Who is the manufacturer of RODIN Titan 3D Resin?

Belport Company, Inc., Gingi-Pak filed the 510(k) submission for RODIN Titan 3D Resin (K240688).

What is the FDA product code for RODIN Titan 3D Resin?

EBI. It is classified under 21 CFR 872.3760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for RODIN Titan 3D Resin?

510(k) clearance (submission type: Traditional).

What are the predicate devices for RODIN Titan 3D Resin?

SprintRay OnX Tough (K230445); Pac-Dent Ceramic Nanohybrid Resin (K210412).

Who can help prepare an FDA 510(k) submission like RODIN Titan 3D Resin?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RODIN Titan 3D Resin

K240688 · Belport Company, Inc., Gingi-Pak · EBI · Jun 20, 2024 · Dental

Device Facts

Record ID	K240688
Device Name	RODIN Titan 3D Resin
Applicant	Belport Company, Inc., Gingi-Pak
Product Code	EBI · Dental
Decision Date	Jun 20, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3760
Device Class	Class 2

Intended 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.

Device Story

RODIN Titan 3D Resin is a light-curable dental acrylate resin; used by clinicians in dental offices to fabricate custom dental prosthetics. Input: 3D scanned image of patient teeth (via optical impression system). Process: CAD/CAM software designs appliance; 3D printer creates mold/structure; resin polymerized via UV lamp (380 nm). Output: Permanent dental restorations (crowns, veneers, dentures). Clinician cleans, trims, and verifies fit chairside. Benefits: Custom-fit, durable, and comfortable dental prosthetics compared to traditional methods.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 20795-1 and ISO 4049:2009. Key metrics: Flexural strength (136 MPa), Elastic Modulus (6.235 GPa), Fracture toughness (4.15 MPa m1/2), Water solubility (0.1 µg/mm³), and Water sorption (26 µg/mm³). Biocompatibility testing (ISO 7405) passed for cytotoxicity, sensitization, irritation, and acute systemic toxicity.

Technological Characteristics

Ceramic-hybrid methacrylate polymer resin (UDMA, HEMA, BHT, TPO, YbF3, Fumed Silica). 3D liquid light-cured printing. Curing wavelength 380 nm. Viscosity 1500 cP. Density 1.59 g/cm³. Complies with ISO 20795-1:2013 and ISO 4049:2009. Non-sterile. Standalone material for use with third-party CAD/CAM systems.

Indications for Use

Indicated for patients requiring permanent dental restorations, including anterior and posterior restorations, occlusal surfaces, inlays, onlays, veneers, full crowns, hybrid dentures, implant-supported dentures, and monolithic full/partial removable dentures.

Regulatory Classification

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.

Predicate Devices

SprintRay OnX Tough (K230445)
Pac-Dent Ceramic Nanohybrid Resin (K210412)

Related Devices

K221678 — SprintRay High Impact Denture Base · Sprintray, Inc. · Nov 10, 2022
K222623 — Digital Crown · Sprintray, Inc. · Dec 14, 2022
K213343 — Saremco Print CROWNTEC · Saremco Dental AG · Jan 21, 2022
K233596 — VarseoSmile TriniQ · Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG · Nov 9, 2023
K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin · Aidite (Qinhuangdao) Technology Co., Ltd. · Apr 30, 2025

Submission Summary (Full Text)

{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): | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 - 1. An impression of the patient's mouth is taken. - 2. The impression is scanned and sent to a 3D printer. - 3. The 3D printer creates a mold of the denture. - 4. The mold is filled with liquid resin. - 5. 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…