(3 days)
Not Found
No
The summary describes a 3D printable denture base resin and the associated printing and curing process. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the material properties and the 3D printing process.
No.
The device is a material (resin) used for fabricating dentures, which are prosthetic devices, not therapeutic devices that treat or prevent disease.
No
Explanation: The device is a light-curable resin used for fabricating dentures, which is a restorative rather than a diagnostic function.
No
The device is a physical material (resin) used in conjunction with hardware (3D printer and post-curing unit) to fabricate dentures. It is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fabrication of full and partial removable dentures." This is a manufacturing process for a medical device (a denture), not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a "liquid light-curable material" used in a 3D printing process to create a physical object (a denture base). It doesn't interact with biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: The description does not mention any components, processes, or intended uses related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties (meeting ISO standards for denture base polymers), and shelf-life. These are relevant to the safety and performance of a manufactured medical device, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used to create a physical prosthetic device.
N/A
Intended Use / Indications for Use
Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture bases with Denture Base Resin requires a digital denture file, 3D printer and post-curing unit.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Denture Base Resin is a liquid light-curable material. The product should be used in combination with the 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. The 3D printer and the post-curing unit of SHINING3D make use of a light source to polymerize the Denture Base Resin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital Dental (technical) laboratory.
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)
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 Surface device in contact with mucosal membrane with permanent contact (>30 d). The subject device was evaluated for: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Subacute/subchronic systemic toxicity, Implantation, Material-mediated pyrogenicity, Genotoxicity.
Performance Bench Testing: Performance testing was conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Denture Base Resin complies with the following standards: ISO 20795-1: 2013 Dentistry—Base polymers —Part 1: Denture base polymers . ISO 7491: 2000 Dental materials-Determination of color stability.
Shelf-Life: The shelf life of the Denture Base Resin is 2 years. The test was performed in accordance with ASTM F1980-16.
Clinical Test Conclusion:
No clinical study is included in this submission.
Key results: The Denture Base Resin is as safe and effective as its predicate device. The Denture Base Resin has similar intended use and technological characteristics. The minor differences between the Denture Base Resin and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Denture Base Resin is as safe and effective as the predicate device. Thus, the Denture Base Resin is substantially equivalent.
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
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March 31, 2025
Hangzhou SHINING3D Dental Technology Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K250946
Trade/Device Name: Denture Base Resin DT20 Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: March 28, 2025 Received: March 28, 2025
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.
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 (OS) 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.
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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory
2
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
3
Indications for Use
510(k) Number (if known) K250946
Device Name Denture Base Resin DT20
Indications for Use (Describe)
Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture base Resin requires a digital denture file, 3D printer and post-curing unit.
| 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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K250946
510(k) Summary
I Submitter
| Submitter Name: | Hangzhou SHINING3D Dental Technology Co., Ltd |
|---|---|
| Submitter Address: | 9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan, |
| Hangzhou, Zhejiang, China | |
| Contact person: | Name: Yuzhuo Wang |
| Title: Regulatory Affairs Specialist | |
| Phone: +86 15005173276 | |
| Email: wangyuzhuo@shining3d.com | |
| Date Prepared: | February 15, 2025 |
II Subject Device
| Trade Name of Device: | Denture Base Resin DT20 |
|---|---|
| Common Name | Denture Base Resin |
| Classification Name(s): | Resin, Denture, Relining, Repairing, Rebasing |
| Model: | DT20-OR, DT20-LRP, DT20-LT |
| Regulation Number: | 21 CFR 872.3760 |
| Product Code: | EBI |
| Regulatory Class | Class II |
| Submission number: |
III Predicate Device
| Trade name: | NextDent Denture 3D+ |
|---|---|
| Common and | |
| Classification Name(s): | Resin, Denture |
| Classification: | 21 CFR 872.3760 |
| Regulatory class: | Class II |
| Product code: | EBI |
| Submitter Name: | Vertex-Dental B.V. |
| 510(k) number: | K191497 |
IV Device description
Denture Base Resin is a liquid light-curable material. The product should be used in combination with the 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. The 3D printer and the post-curing
5
unit of SHINING3D make use of a light source to polymerize the Denture Base
Resin.
| 3D Printer | |
|---|---|
| Brand | Model |
| SHINING 3D | AccuFab-D1s, AccuFab-C1s |
| Post-curing Unit | |
| Brand | Model |
| SHINING 3D | FabCure 2 |
The 3D printer and the post-curing unit of SHINING3D are not included with the device.
V Intended Use /Indications for use
Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture bases with Denture Base Resin requires a digital denture file, 3D printer and post-curing unit.
VI Available model
| Model | Color Code |
|---|---|
| DT20-OR | OR |
| DT20-LRP | LRP |
| DT20-LT | LT |
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VII Comparison to predicate devices
| Item | Subject Device | Predicate device
(K191497) | Discussion |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Denture Base Resin DT20 | NextDent Denture 3D+ | / |
| Classification | Class II | Class II | Same |
| Product Code | EBI | EBI | Same |
| Regulation | 21 CFR 872.3760 | 21 CFR 872.3760 | Same |
| Indications for
Use/Intended
Use | Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures.
Fabrication of denture bases with Denture Base Resin requires a digital denture file, 3D printer and post-curing unit. | NextDent Denture 3D+ is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent Denture 3D+ is intended exclusively for professional dental work. Fabrication of denture bases with NextDent Denture | Similar
Both the subject and predicate devices are alternatives to traditional heat cured and auto polymerization resins, and are light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The predicate device uses a scanner in order to obtain digital denture files, same as the subject device. |
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| Item | Subject Device | Predicate device
(K191497) | Discussion | | | | | | | | | | | | | | | | |
|-----------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | | 3D+ requires a computer-aided and
manufacturing (CAD/CAM) system that
includes the following scanner, design
software, additive printer and post-cure
unit: | Thus, the intended use of the
subject and predicate devices
is substantially the same. | | | | | | | | | | | | | | | | |
| | | Design:
Scanner Brand
3Shape Type
D900 Software Design software Brand
3Shape Type
Dental-System 2016 Premium Printing:
Printer Brand
3D Systems Type
NextDent 5100 Figure4® Software
3D Sprint Post-curing:
Post-cure unit Brand
NextDent Type
LC-3DPrint Box Software
n.a. | | | | | | | | | | | | | | | | | |
| Printer Device | AccuFab-D1s, AccuFab-C1s | NextDent 5100 Figure 4® | Similar
Compatible printer types
have been verified for the
subject device. | | | | | | | | | | | | | | | | |
| Post-curing
Device | FabCure 2 | LC- 3D Print Box | Similar
Compatible post-curing
device types have been
verified for the subject
device | | | | | | | | | | | | | | | | |
8
| Item | Subject Device | Predicate device
(K191497) | Discussion |
|-------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material
Composition | Methacrylate-based resins,
photo-initiator and pigments. | Methacrylate-based resins with
photo-initiator, filler and pigments. | Similar
Compared to predicate
devices, subject devices have
no filler. The filler is used to
adjust the mechanical
properties, as can acrylates.
And the subject equipment
passes a bench test that
shows that the performance
meets the standard
requirements. |
| Material Type | Light-curable Resin | Light-curable Resin | Same |
| Curing Method | UV Light | UV Light | Same |
| Product State | Liquid | Liquid | Same |
| Manufacturing
Technology
Type | Additive | Additive | Same |
| Shelf-Life | 2 years | 2 years | Same |
| Environment of
Use | Healthcare facility/hospital
Dental (technical) laboratory. | Healthcare facility/hospital
Dental (technical) laboratory. | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Performance
Testing | Meets the performance standards for
Type 4 denture base polymer per ISO | Meets the performance standards for
Type 4 denture base polymer per ISO | Same |
9
| Item | Subject Device | Predicate device
(K191497) | Discussion |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 20795- 1. | 20795- 1. | |
| Biocompatibility
Testing | Denture Base Resin is considered a
surface device, in contact with the
mucosal membrane, for > 30 days.
Tested to ISO 7405, ISO 10993-1
Cytotoxicity (Part 5)
Sensitization (Part 10)
Irritation (Part 23)
Subacute/subchronic systemic
toxicity (Part 11)
Genotoxicity (Part 3)
Acute systemic toxicity (Part 11)
Pyrogen Test (Part 11)
Implantation (Part 6) | NextDent™ Denture 3D+ is considered
a surface device, in contact with the
mucosal membrane, for > 30 days.
Tested to ISO 10993-1
Cytotoxicity (Part 5)
Sensitization (Part 10)
Irritation or intracutaneous reactivity
(Part 10)
Subacute/subchronic systemic toxicity
(Part 11)
Genotoxicity (Part 3) | Similar
The subject device takes into
account the applicable ISO
7405 standard. Based on ISO
10993-1 and ISO 7405, acute
systemic toxicity, pyrogen and
implantation tests are
included. |
10
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 Surface device in contact with mucosal membrane with permanent contact (>30 d). The subject device was evaluated for:
- Cytotoxicity Sensitization Irritation Acute systemic toxicity Subacute/subchronic systemic toxicity Implantation Material-mediated pyrogenicity Genotoxicity
Performance Bench Testing:
Performance testing was conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device.
The test results demonstrated that the Denture Base Resin complies with the following standards:
- ISO 20795-1: 2013 Dentistry—Base polymers —Part 1: Denture base polymers .
- ISO 7491: 2000 Dental materials-Determination of color stability. ●
Shelf-Life: _
The shelf life of the Denture Base Resin is 2 years. The test was performed in accordance with ASTM F1980-16.
11
Clinical Test Conclusion
No clinical study is included in this submission.
IX Conclusion
The Denture Base resin is as safe and effective as its predicate device. The Denture Base Resin has similar intended use and technological characteristics. The minor differences between the Denture Base Resin and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Denture Base Resin is as safe and effective as the predicate device. Thus, the Denture Base Resin is substantially equivalent.