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 based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.

Device Description

DIOnavi-Denture 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 a 510(k) summary for the DIOnavi-Denture, a light-curable resin used for fabricating and repairing dentures. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through a clinical study. Therefore, several of the requested categories for acceptance criteria and study details are not directly applicable or available in this M.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to adherence to international standards and internal testing to demonstrate substantial equivalence, rather than defining specific clinical acceptance criteria for performance measures like diagnostic accuracy. The "acceptance criteria" are implied by meeting the requirements of the standards for similar devices.

Acceptance Criteria (Implied by Standards)	Reported Device Performance (as per ISO 20795-1)
Visual Inspection (meets standard)	Results met criteria of the standard
Capacity (meets standard)	Results met criteria of the standard
Package Integrity (meets standard)	Results met criteria of the standard
Dimensions (meets standard)	Results met criteria of the standard
Surface Characteristics (meets standard)	Results met criteria of the standard
Shape Capability (meets standard)	Results met criteria of the standard
Translucency (meets standard)	Results met criteria of the standard
Color Stability (meets standard)	Results met criteria of the standard
Flexural Strength (after curing > 65 MPa as per predicate/reference)	DIOnavi-Denture: 65 < X (implies > 65 MPa)
Density (within range of predicate/reference e.g., 1.05-1.3)	DIOnavi-Denture: 1.11-1.3
Viscosity (within range of predicate/reference e.g., 770-2000 cPs)	DIOnavi-Denture: 770-1430 cPs
Biocompatibility (meets ISO 10993-1 requirements)	Cytotoxicity, Sensitization, Irritation reactivity, Genotoxicity, Sub-acute toxicity, Material-mediated pyrogenicity tests all addressed and met standards.
Shelf-life (2 years)	Shelf-life testing conducted with bench tests from ISO 20975-1, device has 2 years shelf-life.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not detail specific sample sizes for non-clinical performance tests. The testing was laboratory-based, not clinical, so direct provenance like "country of origin" or "retrospective/prospective" data in a clinical sense is not applicable. The tests performed were outlined to meet ISO standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This was a non-clinical, bench-testing study of material properties, not a study involving expert assessment or ground truth establishment based on human interpretation.

4. Adjudication Method for the Test Set

Not applicable. There was no element of human judgment or interpretation requiring adjudication.

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

Not applicable. The DIOnavi-Denture is a tangible dental material and not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device. The product is a resin for dental fabrication.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing was defined by the established criteria and physical/chemical measurement techniques specified in the relevant ISO standards (ISO 20795-1 for dental base polymers and ISO 10993 for biocompatibility). For example, flexural strength is measured directly rather than requiring expert consensus.

8. The Sample Size for the Training Set

Not applicable. This is a physical material, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 22, 2020

DIO Corporation % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc 1150 Roosevelt, STE 200 Irvine, California 92620

Re: K193623

Trade/Device Name: DIOnavi-Denture Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: February 3, 2020 Received: February 11, 2020

Dear Priscilla Chung:

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.

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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 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 (QS) 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.

for Srinivas "Nandu" Nandkumar, Ph.D. 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) K193623

Device Name DIOnavi-Denture

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters "DIO" in a sans-serif font, with "DI" in gray and "O" in pink with a small pink circle above and to the right of it. Below the letters is the text "Implant Solution" in a smaller, gray, sans-serif font.

510(k) Summary K193623

This 510(k) Summary is being submitted in accordance with requirement of 21 CFR Part 807.92

Submitter:

Jiae, Park DIO Corporation 66 Centum seo-ro, Haeundae-gu, Busan, 48058. Republic of Korea Phone +82-51-745-7836 Fax +82-51-745-7781

Official correspondent:

Priscilla Juhee Chung LK Consulting Group USA, Inc 1150 Roosevelt, STE 200, Irvine CA 92620 Email: juhee.c@lkconsultinggroup.com Phone +1-714-702-5789 +1-714-409-3357 Fax

Device Information:

Proprietary Name: DIOnavi-Denture Common Name: Dental Denture Resin Classification Name: Denture Relining, Repairing, or Rebasing Resin Product Code: EBI Regulation Number: 21 CFR 872.3760 Device Class: Class II Date prepared: OCT 18, 2020

Description

Indication For Use

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 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 : Dentca Denture Base II (K162044) Reference Device : Nextdent Denture, E-Denture (K162572)

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Image /page/4/Picture/1 description: The image shows the logo for DIO Implant Solution. The word "DIO" is displayed in a bold, sans-serif font, with the "DI" in gray and the "O" in pink with a small pink circle above and to the right of it. Below the word "DIO" are the words "Implant Solution" in a smaller, gray, sans-serif font.

Summaries of Technological Characteristics

The following table compares technological and other characteristics of the subject and a predicate device.

	Subject Device	Primary Predicate Device	Reference Device
Applicant	DIO Corporation	Dentca, Inc.	Vertex-Dental B.V.
Trade Name	DIOnavi-Denture	Dentca Denture Base II	NextDent™ DentureE-Denture
510(K) No.	K193623	K162044	K162572
RegulationName	Denture Relining, Repairing, Or RebasingResin	Denture Relining, Repairing, Or RebasingResin	Resin, Denture, Relining, Repairing, Rebasing
Product Code	EBI	EBI	EBI
Class	Class II	Class II	Class II
DeviceIdentification	Light-cured resin	Light-cured resin	Light-Cure Resin,provided in container
Indicationsfor Use	DIOnavi-Denture is a light-curable resinindicated for fabrication and repair of full andpartial removable dentures and baseplates. Thematerial is an alternative to traditional heat-curable and auto polymerizing resins.Fabrication of dental prosthetics with DIOnavi-Denture requires a computer-aided design andmanufacturing (CAD/CAM) system thatincludes the following components: digitaldenture base files based on a digital impression,a digital light processing(DLP) printer, andcuring light equipment.	DENTCA Denture Base II is a light-curableresin indicated for fabrication and repair of fulland partial removable dentures and baseplates.The material is an alternative to traditionalheat-curable and auto polymerizing resins.Fabrication of dental prosthetics with DentcaDenture Base II requires a computer-aideddesign and manufacturing (CAD/CAM) systemthat includes the following components: digitaldenture base files based on a digital impression,stereolithographic additive printer, and curinglight equipment.	NextDent™ Denture / E-Denture is a light-cured resin indicated for the fabrication ofdenture bases fabricated in dental laboratories,including full and partial removable dentures.The material is an alternative to traditional heatcured and auto polymerization resins.NextDent™ Denture / E-Denture is intendedexclusively for professional dental work.Fabrication of denture bases with NextDent ™Denture / E-Denture requires a computer-aidedand manufacturing (CAD/CAM) system thatincludes the following; scanner, designsoftware, additive printer, and post-cure unit.NextDent™ Denture / E-Denture is compatiblewith the following CAD/CAM systemscomponents:

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Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font, with the "D" and "I" in gray and the "O" in pink with a small pink circle above and to the right of it. Below the letters, in a smaller, gray font, are the words "Implant Solution."

			Design
				Brand	Type
			Scanner	3Shape	D900
			Design software	3Shape	Dental-System 2016-Premium
			Printing:
			Printer	Brand	Type	Software
				EnvisionTEC	DDDP 4	Perfactory
				Rapidshape	D30	NetFabb
				Miicraft	125Y	MiiUtilityMiiController
				3D systems	Figure 4	3D Sprint
				Roland DG	DWP-80S	Ver1.1
			Post-Curing:
			Post-cure unit	NextDentLC-3DPrint Box
Chemicalcomposition	Dimethacrylate-based resins with photo-initiator, and pigments.	Methacrylate-based resins with photo-initiator,inhibitor and pigments	Dimethacrylate-based resins with photo-initiator, and pigments.
Chemicalformulation	Pre-mixed liquid resin provided in a container	Pre-mixed liquid resin provided in a container	Pre-mixed liquid resin provided in a container
Polymerizationn(Curing)Method	Visible light	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	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	Visible light-curing unit
Product State	Pre-mixed resin (liquid)	Pre-mixed resin (liquid)	Pre-mixed resin (liquid)
TeethAssemble	Bonding	Bonding	Bonding
Sterilization	Non-sterile	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.	Denture Base Resins, Photo-Cured productfamily comprises a family of dimethacrylateresins. In general, the products in this familyare composed of a 2-component dimethacrylicsystem, polymerized via photo initiators in a

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Image /page/6/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters "DIO" in a bold sans-serif font, with "DI" in gray and "O" in pink. Above the "O" is a small pink circle. Below the letters is the text "Implant Solution" in a smaller, sans-serif font.

			3D printer setting. The color of the denture isdetermined by the addition of pigments.
Physicalproperties	Density: 1.11-1.3Viscosity : 770-1430 cPsFlexural strength (After curing): 65<X	Density: 1.05<X<1.20Viscosity: 1000-2000 cPsFlexural strength (After curing): 65<X	Density: 1.26Viscosity: 800-1500 cPsFlexural strength (After curing): 65<X
SubstantialEquivalenceDiscussion	The indications for use and the technological characteristics are the same between the subject device and the predicate device. The subject device andthe predicate device use similar technologies to make the final dentures and base plates except the type of printer used. The subject device usesdigital light processing(DLP) printer instead of a stereolithography(SLA) additive printer.The physical properties and the steps in the process are also similar. The indications for Use Statement are the same except the reference to acompatible printer type. The major difference is that the subject device is a Dimethacrylate-based resin and the primary predicate device is aMethacrylate-based resin, and they use a different type of a printer. To address this difference in substantial equivalence, we selected NextDent™Denture/E-Denture(K162572) as the reference device which is the same type of Dimethacrylate-based resin. There might be differences informulation, however, we have performed biocompatibility tests in accordance with ISO 10993 and performance tests in accordance with ISO20795-1. All of the test results met the criteria and demonstrated that this difference would not raise a question in substantial equivalence and thesubject device would perform as well as the predicate devices. Based on the information submitted herein, we conclude that the subject device issubstantially equivalent to the predicate device.

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Image /page/7/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DI" is in gray, while the "O" is in pink with a small pink circle above and to the right of it. Below the letters, in a smaller font, are the words "Implant Solution" in gray.

Non-clinical Testing

Performance tests in accordance with ISO 20795-1 including visual inspection, capacity, package integrity, dimensions, surface characteristics, shape capability, translucency, color stability, flexural strength 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 20975-1.

Biocompatibility

Biocompatibility Tests in accordance with FDA Guidance Document Use of International ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

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-Denture 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.