(84 days)
Not Found
No
The summary describes a material (resin) and the manufacturing process (CAD/CAM, 3D printing) for dentures. There is no mention of AI or ML being used in the design, manufacturing, or analysis of the device or patient data. The process relies on clinician judgment and standard CAD/CAM workflows.
No.
A therapeutic device is one that treats a disease or condition. This device is used to fabricate dentures, which are prosthetics that replace missing teeth, rather than treating a disease or condition itself.
No
Explanation: The device is a resin used for fabricating and repairing dentures, which are prosthetic devices, not diagnostic ones. It is used to create a physical product based on a clinician's judgment, rather than to identify or characterize a disease or condition.
No
The device is a physical resin material used for fabricating dentures, not a software program. While it is used in conjunction with digital design and manufacturing systems, the device itself is the curable resin.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device's Intended Use: The Denture Base resin is intended for the fabrication and repair of full and partial removable dentures and baseplates. This is a manufacturing process for a medical device (a denture), not a diagnostic test performed on a human specimen.
- Device Description: The description focuses on the material properties, the manufacturing process (using a 3D printer and scanned images), and the intended use in the oral cavity. There is no mention of analyzing biological samples.
- Input: The input is a scanned 3D image of the patient's teeth, which is used for design and manufacturing, not for diagnostic analysis of a biological sample.
The device is a material used in the creation of a medical device (a denture), which is then placed in the patient's oral cavity. This falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Product codes
EBI
Device Description
Fabrication of dental prosthetics with Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
The Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
Denture Base resin is intended exclusively for professional dental work.
Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians in dental offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing: The biocompatibility evaluation for Denture Base was conducted in accordance with the International Standard ISO 10993-1, as recognized by FDA. The battery of testing included the following tests: Cytotoxicity, Genotoxicity, Acute Systematic Toxicity, Subchronic toxicity, Irritation, Sensitization. Denture Base is categorized as Surface Devices in contact with mucosal membrane with a contact duration of long time>30 days.
Bench Testing: Denture Base was tested for conformity with the industry consensus standard ISO 20795-1. The battery of testing included the following tests: Ultimate Flexural Strength and Modulus, Water Sorption and Solubility, Residual Methyl Methacrylate Monomers, Homogeneity, Surface Characteristics, Shape Capability, Translucency, and Polishability, Colour, Freedom from Porosity, Color Stability, Maximum stress intensity factor, Total fracture work, Bonding to synthetic polymer teeth. In all instances, Denture Base functioned as intended and the outcomes were as expected.
Additive Manufacturing: Testing, according to FDA's guidance Technical Considerations for Additive Manufactured Medical Devices, was performed and results were provided in the 510(k). These tests included evaluation of all relevant properties of the printed resin using the permitted machines. Further, tests based on considerations of the orientation during manufacturing were performed.
Key Results: Performance data demonstrate that the Denture Base is as safe and effective as the predicate device. Thus, the Denture Base is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SprintRay High Impact Denture Base(K221678)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 23, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA name on the right. The seal includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The FDA name is written in blue and includes the words "U.S. FOOD & DRUG ADMINISTRATION".
Riton 3D Technology Co., Ltd Reanny Wang General Manager Room C101, Building 2, No. 21, Hejing South Road Liwan District Guangzhou, Guangdong 51038 China
Re: K243103
Trade/Device Name: Denture Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: September 25, 2024 Received: September 30, 2024
Dear Reanny Wang:
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.
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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., 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
Submission Number (if known)
Device Name
Denture Base
Indications for Use (Describe)
Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
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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510(K) SUMMARY
Denture Base (K243103)
| Submitter: | Riton 3D Technology Co., Ltd
Room C101, Building 2, No. 21, Hejing South Road
Liwan District Guangzhou, Guangdong CN 51038 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +86-20-81509265 |
| Contact Person: | YongMing Sun |
| Date Prepared: | Sep. 25, 2024 |
| Name of Device: | Denture Base |
| Common or Usual Name: | Denture Base, Prescription |
| Classification Name: | Resin, Denture, Relining, Repairing, Rebasing |
| Regulation Description: | Denture relining, repairing, or rebasing resin |
| Device Class: | Class 2 |
| Regulation Number: | 21 CFR 872.3760 |
| Product Code: | EBI |
| Primary Predicate Device: | SprintRay High Impact Denture Base(K221678) |
| Device Description: | |
Fabrication of dental prosthetics with Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
The Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
Denture Base resin is intended exclusively for professional dental work.
Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
Intended Use / Indications for Use
Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Summary of Technological Characteristics
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Light curing of a 3D printed acrylate resin is the technological principle for both the subject and predicate devices. The Denture Base is poured into a 3D printer, which relies on scanned images of the patient's oral cavity to produce a dental appliance.
The following technological differences exist between the subject and predicate devices:
- . Differences in acrylate resin material
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for Denture Base was conducted in accordance with the International Standard ISO 10993-1, as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity ●
- Genotoxicity ●
- Acute Systematic Toxicity ●
- Subchronic toxicity ●
- Irritation ●
- Sensitization ●
Denture Base is categorized as Surface Devices in contact with mucosal membrane with a contact duration of long time>30 days
Bench Testing
Denture Base was tested for conformity with the industry consensus standard ISO 20795-1. The battery of testing included the following tests:
- Ultimate Flexural Strength and Modulus ●
- Water Sorption and Solubility ●
- Residual Methyl Methacrylate Monomers ●
- Homogeneity ●
- Surface Characteristics ●
- Shape Capability
- Translucency, and Polishability
- Colour ●
- Freedom from Porosity ●
- Color Stability ●
- Maximum stress intensity factor
- Total fracture work ●
- Bonding to synthetic polymer teeth ●
In all instances, Denture Base functioned as intended and the outcomes were as expected.
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| Feature | Subject Device (K243103) | Primary Predicate Device (K221678) | Comparison |
|---|---|---|---|
| Product Name | Denture Base | SprintRay High Impact Denture Base | N/A |
| 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 and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material. | The SprintRayHigh Impact Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material. | Same |
| User Population | Clinicians in dental offices | Clinicians in dental offices | Same |
| Chemical Description | Methacrylate-based resin | Methacrylate-based resin | Similar |
| 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 |
| Volume provided | 1kg/bottle | 1kg bottle | Same |
| Shelf life | 2 years | 1.5 years | Similar |
| Standards | ISO 20795-01 | ISO 20795-01 | Same |
| Physical and Mechanical Properties | Ultimate Flexural Strength and Modulus | Flexural Strength and Modulus | Similar |
| Water Sorption and Solubility | Water Sorption and Solubility | ||
| Residual Methyl Methacrylate Monomers | Residual Methyl Methacrylate Monomers | ||
| Homogeneity | Homogeneity | ||
| Surface Characteristics | Surface Characteristics | ||
| Shape Capability | |||
| Translucency, and Polishability | |||
| Colour | |||
| Freedom from Porosity | Shape Capability, | ||
| Translucency, and Polishability | |||
| Freedom from Porosity | |||
| Color Stability | |||
| Color Stability | |||
| Maximum stress intensity factor | |||
| Total fracture work | |||
| Bonding to synthetic polymer teeth | |||
| Tested to ISO-10993-1 | Tested to ISO7405, ISO-10993-1 | ||
| Biocompatibility | Genotoxicity (Part 3) | Genotoxicity (Part 3) | |
| Cytotoxicity(Part 5) | Cytotoxicity (Part 5) | ||
| Sensitization (Part 10) | Acute Systematic Toxicity(Part 11) | Similar | |
| Acute Systematic Toxicity(Part 11) | Sensitization (Part 10) | ||
| Subchronic toxicity(Part 11) | Irritation (Part 10) | ||
| Irritation (Part 23) | |||
| Additive | |||
| Manufacturing | Testing, according to FDA's | ||
| guidance Technical Considerations | |||
| for Additive Manufactured Medical | |||
| Devices, was performed and results | |||
| were provided in the 510(k). These | |||
| tests included evaluation of all | |||
| relevant properties of the printed | Testing, according to FDA's guidance | ||
| Technical Considerations for Additive | |||
| Manufactured Medical Devices, was | |||
| performed and results were provided in | |||
| the 510(k). These tests included | |||
| evaluation of all relevant properties of the | |||
| printed resin using the permitted | Same | ||
| resin using the permitted machines. | |||
| Further, tests based on considerations | |||
| of the orientation during | |||
| manufacturing were performed. | machines. Further, tests based on | ||
| considerations of the orientation during | |||
| manufacturing were performed. | |||
| PrinterDevice | RXDent-L230 3D printer | SprintRay Pro 95 | Similar |
| Post-Cure | |||
| Device | RXDent-W90(s) | SprintRay ProCure 2 | Similar |
| Sterility | Non-sterile | Non-sterile | Same |
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Conclusions
The Denture Base resin is as safe and effective as its predicate device. The Denture Base has the same intended use and indication, and similar technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Denture Base and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Denture Base is as safe and effective as the predicate device. Thus, the Denture Base is substantially equivalent.