(4 days)
Not Found
No
The summary describes a light-curable resin used in a CAD/CAM system for fabricating dentures. It details the material composition, the printing process, and performance testing against standards. There is no mention of AI or ML being used in the design, manufacturing, or analysis process. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a light-curable resin used for fabricating and repairing dentures, which are prosthetics and not therapeutic in nature. Its function is to replace missing teeth and oral structures, not to treat a disease or condition.
No
The device is a light-curable resin used for fabricating and repairing dentures, which is a manufacturing process, not a diagnostic one. It is an alternative to traditional materials for creating physical dental prosthetics.
No
The device is a light-curable resin, which is a physical material used in a 3D printing process. While it is part of a CAD/CAM system that includes software, the device itself is a material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication and repair of dental prosthetics (dentures and baseplates). This is a manufacturing process for a medical device that is placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a material (resin) used in a 3D printing process to create a physical object (a denture). It doesn't describe a reagent, instrument, or system used to examine a specimen from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnosing diseases, or providing information about a patient's health status based on in vitro testing.
The device is a material used in the manufacturing of a medical device (a denture), which is regulated as a medical device, but not as an IVD.
N/A
Intended Use / Indications for Use
DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture02 requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a DLP (digital light processing) printer, and curing light equipment.
Product codes
EBI
Device Description
DIOnavi-Denture02 is a photo-cured resin intended to fabricate full and partial removable dentures in a CAD/CAM additive printing process. The material is an alternative to traditional heat cured and auto polymerization resins. It is denture base resins, Photo-cured product family comprises a family of dimethacrylate resins. The dimethacrylate resin is polymerized via photo initiators in a 3D printer. The color of the denture is determined by the addition of pigments. The material is used in a 3D printer, which prints the shape determined by a 3D drawing. After printed product is placed in a UV-light curing box for final polymerization. 3D printer and UV-light curing box is not included with the device.
The denture fabrication process begins with a traditional impression or optical impression of the oral region in the dentist office. This impression is sent to a dental lab. The denture base is then made layer-by-layer in a DLP (digital light processing) printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital impression
Anatomical Site
Oral region (for full and partial removable dentures and baseplates)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist office, dental lab
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 Testing: Performance tests in accordance with ISO 20795-1 including visual inspection, Weight, package inspection, dimensions, surface characteristics, translucency, color stability, flexural strength and flexural modulus, water sorption, water solubility and form porosity test. All results met the criteria of the standards.
Biocompatibility Testing: In accordance with ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, and ISO 10993-11. Tests included Cytotoxicity, Sensitization, Irritation reactivity, Genotoxicity, Sub-acute toxicity, and Material-mediated pyrogenicity.
Shelf Life Testing: Conducted with bench tests from ISO 20795-1, demonstrated a shelf life of 2 years.
No clinical testing was performed for this submission.
Key results: The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2021
DIO Corporation % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K210828
Trade/Device Name: DIOnavi-Denture02 Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: March 7, 2021 Received: March 19, 2021
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 (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.
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
1
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 (OS) 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 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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Indications for Use
510(k) Number (if known) K210828
Device Name DIOnavi-Denture02
Indications for Use (Describe)
DIOnavi-Denture02 is a light-curable resin indication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture(2 requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital light processing (DLP) printer, and curing light equipment.
| 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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K210828 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92
Submitter:
US Agent:
Ji-Ae, Park DIO Corporation 66 Centum seo-ro, Haeundae-gu, Busan, 48058, Republic of Korea japark@dio.co.kr Phone +82-51-745-7836
Peter Kang DIO USA 3470 Wilshire Blvd. #620, Los Angeles, CA, USA Email: peter@dioimplantusa.com Phone: 1-213-365-2875
Device Information:
Trade Name: DIOnavi-Denture02 Common Name: Light-cured denture resin Classification Name: Denture relining, repairing, or rebasing resin Product Code: EBI Panel: Dental Regulation Number: 21 CFR 872.3760 Device Class: Class II Date prepared: March. 17. 2021
General Description
DIOnavi-Denture02 is a photo-cured resin intended to fabricate full and partial removable dentures in a CAD/CAM additive printing process. The material is an alternative to traditional heat cured and auto polymerization resins. It is denture base resins, Photo-cured product family comprises a family of dimethacrylate resins. The dimethacrylate resin is polymerized via photo initiators in a 3D printer. The color of the denture is determined by the addition of pigments. The material is used in a 3D printer, which prints the shape determined by a 3D drawing. After printed product is placed in a UVlight curing box for final polymerization. 3D printer and UV-light curing box is not included with the device.
The denture fabrication process begins with a traditional impression or optical impression of the oral region in the dentist office. This impression is sent to a dental lab. The denture base is then made layer-bylayer in a DLP (digital light processing) printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.
Indication For Use
DIOnavi-Denture02 is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with DIOnavi-Denture02 requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a DLP (digital light processing) printer, and curing light equipment.
Predicate devices
The subject device is substantially equivalent to the following Predicate Device: Primary Predicate Device : DIOnavi-Denture (K193623)
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Summaries of Technological Characteristics
The subject device is substantially equivalent to the currently cleared devices. They are substantially equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection type. Comparison demonstrating Substantial Equivalence follows:
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Applicant | DIO Corporation | DIO Corporation |
| Trade Name | DIOnavi-Denture02 | DIOnavi-Denture |
| 510(K) No. | Not yet assigned | K193623 |
| Regulation | ||
| Name | Denture Relining, Repairing, Or Rebasing | |
| Resin | Denture Relining, Repairing, Or Rebasing | |
| Resin | ||
| Product Code | EBI | EBI |
| Class | Class II | Class II |
| Device | ||
| Identification | Light-cured resin | Light-cured resin |
| Indications for | ||
| Use | DIOnavi-Denture02 is a light-curable resin | |
| indicated for fabrication and repair of full | ||
| and partial removable dentures and | ||
| baseplates. The material is an alternative to | ||
| traditional heat-curable and auto | ||
| polymerizing resins. Fabrication of dental | ||
| prosthetics with DIOnavi-Denture02 | ||
| requires a computer-aided design and | ||
| manufacturing (CAD/CAM) system that | ||
| includes the following components: digital | ||
| denture base files based on a digital | ||
| impression, a digital light processing (DLP) | ||
| printer, and curing light equipment. | DIOnavi-Denture is a light-curable resin | |
| indicated for fabrication and repair of full | ||
| and partial removable dentures and | ||
| baseplates. The material is an alternative to | ||
| traditional heat-curable and auto | ||
| polymerizing resins. Fabrication of dental | ||
| prosthetics with DIOnavi-Denture requires a | ||
| computer-aided design and manufacturing | ||
| (CAD/CAM) system that includes the | ||
| following components: digital denture base | ||
| files based on a digital impression, a digital | ||
| light processing(DLP) printer, and curing | ||
| light equipment. | ||
| Chemical | ||
| composition | Dimethacrylate-based resins with photo- | |
| initiator, and pigments. | Dimethacrylate-based resins with photo- | |
| initiator, and pigments. | ||
| Chemical | ||
| formulation | Pre-mixed liquid resin provided in a | |
| container | Pre-mixed liquid resin provided in a | |
| container | ||
| Polymerization | ||
| (Curing) | ||
| Method | Visible light | Visible light |
| Fabrication of | ||
| Denture Base | Automated 3D printing of resin in multiple | |
| layers, each light-cured before adding next | ||
| layer, with post curing in light chamber | Automated 3D printing of resin in multiple | |
| layers, each light-cured before adding next | ||
| layer, with post curing in light chamber | ||
| Post Curing | Visible light-curing unit | Visible light-curing unit |
| Product State | Pre-mixed resin (liquid) | Pre-mixed resin (liquid) |
| Teeth | ||
| Assemble | Bonding | Bonding |
| Sterilization | Non-sterile | Non-sterile |
| Shelf-life | 2 years | 2 years |
| Device | ||
| Characteristics | Automated 3D printing of resin in multiple | |
| layers, each light-cured before adding next | ||
| layer, with post curing in light chamber. | Automated 3D printing of resin in multiple | |
| layers, each light-cured before adding next | ||
| layer, with post curing in light chamber. | ||
| Substantial | ||
| Equivalence | The indications for use and the technological characteristics are the same between the | |
| Equivalence | subject device and the predicate device. The subject device and the predicate device use | |
| Discussion | similar technologies to make the final dentures and base plates, including the type of printer |
5
| used. Both devices use digital light processing(DLP) printer. The physical properties and the |
|---|
| steps in the process are also similar. The indications for Use Statement is exactly the same as |
| the predicate device. They using a same type of raw material as Dimethacrylate-based resin. |
| There might be differences in formulation, however, we have performed biocompatibility |
| tests in accordance with ISO 10993 and performance tests in accordance with ISO 20795-1. |
| All of the test results met the criteria and demonstrated that this difference would not raise a |
| question in substantial equivalence and the subject device would perform as well as the |
| predicate devices. Based on the information submitted herein. we conclude that the subject |
| device is substantially equivalent to the predicate device. |
Non-clinical Testing
Performance tests in accordance with ISO 20795-1 including visual inspection, Weight, package inspection, dimensions, surface characteristics, shape capability, translucency, color stability, flexural strength and flexural modulus, water sorption, water solubility and form porosity test.
The subject device used for the preparation of the test specimen was manufactured using a digital light processing (DLP) 3D printer. The following printer(s) is validated for processing (3D printing) using DIOnavi-Denture02.
- Manufacturer : DIO Corporation -
- Name of printer : DIO PROBO -
- Model number : PROBO -
Additional printers post-510(k) clearance will be added to the labelling by means of the Quality Systems and within the company's validation plan.
The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device.
Shelf Life Testing
Subject device has a shelf life of 2 years. The shelf-life testing has been conducted with the bench tests from ISO 20795-1.
Biocompatibility
Biocompatibility Tests in accordance with "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"Guidance for Industry and Food and Drug Administration StaffSEPTEMBER 2020"
Subject device is considered a surface device, in contact with the mucosal membrane, for > 30 days. The ISO 10993-1 standard was followed and the following biological safety aspects have been addressed: Cytotoxicity in accordance with ISO 10993-5 Sensitization in accordance with ISO 10993-10 Irritation reactivity test in accordance with ISO 10993-10 Genotoxicity test in accordance with ISO 10993-3 Sub-acute toxicity in accordance with ISO 10993-11 Material-mediated pyrogenicity in accordance with ISO 10993-11
Summary of clinical testing
No clinical testing was performed for this submission.
Conclusions
The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences. Based on the information provided in this premarket notification. DIO Corporation concludes that the DIOnavi-Denture02 is substantially equivalent to the predicate device as described herein in.