(99 days)
Not Found
No
The description focuses on the material properties of the resin and its use in a CAD/CAM system for 3D printing, with no mention of AI or ML for image analysis, design, or manufacturing optimization.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a resin material used to fabricate dental prosthetics, which are restorative devices, not therapeutic.
No
This device is a material (resin) used for fabricating dental prosthetics, not for diagnosing medical conditions. It is a restorative material used for treatment rather than diagnosis.
No
The device is a curable dental acrylate resin, which is a physical material used to fabricate dental prosthetics. While it is used in conjunction with software (CAD/CAM system and 3D scanned images), the device itself is a tangible material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of dental prosthetics and restorations to be used in the patient's mouth. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The device is a material (resin) used in a manufacturing process (3D printing) to create a physical appliance. It does not analyze biological samples or provide information about a patient's health status.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is purely a material for creating a physical restoration.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EBI, EBF
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 lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical impression system
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians in dental offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Results:
- Compressive Strength: 368 MPa
- Flexural Strength: 136 MPa
- Elastic Modulus: 6.235 GPa
- Wavelength for Curing: 380 nm
- Filler particle size distribution: 3 µ
- Stress Intensity Factor: 4.15 MPa m^(1/2)
- Density: 1.59 g/cm³
- Viscosity: 1500 cP
- Total Fracture Work: 2442 J/m²
- Hardness: 95 Shore D
- Water Solubility: 0.1 µg/mm³
- Water Sorption: 26 µg/mm³
- Opacity: 70% @ 1mm thickness
- Radiopacity: 200 mm Al
- Layer Thickness: 100μm
- Biocompatibility: Cytotoxicity (Comply), Sensitization (Comply), Irritation (Comply), Acute Systemic Toxicity (Comply)
- Performance Comparison at different build orientations:
- 0°: Flexural Strength (136 MPa), Elastic Modulus (6.235 GPa), Stress Intensity Factor (4.2 MPa m^(1/2)), Total fracture work (2242 J/m²)
- 45°: Flexural Strength (131 MPa), Elastic Modulus (5.937 GPa), Stress Intensity Factor (4.0 MPa m^(1/2)), Total fracture work (2198 J/m²)
- 60°: Flexural Strength (128 MPa), Elastic Modulus (5.792 GPa), Stress Intensity Factor (3.9 MPa m^(1/2)), Total fracture work (2031 J/m²)
- 90°: Flexural Strength (141 MPa), Elastic Modulus (6.004 GPa), Stress Intensity Factor (4.2 MPa m^(1/2)), Total fracture work (2376 J/m²)
- Performance Comparison between different printers (Asiga Max and Pro 4K):
- Asiga Max: Flexural Strength (135 MPa), Elastic Modulus (5.937 GPa), Stress Intensity Factor (4.1 MPa m^(1/2)), Total fracture work (2337 J/m²)
- Pro 4K: Flexural Strength (138 MPa), Elastic Modulus (6.126 GPa), Stress Intensity Factor (4.2 MPa m^(1/2)), Total fracture work (2496 J/m²)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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).
2
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
3
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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4
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
5
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).
6
| Property | Specification | Result | Testing
Protocols |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------|
| Tooth Shades | N/A | BL, B1, A1, A2 | N/A |
| Compressive
Strength (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) for
Curing | N/A | 380 nm | N/A |
| **Depth of Cure
(mm) | N/A | N/A | N/A |
| Filler particle size
distribution (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 Intensity
Factor | 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% @ 1mm
thickness | 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 | Testing
Protocols |
| Biocompatibility | Sensitization | Comply | ISO 7405 |
| Biocompatibility | Irritation | Comply | ISO 7405 |
| Biocompatibility | Acute Systemic
Toxicity | Comply | ISO 7405 |
| Biocompatibility | Genotoxicity | Unknown | ISO 7405 |
| Biocompatibility | Subacute/Subchronic
Systemic Toxicity | Unknown | ISO 7405 |
| | *Post-cured in Otoflash for 5000 flashes | | |
| | **Depth of Cure and Curing Time are dependent on the
additive CAD/CAM printer, set by the manufacturer. | | |
| | ***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. | | |
Table 1. Physical Properties of Subject Device*:
7
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 Device
RODIN Titan 3D
Resin (K240688) | Primary Predicate
Device
SprintRay OnX
Tough (K230445) | Secondary
Predicate
Device
Pac-Dent
Ceramic
Nanohybrid
Resin
(K210412) | Substantial
Equivalence
with
Predicate
Devices |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Manufacturer | Belport
Company, Inc.,
Gingi-Pak | SprintRay Inc. | Pac-Dent, Inc. | |
| Product Code | EBI, EBF | EBI, PZY | EBF | Substantially
equiv. |
| Regulation
Number | 872.3760,
872.3690 | 872.3760,
872.3590 | 872.3690 | Substantially
equiv. |
| Parameter | Subject Device
RODIN Titan 3D
Resin (K240688) | Primary Predicate
Device
SprintRay OnX
Tough (K230445) | Secondary
Predicate
Device
Pac-Dent
Ceramic
Nanohybrid
Resin
(K210412) | Substantial
Equivalence
with
Predicate
Devices |
| Regulatory
Class | Class II | Class II | Class II | Substantially
equiv. |
| Indication 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. | SprintRay OnX
Tough 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. | Pac-Dent
Ceramic
Nanohybrid
Resin 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. | Substantially
equiv. |
| Parameter | Subject Device
RODIN Titan 3D
Resin (K240688) | Primary Predicate
Device
SprintRay OnX
Tough (K230445) | Secondary
Predicate
Device
Pac-Dent
Ceramic
Nanohybrid | Substantial
Equivalence
with
Predicate
Devices |
| | | | Resin
(K210412) | |
| User
Population | Clinicians in
dental offices | Clinicians in dental
offices | Clinicians in
dental offices | Substantially
equiv. |
| Technology | 3D liquid (light-
cured) print resin
for dental
CAD/CAM | 3D liquid (light-
cured) print resin
for dental
CAD/CAM | 3D liquid (light-
cured) print
resin for dental
CAD/CAM | Substantially
equiv. |
| Material | Methacrylate
polymer resin
(dimethacrylate) | Methacrylate
Monomer/oligomers
that polymerized to
Methymethacrylate
Based polymer | Methacrylate
polymer resin
(dimethacrylate) | Substantially
equiv. |
| Material
Shades | BL, B1, A1, A2 | Unknown | Bleach, A1, A2,
A3, B1 | Substantially
equiv. |
| Biocompatible | Yes | Yes | Yes | Substantially
equiv. |
| OTC or Rx | Rx | Rx | Rx | Substantially
equiv. |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Substantially
equiv. |
| Chemical Composition | | | | |
| Chemical
composition | UDMA
HEMA
BHT
TPO
TF 3.0
YbF3
Fumed Silica | Methacrylate
polymer resin with
photo initiator,
inhibitor and
pigments | UDMA
HEMA
BHT
TPO
TF 3.0
YbF3
Fumed Silica | Substantially
equiv. |
| Non-Clinical Performance Test Data | | | | |
| Performance
Testing | ISO 20795-1
ISO 4049:2009 | ISO 20795-1 | ISO 4049:2009 | Substantially
equiv. |
| Compressive
Strength
(MPa) | 368 MPa | Unknown | 378 MPa | Substantially
equiv. |
| Flexural
Strength
(MPa) | 136 MPa | 126 MPa | 112 MPa | Substantially
equiv. |
| Elastic
Modulus
(GPa) | 6.235 GPa | 4.281 GPa | 10.380 GPa | Substantially
equiv. |
| Parameter | Subject Device
RODIN Titan 3D
Resin (K240688) | Primary Predicate
Device
SprintRay OnX
Tough (K230445) | Secondary
Predicate
Device
Pac-Dent
Ceramic
Nanohybrid
Resin
(K210412) | Substantial
Equivalence
with
Predicate
Devices |
| Wavelength
(nm) for
Curing | 380 nm | 380 nm | 380 nm | Substantially
equiv. |
| Depth of Cure
(mm) | N/A | N/A | N/A | |
| Filler particle
size
distribution (
µ) | 3 µ | N/A | 2 µ | Substantially
equiv. |
| Curing Time
(sec) | N/A | N/A | N/A | |
| Light intensity
for curing
(mW/cm²)* | 8.0 +/-0.5
mW/cm2 | Unknown | 8.0 +/-0.5
mW/cm2 | Substantially
equiv. |
| Stress
Intensity
Factor /
Fracture
Toughness
(MPa • m1/2) | 4.15 MPa • m1/2 | 3.38 MPa • m1/2 | 3.4 MPa • m1/2 | Substantially
equiv. |
| Water
Sorption
(µg/mm³) | 26 µg/mm³ | 30 µg/mm³ | 15.8 µg/mm³ | Substantially
equiv. |
| Water
Solubility
(µg/mm³) | 0.1 µg/mm³ | 3.5 µg/mm³ | 0.4 µg/mm³ | Substantially
equiv. |
| Density | 1.59 g/cm³ | Unknown | 1.78 g/cm³ | Substantially
equiv. |
| Viscosity | 1500 cP | Unknown | 2000 cP | Substantially
equiv. |
| Total Fracture
Work | 2442 J/m² | 1033 J/m² | 964 J/m² | Substantially
equiv. |
| Hardness | 95 Shore D | Unknown | 99 Shore D | Substantially
equiv. |
| Opacity | 70% @ 1mm
thickness | Unknown | 68% @ 1mm
thickness | Substantially
equiv. |
| Radiopacity
(mm of Al) | 200 mm | Unknown | 200 mm | Substantially
equiv. |
| Parameter | Subject Device
RODIN Titan 3D
Resin (K240688) | Primary Predicate
Device
SprintRay OnX
Tough (K230445) | Secondary
Predicate
Device
Pac-Dent
Ceramic
Nanohybrid
Resin
(K210412) | Substantial
Equivalence
with
Predicate
Devices |
| Layer
Thickness | 100 µm | 100 μm | 100 μm | Substantially
equiv. |
| Monomer
Methyl
Methacrylate
(≤2.2%) | Pass | Pass | Pass | Substantially
equiv. |
8
9
10
11
- 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.
| Biocompatibility
Parameter | Subject
Device | Primary
Predicate
Device | Secondary
Predicate
Device | Substantial
Equivalence
with Predicate
Device |
|--------------------------------------------|-------------------|--------------------------------|----------------------------------|--------------------------------------------------------|
| Cytotoxicity (ISO
7405) | Pass | Pass | Pass | Substantially
equiv. |
| Sensitization (ISO
7405) | Pass | Pass | Pass | Substantially
equiv. |
| Irritation (ISO 7405) | Pass | Pass | Pass | Substantially
equiv. |
| Acute Systemic
Toxicity (ISO 7405) | Pass | Pass | Pass | Substantially
equiv. |
| Genotoxicity (ISO
7405) | Unknown | Pass | Unknown | |
| Subacute/Subchronic
Systemic (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 Intensity | |||||
| Factor (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 Intensity | |||||
| Factor (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.
14
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.
15
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.