DIOnavi-Denture

K193623 · Dio Corporation · EBI · Oct 22, 2020 · Dental

Device Facts

• Record ID: K193623
• Device Name: DIOnavi-Denture
• Applicant: Dio Corporation
• Product Code: EBI · Dental
• Decision Date: Oct 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

DIOnavi-Denture is a dimethacrylate-based, light-curable resin used for additive manufacturing of dental prosthetics. The process begins with a digital impression of the patient's oral region, followed by CAD design of the denture base. The device is processed in a DLP (digital light processing) 3D printer, which builds the denture layer-by-layer. After printing, the device undergoes final polymerization in a UV-light curing box. The finished denture is then fitted to the patient by a dental professional. The device is intended for use in dental laboratories to create custom prosthetics, serving as an alternative to traditional heat-curable or auto-polymerizing resins. It benefits patients by enabling the production of custom-fit removable dentures via digital workflows.

Clinical Evidence

No clinical data. Bench testing only. Performance testing conducted per ISO 20795-1, including flexural strength, color stability, and translucency. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, irritation, genotoxicity, sub-acute toxicity, and material-mediated pyrogenicity.

Technological Characteristics

Dimethacrylate-based resin with photo-initiators and pigments. Non-sterile, liquid state. Polymerization via visible light (DLP printing and UV-light curing). Shelf life: 2 years. Complies with ISO 20795-1 (performance) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for fabrication and repair of full and partial removable dentures and baseplates in patients requiring dental prosthetics.

Regulatory Classification

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.

Predicate Devices

• Dentca Denture Base II (K162044)

Reference Devices

• Nextdent Denture, E-Denture (K162572)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 [phone] Fax [phone]

## Official correspondent:

Priscilla Juhee Chung LK Consulting Group USA, Inc 1150 Roosevelt, STE 200, Irvine CA 92620 Email: [e-mail] Phone [phone] [phone] 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

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.

#### 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™ Denture<br>E-Denture |
| 510(K) No. | K193623 | K162044 | K162572 |
| Regulation<br>Name | Denture Relining, Repairing, Or Rebasing<br>Resin | Denture Relining, Repairing, Or Rebasing<br>Resin | Resin, Denture, Relining, Repairing, Rebasing |
| Product Code | EBI | EBI | EBI |
| Class | Class II | Class II | Class II |
| Device<br>Identification | Light-cured resin | Light-cured resin | Light-Cure Resin,<br>provided in container |
| Indications<br>for Use | DIOnavi-Denture is a light-curable resin<br>indicated for fabrication and repair of full and<br>partial removable dentures and baseplates. The<br>material is an alternative to traditional heat-<br>curable and auto polymerizing resins.<br>Fabrication of dental prosthetics with DIOnavi-<br>Denture requires a computer-aided design and<br>manufacturing (CAD/CAM) system that<br>includes the following components: digital<br>denture base files based on a digital impression,<br>a digital light processing(DLP) printer, and<br>curing light equipment. | DENTCA Denture Base II is a light-curable<br>resin indicated for fabrication and repair of full<br>and partial removable dentures and baseplates.<br>The material is an alternative to traditional<br>heat-curable and auto polymerizing resins.<br>Fabrication of dental prosthetics with Dentca<br>Denture Base II requires a computer-aided<br>design and manufacturing (CAD/CAM) system<br>that includes the following components: digital<br>denture base files based on a digital impression,<br>stereolithographic additive printer, and curing<br>light equipment. | NextDent™ Denture / E-Denture is a light-<br>cured resin indicated for the fabrication of<br>denture bases fabricated in dental laboratories,<br>including full and partial removable dentures.<br>The material is an alternative to traditional heat<br>cured and auto polymerization resins.<br>NextDent™ Denture / E-Denture is intended<br>exclusively for professional dental work.<br>Fabrication of denture bases with NextDent ™<br>Denture / E-Denture requires a computer-aided<br>and manufacturing (CAD/CAM) system that<br>includes the following; scanner, design<br>software, additive printer, and post-cure unit.<br>NextDent™ Denture / E-Denture is compatible<br>with the following CAD/CAM systems<br>components: |

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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 | MiiUtility<br>MiiController |
| | | | | | 3D systems | Figure 4 | 3D Sprint |
| | | | | | Roland DG | DWP-80S | Ver1.1 |
| | | | Post-Curing: | | | | |
| | | | Post-cure unit | | NextDent<br>LC-3DPrint Box | | |
| Chemical<br>composition | Dimethacrylate-based resins with photo-<br>initiator, and pigments. | Methacrylate-based resins with photo-initiator,<br>inhibitor and pigments | Dimethacrylate-based resins with photo-<br>initiator, and pigments. | | | | |
| Chemical<br>formulation | Pre-mixed liquid resin provided in a container | Pre-mixed liquid resin provided in a container | Pre-mixed liquid resin provided in a container | | | | |
| Polymerization<br>n<br>(Curing)<br>Method | Visible light | Visible light | Visible light | | | | |
| Fabrication of<br>Denture Base | Automated 3D printing of resin in multiple<br>layers, each light-cured before adding next<br>layer, with post curing in light chamber | Automated 3D printing of resin in multiple<br>layers, each light-cured before adding next<br>layer, with post curing in light chamber | Automated 3D printing of resin in multiple<br>layers, each light-cured before adding next<br>layer, 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) | | | | |
| Teeth<br>Assemble | Bonding | Bonding | Bonding | | | | |
| Sterilization | Non-sterile | Non-sterile | Non-sterile | | | | |
| Shelf-life | 2 years | - | 2 years | | | | |
| Device<br>Characteristics | Automated 3D printing of resin in multiple<br>layers, each light-cured before adding next<br>layer, with post curing in light chamber. | Automated 3D printing of resin in multiple<br>layers, each light-cured before adding next<br>layer, with post curing in light chamber. | Denture Base Resins, Photo-Cured product<br>family comprises a family of dimethacrylate<br>resins. In general, the products in this family<br>are composed of a 2-component dimethacrylic<br>system, 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 is<br>determined by the addition of pigments. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Physical<br>properties | Density: 1.11-1.3<br>Viscosity : 770-1430 cPs<br>Flexural strength (After curing): 65<X | Density: 1.05<X<1.20<br>Viscosity: 1000-2000 cPs<br>Flexural strength (After curing): 65<X | Density: 1.26<br>Viscosity: 800-1500 cPs<br>Flexural strength (After curing): 65<X |
| Substantial<br>Equivalence<br>Discussion | The indications for use and the technological characteristics are the same between the subject device and the predicate device. The subject device and<br>the predicate device use similar technologies to make the final dentures and base plates except the type of printer used. The subject device uses<br>digital light processing(DLP) printer instead of a stereolithography(SLA) additive printer.<br>The physical properties and the steps in the process are also similar. The indications for Use Statement are the same except the reference to a<br>compatible printer type. The major difference is that the subject device is a Dimethacrylate-based resin and the primary predicate device is a<br>Methacrylate-based resin, and they use a different type of a printer. To address this difference in substantial equivalence, we selected NextDent™<br>Denture/E-Denture(K162572) as the reference device which is the same type of Dimethacrylate-based resin. There might be differences in<br>formulation, however, we have performed biocompatibility tests in accordance with ISO 10993 and performance tests in accordance with ISO<br>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<br>subject device would perform as well as the predicate devices. Based on the information submitted herein, we conclude that the subject device is<br>substantially 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.