Dura-Arch
Device Facts
| Record ID | K261261 |
|---|---|
| Device Name | Dura-Arch |
| Applicant | Hangzhou SHINING3D Dental Technology Co., Ltd. |
| Product Code | EBG · Dental |
| Decision Date | Apr 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3770 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Indications for Use
The product is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and preformed denture teeth to be used in a denture.
Device Story
Dura-Arch is a liquid photo-curable (meth)acrylate resin used for additive manufacturing of temporary dental restorations and denture teeth. Operated by dental professionals using a validated SHINING3D printer; the device transforms liquid resin into solid structures through layer-by-layer light-curing (free radical polymerization) followed by post-curing in a dedicated device. The output is a custom-fabricated dental prosthesis. The device benefits patients by providing temporary restorative solutions. Clinical decision-making is supported by the physical properties of the cured resin, which meets dental standards for temporary use.
Clinical Evidence
No clinical data. Bench testing only. Performance evaluated per ISO 4049:2019, ISO 10477:2020, and ISO 22112:2017. Biocompatibility testing conducted per ISO 10993-1:2018 and ISO 7405:2018, including cytotoxicity, sensitization, irritation, reactivity, systemic toxicity, implantation, pyrogen, and genotoxicity tests. Shelf-life validated per ASTM F1980-21.
Technological Characteristics
Liquid (meth)acrylate oligomer/monomer resin with photoinitiators, pigments, and absorbers. Curing via UV light (extra-oral). Additive manufacturing process. Complies with ISO 4049, ISO 10477, ISO 22112, and ISO 10993-1. Non-sterile. 2-year shelf life (ASTM F1980-21).
Indications for Use
Indicated for professional dental use in the fabrication of temporary dental restorations and preformed denture teeth via additive manufacturing.
Regulatory Classification
Identification
A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
Predicate Devices
- GR-17 Resin System (K201827)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 17, 2026
Hangzhou SHINING3D Dental Technology Co., Ltd.
% Dave Yungvirt
CEO
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison, New Jersey 07940
Re: K261261
Trade/Device Name: Dura-Arch
Regulation Number: 21 CFR 872.3770
Regulation Name: Temporary crown and bridge resin
Regulatory Class: Class II
Product Code: EBG PZY
Dated: April 16, 2026
Received: April 16, 2026
Dear Dave Yungvirt:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261261 - Dave Yungvirt
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the Medical Device File (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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K261261 - Dave Yungvirt
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assistance/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 -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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K261261 | |
| Device Name Dura-Arch | |
| Indications for Use (Describe) The product is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and preformed denture teeth to be used in a denture. | |
| 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) | |
| 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." | |
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K261261
# 510(k) Summary
## I Submitter
Submitter Name: Hangzhou SHINING3D Dental Technology Co., Ltd.
Establishment 3026312357
Registration Number:
Submitter Address: 9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan, Hangzhou, Zhejiang, 311258, China
Contact Person: Chen Yuqi
Title: Regulatory Affairs Specialist
Phone: +86 18868106483
Email: chenyuqi@shining3d.com
Date Prepared: April 1, 2026
## II Device
Device Name: Dura-Arch
Model: CX200-A1 / CX200-A2 / CX200-B1 / CX200-BL
Regulation Name: Temporary Crown and Bridge Resin
Regulation Number: 21 CFR 872.3770
Regulatory Class: Class II
Product Code: EBG, PZY
Review Panel: Dental
## III Predicate Device
Trade/Device Name: GR-17 Resin System
Regulation Name: Temporary Crown and Bridge Resin
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Regulation Number: 21 CFR 872.3770
Regulatory Class: Class II
Product Code: EBG, PZY
Submitter Name: Pro3dure Medical GmbH
510(k) Number: K201827
## IV Device description
The product should be used in combination with SHINING3D printer. The product is a liquid photo-curable material, which is produced by free radical polymerization of oligomers triggered by photoinitiator contained in the resin. The resin is printed in multiple layers automatically, with each layer being subjected to light curing before the addition of the next layer, and then undergoes post-curing in a curing device. The product is intended exclusively for professional dental work.
## V Intended Use /Indications for use
The product is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and preformed denture teeth to be used in a denture.
## VI Available model
| Model | Color |
| --- | --- |
| CX200-A1 | A1 |
| CX200-A2 | A2 |
| CX200-B1 | B1 |
| CX200-BL | 0M2 |
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# VII Comparison to predicate devices
The subject device is as safe and effective as its predicate device. It shares the same or similar intended use, chemical description, manufacturing and curing method etc., with performance characteristics that are either identical or substantially equivalent to those of predicate device.
Additionally, the subject device is indicated for the fabrication of preformed denture teeth to be used in a denture, which fall under the product code "PZY" (Additively Manufactured, Preformed, Resin Denture Tooth) and are 510k exempt, therefore out of the scope of this submission.
The following table shows comparison between the subject and predicate device.
| Item | Subject Device | Predicate Device (K201827) | Remark |
| --- | --- | --- | --- |
| Product Name | Dura-Arch | GR-17 Resin System | -- |
| Regulation Name | Temporary Crown and Bridge Resin | Temporary Crown and Bridge Resin | Same |
| Product Code | EBG, PZY | EBG, PZY | Same |
| Regulation Number | 21 CFR 872.3770 | 21 CFR 872.3770 | Same |
| Regulatory Class | Class II | Class II | Same |
| Indication for Use /Intended Use | The product is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and preformed denture teeth to be used in a denture. | The GR-17 Resin System is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment.
The GR-17 temporary is indicated for the fabrication, by additive | Similar |
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| | | manufacturing, of temporary anterior dental restorations. The GR-17.1 temporary is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and for the fabrication, by additive manufacturing, of preformed denture teeth to be used in a denture. | |
| --- | --- | --- | --- |
| Chemical Description | Dura-Arch consists of (meth)acrylate oligomers and monomers, photo-initiator, pigments and absorbers. | Methacrylate- based resin | Similar |
| Acrylic Resin | Extra-oral light cure resin | Extra-oral light cure resin | Same |
| Manufacturing | Additive | Additive | Same |
| Curing Method | UV Light | UV Light | Same |
| Product State | Liquid | Liquid | Same |
| Equipment | Validated 3D-Printer and post curing devices | Validated 3D-Printer and post curing devices | Same |
| Shelf-Life | 2 years | 2 years | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Performance Testing | ISO 4049:2019
ISO 10477:2020
ISO 22112:2017 | ISO 4049:2019
ISO 10477:2020
ISO 22112:2017 | Same |
| Flexural Strength | ≥ 50 MPa | ≥ 100 MPa | Similar |
| Water Sorption | ≤ 40 μg/mm³ | ≤ 40 μg/mm³ | Same |
| Solubility | ≤ 7.5 μg/mm³ | ≤ 7.5 μg/mm³ | Same |
| Biocompatibility Testing | Comply with ISO 10993-1:2018, and ISO 7405:2018 | Comply with ISO 10993-1:2018, and ISO 7405:2018 | Same |
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VIII Summary of Testing (Performance Data):
## Non-Clinical Performance Test Conclusion
## Biocompatibility testing
Based on ISO 10993-1 and ISO 7405, the subject device is categorized as a surface device in contact with mucosal membrane with Long-term contact (>30d). The subject device was evaluated for:
- Cytotoxicity Test
- Sensitization Test
- Oral Mucosa Irritation Test
- Intracutaneous Reactivity Test
- Acute Systemic Toxicity Test
- Subchronic Systemic Toxicity Test
- Implantation Test
- Pyrogen Test
- Genotoxicity Test
## Performance Bench Testing:
Physical and mechanical properties of the subject device were evaluated according to:
- ISO 4049:2019 Dentistry - Polymer-based restorative materials
- ISO 10477:2020 Dentistry - Polymer-based crown and veneering materials.
- ISO 22112:2017 Dentistry - Artificial teeth for dental prostheses
The test results demonstrated the Subject device meets the property requirements of the referenced standards.
Validation of the manufacturing process and compatible equipment was performed demonstrating consistency of the process output with that of the process input.
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## Shelf-Life Testing:
The shelf-life of the Dura-Arch is 2 years. Testing was performed in accordance with ASTM F1980-21.
## Clinical Test Conclusion:
No clinical study is included in this submission.
## IX Conclusion
The subject device is as safe and effective as its predicate device. It shares the same or similar intended use, chemical description, manufacturing and curing method etc., with performance characteristics that are either identical or substantially equivalent to those of predicate device.
The minor differences among the subject device and predicate device have not raised extra safety and performance concerns, based on the relevant tests and evaluations provided in this submission. Performance data confirm that the subject device demonstrates equivalent safety and effectiveness to the predicate device.
Thus, the Dura-Arch is substantially equivalent.
