. Performance data demonstrate that the RODIN Titan 3D Resin is as safe and effective as the predicate devices. Thus, the RODIN Titan 3D Resin is substantially equivalent.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.