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.

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 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.

AI/ML Overview

The provided text is related to a 510(k) submission for a dental device (DIOnavi-Denture02), which is a light-curable resin for fabricating and repairing dentures. The document details the regulatory review process and the basis for the FDA's substantial equivalence determination.

However, the provided text does not describe a study that uses AI/ML or performs human reader improvement studies (MRMC study) or standalone AI performance. The studies mentioned are non-clinical performance tests (e.g., flexural strength, water sorption) and biocompatibility tests (e.g., cytotoxicity, sensitization) to demonstrate that the new device is substantially equivalent to a predicate device based on material properties and performance characteristics relevant to dental resins.

Therefore, many of the requested points regarding acceptance criteria and studies for AI/ML devices, such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone AI performance, cannot be extracted from this document as they are not relevant to the type of device and study described.

The document specifically states: "No clinical testing was performed for this submission." This further reinforces that the type of study typically associated with AI/ML device approval (which often involves clinical data and human reader performance analysis) was not conducted or required for this dental resin.

Based on the provided text, here is what can be extracted regarding the "acceptance criteria" and "study" as applicable to this type of medical device submission:

1. A table of acceptance criteria and the reported device performance:

The document lists performance tests in accordance with ISO 20795-1 and states that the "results have met the criteria of the standards." It does not provide a table with specific acceptance values and corresponding device performance values.

Acceptance Criteria Category	Specific Tests/Standards Met	Reported Device Performance
Non-clinical Performance	Visual inspection (ISO 20795-1)	Met criteria of the standards
	Weight (ISO 20795-1)	Met criteria of the standards
	Package inspection (ISO 20795-1)	Met criteria of the standards
	Dimensions (ISO 20795-1)	Met criteria of the standards
	Surface characteristics (ISO 20795-1)	Met criteria of the standards
	Shape capability (ISO 20795-1)	Met criteria of the standards
	Translucency (ISO 20795-1)	Met criteria of the standards
	Color stability (ISO 20795-1)	Met criteria of the standards
	Flexural strength (ISO 20795-1)	Met criteria of the standards
	Flexural modulus (ISO 20795-1)	Met criteria of the standards
	Water sorption (ISO 20795-1)	Met criteria of the standards
	Water solubility (ISO 20795-1)	Met criteria of the standards
	Form porosity test (ISO 20795-1)	Met criteria of the standards
Biocompatibility	Cytotoxicity (ISO 10993-5)	Addressed (implied criteria met for clearance)
	Sensitization (ISO 10993-10)	Addressed (implied criteria met for clearance)
	Irritation reactivity test (ISO 10993-10)	Addressed (implied criteria met for clearance)
	Genotoxicity test (ISO 10993-3)	Addressed (implied criteria met for clearance)
	Sub-acute toxicity (ISO 10993-11)	Addressed (implied criteria met for clearance)
	Material-mediated pyrogenicity (ISO 10993-11)	Addressed (implied criteria met for clearance)
Shelf Life	Bench tests from ISO 20795-1 on aged samples	2 years (subject device has a shelf life of 2 years)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified for non-clinical or biocompatibility tests. These are typically material property tests, not patient data tests.
Data Provenance: Not applicable in the context of patient data, as the tests relate to the physical and chemical properties of the resin itself, not clinical outcomes from human subjects. The manufacturer is based in Republic of Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth in this context refers to the defined standards (e.g., ISO 20795-1, ISO 10993 series) for material properties and biocompatibility, not expert consensus on medical images or clinical diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human readers or clinical interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states: "No clinical testing was performed for this submission." This type of study is not relevant to the approval of a dental resin as a material.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" or reference standards are the international standards for dental materials (ISO 20795-1) for physical and mechanical properties and biocompatibility standards (ISO 10993 series) for biological safety. This is a material science and biocompatibility assessment, not a diagnostic accuracy assessment.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, and no training set was involved.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary

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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

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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

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
RegulationName	Denture Relining, Repairing, Or RebasingResin	Denture Relining, Repairing, Or RebasingResin
Product Code	EBI	EBI
Class	Class II	Class II
DeviceIdentification	Light-cured resin	Light-cured resin
Indications forUse	DIOnavi-Denture02 is a light-curable resinindicated for fabrication and repair of fulland partial removable dentures andbaseplates. The material is an alternative totraditional heat-curable and autopolymerizing resins. Fabrication of dentalprosthetics with DIOnavi-Denture02requires a computer-aided design andmanufacturing (CAD/CAM) system thatincludes the following components: digitaldenture base files based on a digitalimpression, a digital light processing (DLP)printer, and curing light equipment.	DIOnavi-Denture is a light-curable resinindicated for fabrication and repair of fulland partial removable dentures andbaseplates. The material is an alternative totraditional heat-curable and autopolymerizing resins. Fabrication of dentalprosthetics with DIOnavi-Denture requires acomputer-aided design and manufacturing(CAD/CAM) system that includes thefollowing components: digital denture basefiles based on a digital impression, a digitallight processing(DLP) printer, and curinglight equipment.
Chemicalcomposition	Dimethacrylate-based resins with photo-initiator, and pigments.	Dimethacrylate-based resins with photo-initiator, and pigments.
Chemicalformulation	Pre-mixed liquid resin provided in acontainer	Pre-mixed liquid resin provided in acontainer
Polymerization(Curing)Method	Visible light	Visible light
Fabrication ofDenture Base	Automated 3D printing of resin in multiplelayers, each light-cured before adding nextlayer, with post curing in light chamber	Automated 3D printing of resin in multiplelayers, each light-cured before adding nextlayer, 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)
TeethAssemble	Bonding	Bonding
Sterilization	Non-sterile	Non-sterile
Shelf-life	2 years	2 years
DeviceCharacteristics	Automated 3D printing of resin in multiplelayers, each light-cured before adding nextlayer, with post curing in light chamber.	Automated 3D printing of resin in multiplelayers, each light-cured before adding nextlayer, with post curing in light chamber.
SubstantialEquivalence	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

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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.

Regulation Number and Section

§ 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.