(1 days)
FREEPRINT® crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces.
The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.
Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary or permanent dental restorations such as crowns and bridges, inlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary dental restorations.
Restorations fabricated using the Subject device are one-time use, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments.
Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.
The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
The provided document describes the FDA 510(k) premarket notification for the FREEPRINT® crown device, which is a light-cured methacrylate-based resin for 3D printing dental restorations. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FREEPRINT® crown are primarily based on meeting the requirements of recognized international standards for dental materials. The reported device performance is compared against these standards and against predicate/reference devices.
| Acceptance Criteria (Standard / Parameter) | Performance Criteria | Reported Device Performance (FREEPRINT® crown) |
|---|---|---|
| ISO 4049:2019 (Dentistry — Polymer-based restorative materials) | Meets requirements | Device meets the property requirements |
| ISO 10477:2018 (Dentistry – Polymer-based crown and veneering materials) | Meets requirements | Device meets the property requirements |
| Depth of Cure (ISO 4049 & 10477) | Hardness of bottom surface ≥70% top surface | Meets requirements of ISO 4049 and ISO 10477 |
| Surface Finish (ISO 4049 & 10477) | Glossy surface after polishing | Meets requirements of ISO 4049 and ISO 10477 |
| Flexural Strength (ISO 4049 & 10477) | ≥ 100 MPa | ≥ 100 MPa |
| Water Sorption (ISO 4049 & 10477) | ≤ 40 µg/mm³ | ≤ 40 µg/mm³ |
| Water Solubility (ISO 4049 & 10477) | ≤ 7.5 µg/mm³ | ≤ 7.5 µg/mm³ |
| Biocompatibility (ISO 7405, ISO 10993 series) | Meets requirements | Meets requirements as per testing to listed ISO standards |
| MRI Safety | Supports MR Safety labeling | An MRI safety assessment was performed to support MR Safety labeling |
Note: For several parameters (Depth of Cure, Surface Finish, Flexural Strength, Water Sorption, Water Solubility), the document explicitly states that the FREEPRINT® crown meets the requirements of the listed ISO standards, but for some, it also provides specific values for the subject device or for the predicate/reference devices. The table above uses the explicitly stated acceptance thresholds where given.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of specimens) used for each non-clinical test (e.g., flexural strength, water sorption, biocompatibility). It states that "Physical property testing was performed on the Subject device to ISO 4049:2019...and ISO 10477:2018." These standards typically define the number of test specimens required for various mechanical and physical property evaluations.
Data Provenance: The data is primarily from non-clinical laboratory testing ("Non-clinical Performance Testing") conducted to support the substantial equivalence claim. The country of origin for the testing itself is not explicitly stated, but the manufacturer is DETAX GmbH, located in Germany, suggesting the testing might have been conducted there or in labs compliant with international standards. The document also mentions comparative material property testing performed with a "Reference device," implying some form of internal or contracted testing. This is retrospective data, as it was collected before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is not an AI/Software as a Medical Device (SaMD) that diagnoses or interprets medical images, so the concept of "ground truth" established by experts in a clinical context (e.g., radiologists) is not applicable here. The "ground truth" for this device, which is a dental material, is defined by the objective, quantifiable physical, chemical, and biological properties measured against established international standards (ISO). The "experts" involved would be the material scientists, engineers, and chemists who conducted and interpreted the laboratory tests according to the specified standard operating procedures and test methods. Their specific number and qualifications are not detailed in this FDA letter, but it's presumed they possess the necessary expertise to perform these standardized tests.
4. Adjudication Method for the Test Set
Not applicable. Since the "ground truth" is defined by objective physical and chemical measurements against ISO standards for material performance, there is no need for an adjudication method as would be used in expert consensus for clinical image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document explicitly states: "The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical or animal testing data is included in this submission." Therefore, an MRMC study, which is a type of clinical study, was not performed. The device is a dental material, not an AI or imaging device where MRMC studies are typically relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm. Its performance is measured directly by its physical, chemical, and biocompatibility properties when fabricated into a dental restoration.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements of material properties according to established international consensus standards (ISO standards) for dental restorative materials. These include:
- Physical properties (e.g., flexural strength, water sorption, water solubility, depth of cure, surface finish).
- Chemical characterization of its composition.
- Biocompatibility testing results (cytotoxicity, sensitization, irritation, etc.).
8. The Sample Size for the Training Set
Not applicable. This is a material, not a machine learning algorithm, so there is no concept of a "training set" for an AI model. For material development, batches are produced and tested, but this is part of quality control and R&D, not an "AI training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of an AI model. For the material's development and evaluation, the "ground truth" or acceptable parameters are set by the performance requirements outlined in the relevant ISO standards (e.g., ISO 4049, ISO 10477, ISO 10993 series). These standards represent an international consensus on the minimum performance and safety requirements for such dental materials.
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September 23, 2022
DETAX GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K222877
Trade/Device Name: FREEPRINT crown Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF, EBG Dated: August 5, 2022 Received: September 22, 2022
Dear Prithul Bom:
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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name FREEPRINT® crown
Indications for Use (Describe)
FREEPRINT® crown is indicated as an indirect restorative for both anterior restorations. including occlusal surfaces.
The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.
Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary DETAX GmbH FREEPRINT® crown 9/13/2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name: DETAX GmbHCarl-Zeiss-Strasse 4D-76275 Ettingen, GermanyTelephone: +49 7243/510-138 | Consultant: Aclivi, LLC3250 Brackley DriveAnn Arbor, Michigan 48105Telephone: +1 810 360-9773 |
|---|---|
| Official Contact: Markus Stratmann - Divisional Director 3DEmail: Markus.Stratmann@detax.de | Chris Brown - Manageracliviconsulting@gmail.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | FREEPRINT® crown |
|---|---|
| Regulation Name: | Material, Tooth Shade, Resin |
| Regulation Number: | 21 CFR 872.3690 |
| Device Class: | Class II |
| Product Code: | EBF |
| Review Panel: | Dental |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The Subject device in this submission is substantially equivalent in indications, use and design principles to the following Predicate device.
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K202846 | TERA HARZ | Graphy Inc |
| 510(k) | Reference Device Name | Company Name |
| BEGO Bremer Goldschlägerei Wilh. |
Herbst GmbH & Co. KG
INDICATIONS FOR USE
FREEPRINT® crown is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces.
VarseoSmile Crown Plus
The FREEPRINT® crown material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations.
Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
DEVICE DESCRIPTION
The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of temporary or permanent dental restorations such as crowns and bridges, inlays, veneers and full crown restorations
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including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary dental restorations.
Restorations fabricated using the Subject device are one-time use, prescription-only devices. The Subject device is a viscous solution consisting of methacrylate-based resins, photo initiators and pigments.
Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.
The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
EQUIVALENCE TO MARKETED DEVICE
The Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. The comparison tables below compare the Indications for Use and Technological Characteristics of the Subject, Predicate and Reference devices.
| Device | Indications for Use Statement |
|---|---|
| Subject DeviceFREEPRINT® crownDETAX GmbH | FREEPRINT® crown is indicated as an indirect restorative for both anterior and posteriorrestorations, including occlusal surfaces.The FREEPRINT® crown material is used for fabricating temporary or permanent restorations suchas crowns and bridges, inlays, onlays, veneers and full crown restorations.Fabrication of FREEPRINT® crown requires a computer-aided and manufacturing (CAD/CAM)system that includes the following: scanner, design software, additive printer, and post-cure unit. |
| Predicate DeviceTERA HARZ (K202846)Graphy Inc | TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations,including occlusal surfaces.The TERA HARZ material is used for fabricating temporary or permanent restorations such ascrowns and bridges, inlays, onlays, veneers and full crown restorations.Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system thatincludes the following: scanner, design software, additive printer, and post-cure unit. |
| Reference DeviceVarseoSmile Crown Plus (K201668)BEGO Bremer Goldschlägerei Wilh. HerbstGmbH & Co. KG | VarseoSmile Crown plus is indicated as an indirect restorative for both anterior and posteriorrestorations, including occlusal surfaces. The VarseoSmile Crown plus material is used for fabricatingpermanent restorations such as inlays, onlays, veneers and full crown restorations. |
Indications For Use
The Subject and Predicate Indications for Use Statement (IFUS) are highly similar, differing only by the device name. The Reference device IFUS is similar in wording, with a similar usage of the material, but focusing only on permanent restorations. Slight differences in the wording of the device name within Indications for Use Statements does not change the intended use of the Subject and Predicate devices to fabricate temporary or permanent dental restorations.
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Technological Characteristics
| Subject Device | Predicate Device | Reference Device | Comparison withPredicate Device | |
|---|---|---|---|---|
| FREEPRINT® crownDETAX GmbH | TERA HARZ ( K202846)Graphy Inc | VarseoSmile Crown Plus (K201668)BEGO Bremer Goldschlägerei Wilh.Herbst GmbH & Co. KG | ||
| Parameter | ||||
| Reason forPredicate/Reference | n/a | IFUS, Technological Characteristics | Comparative BenchPerformance Testing | Same |
| Product Code | EBF | EBF, EBG | EBF | Same |
| Regulation Number | 872.3690 | 872.3690 | 872.3690 | Same |
| Regulatory Class | Class II | Class II | Class II | Same |
| FREEPRINT® crown is indicated as anindirect restorative for both anterior andposterior restorations, including occlusalsurfaces. | TERA HARZ is indicated as anindirect restorative for both anteriorand posterior restorations, includingocclusal surfaces. | VarseoSmile Crown plus isindicated as an indirectrestorative for both anterior andposterior restorations, includingocclusal surfaces. The | Highly Similar | |
| The FREEPRINT® crown material is usedfor fabricating temporary or permanentrestorations such as crowns and bridges,inlays, onlays, veneers and full crownrestorations. | The TERA HARZ material is used forfabricating temporary or permanentrestorations such as crowns andbridges, inlays, onlays, veneers andfull crown restorations. | VarseoSmile Crown plus materialis used for fabricatingpermanent restorations such asinlays, onlays, veneers and fullcrown restorations. | ||
| Intended Use | Fabrication of FREEPRINT® crownrequires a computer-aided andmanufacturing (CAD/CAM) system thatincludes the following: scanner, designsoftware, additive printer, and post-cureunit. | Fabrication of TERA HARZ requires acomputer-aided and manufacturing(CAD/CAM) system that includes thefollowing: scanner, design software,additive printer, and post-cure unit. | ||
| Technology | 3D liquid (light-cured) print resin fordental CAD/CAM | 3D liquid (light-cured) print resin fordental CAD/CAM | 3D liquid (light-cured) print resinfor dental CAD/CAM | Same |
| Material | Methacrylate polymer resin(includes dimethacrylate) | Methacrylate polymer resin(dimethacrylate) | Methacrylate polymer resin(dimethacrylate) | Highly Similar |
| Material Shades | Common VITA-shades:A1, A2, A3, B1, B3, C3, D3, BL | Common VITA-shades | Common VITA-shades | Highly Similar |
| Biocompatible | Yes | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Rx | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Shelf-Life | 2 years | Not defined | Not defined | Not applicable |
| Chemical Composition | Methacrylate polymer resin with photoinitiator, and pigments | Polyurethane Resin; Methacrylate;Dimethacrylate; Phosphine oxide;Butylated hydroxytoluene; andPigments | (Meth)acrylate-based resin withphoto initiator and pigments | Highly Similar |
| Polymerization (Curing)Method | Visible light, 385 nmw/post curing | UV light, 405~412nmw/post curing | UV light, 405 nmw/post curing | Highly Similar |
| Equipment | Validated 3D-Printer and post curingdevices | Validated 3D-Printer and post curingdevices | Validated 3D-Printer and postcuring devices | Same |
| Performance Testing | ISO 4049:2019ISO 10477:2020 | ISO 4049:2013ISO 10477:2018 | ISO 4049:2013ISO 10477:2018 | Highly Similar |
| Depth of Cure | Hardness of bottom surface ≥70% topsurface | Not defined | Not defined | Highly Similar (meets requirementsof ISO 4049 and ISO 10477) |
| Surface Finish | Glossy surface after polishing | Not defined | Not defined | Highly Similar (meets requirementsof ISO 4049 and ISO 10477) |
| Flexural Strength | $≥ 100 MPa$ | Avg. 148.73 MPa | $≥ 100 MPa$ | Highly Similar (meets requirementsof ISO 4049 and ISO 10477) |
| Water Sorption | $≤ 40 µg/mm3$ | Avg. 13.03 µg/mm3 | $≤ 40 µg/mm3$ | Highly Similar (meets requirementsof ISO 4049 and ISO 10477) |
| Water Solubility | $≤ 7.5 µg/mm3$ | Avg. 1.00 µg/mm3 | $≤ 7.5 µg/mm3$ | Highly Similar (meets requirementsof ISO 4049 and ISO 10477) |
| Biocompatibility Testing | ISO 7405:2018ISO 10993-1:2018ISO 10993-3:2014ISO 10993-5:2009ISO 10993-10:2021ISO 10993-11:2017ISO 10993-17:2002ISO 10993-18:2020 | ISO 7405:2014ISO 10993-1:2018ISO 10993-3:2014ISO 10993-5:2009ISO 10993-6:2016ISO 10993-10:2013ISO 10993-11:2017 | TestedStandards not listed in 510(k)Summary document. | Highly Similar |
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The Technological Characteristics of the Subject and Predicate devices are the Same or Highly Similar.
Intended Use - The Subject and Predicate devices are same Highly Similar in their intended use, differing only in reference to the device name.
Material/Chemical Composition - The Subject and Predicate devices are same Highly Similar in they are both methacrylate polymer resins. Slight differences in chemical composition do not change the intended use of the Subject and Predicate devices to be used in the fabrication of permanent or temporary dental prostheses. The materials are an alternative to traditional heat cured and auto polymerization resins.
The Subject device has demonstrated suitability for intended use through material non-clinical performance testing.
Polymerization (Curing) Method - The Subject and Predicate devices are same Highly Similar in they are both light-cured polymer resins. Slight differences in the curing light wavelength does not changed use of the Subject and Predicate devices to be used in the fabrication of dental prostheses.
Performance Testing - The material performance standards used for testing the Subject and Predicate devices are highly similar, differing only in release date of the Subject device was tested to the most recent versions of ISO 4049 and ISO 10477. The material performance requirements of both standards did not change in the new release dates of each document. The Subject, Predicate and Reference devices all meet the material performance requirements of both the ISO 4049 and ISO 10477 documents.
Biocompatibility - The Subject and Predicate devices are similar in the standards and biological endpoints the devices were evaluated to. Slight differences in the standards and tested endpoints do not change the intended use of the Subject and Predicate devices.
Technological differences between the Subject and Predicate devices have been evaluated through non-clinical performance testing. The results of the tests performed show that Subject device meets the requirements mentioned in the applicable standards and confirm that the Subject device performs similarly to Predicate and Reference devices.
CLINICAL AND ANIMAL TESTING
The performance of methacrylate-based polymer resins in the clinical environment has been well established. No clinical or animal testing data is included in this submission.
NON-CLINICAL PERFORMANCE TESTING
Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input.
Physical property testing was performed on the Subject device to ISO 4049:2019, Dentistry — Polymer-based restorative materials and ISO 10477:2018, Dentistry – Polymer-based crown and veneering materials. Results
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demonstrated the Subject device meets the property requirements of the referenced standards. Comparative material property testing was performed with the Reference device demonstrating similar performance.
A biological evaluation was performed on the Subject device. Chemical characterization was performed to ISO 10993-18 with a risk assessment performed according to ISO 10993-17 and ISO/TS 21726. Biocompatibility testing was performed on the Subject device according to ISO 10993-1:2018 and ISO 7405:2014 according to the standards listed in the Technological Characteristics comparison table above.
An MRI safety assessment was performed on the Subject device to support MR Safety labeling as required by the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
Non-clinical performance testing of the Subject device met the acceptance criteria for each validation and test described above. This non-clinical performance testing demonstrates that the Subject device is suitable for intended use.
CONCLUSION
Overall, the Indications for Use statements for the Subject and Predicate devices are highly similar differing only in device name and slightly in use duration. Overall, the Technological Characteristics of the Subject device are the same or highly similar to the Predicate device with any differences mitigated through nonclinical performance testing.
Overall, these similarities between the Subject and Predicate devices, support a determination of substantial equivalence.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.