Juell 3D Volo Base

K181220 · Park Dental Research Corporation · EBI · Oct 12, 2018 · Dental

Device Facts

• Record ID: K181220
• Device Name: Juell 3D Volo Base
• Applicant: Park Dental Research Corporation
• Product Code: EBI · Dental
• Decision Date: Oct 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Juell 3D Volo Base is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. Juell 3D Volo Base is intended exclusively for professional dental work. Fabrication of denture bases with Juell 3D Volo Base requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unit.

Device Story

Juell 3D Volo Base is a light-cured dimethacrylate resin for 3D-printing denture bases. Input is a 3D stereolithographic drawing generated via CAD/CAM software (e.g., Dental Wings DWOS). The material is processed in a DLP 3D printer (e.g., Juell 3D) and finalized in a UV-light post-cure unit (e.g., Juell 3D Cure Cube 360). Used exclusively in dental laboratories by professionals. Output is a custom-fit denture base. Benefits include an alternative to traditional heat-cured or auto-polymerization resins for removable prosthetics.

Clinical Evidence

Bench testing only. Compliance with ISO 20795-1 Type 4 material standards was verified for flexural strength, flexural modulus, water solubility, and residual monomer. No clinical data provided.

Technological Characteristics

Dimethacrylate resin mixture with photoinitiator and pigments. Form factor: liquid resin for additive manufacturing. Energy source: UV light for polymerization. Compatible with DLP 3D printers and UV post-cure units. Complies with ISO 20795-1 Type 4 material standards.

Indications for Use

Indicated for fabrication of full and partial removable denture bases in dental laboratories by dental professionals. Requires CAD/CAM system (scanner, design software, additive printer, post-cure unit).

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

• NextDent Denture/E-Denture (K162572)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 12, 2018

Park Dental Research Corporation % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030

Re: K181220

Trade/Device Name: Juell 3D Volo Base Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: July 3, 2018 Received: July 16, 2018

Dear Angela Blackwell:

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 mav, 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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mary S. Runner -S3

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K181220

Device Name Juell 3D Volo Base

#### Indications for Use (Describe)

Juell 3D Volo Base is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. Juell 3D Volo Base is intended exclusively for professional dental work. Fabrication of denture bases with Juell 3D Volo Base requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unit.

Juell 3D Volo Base is compatible with the following CAD/CAM systems components:

| Design | Brand | Type | |
|-----------------|--------------|---------------|----------|
| Scanner | Dental Wings | I series | |
| Design Software | Dental Wings | DWOS | |
| Printing | Brand | Type | Software |
| Printer | Juell 3D | DLP | Flash OC |
| Post-Curing | Brand | Type | |
| Post-Cure Unit | Juell 3D | Cure Cube 360 | |

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 K181220

## October 3, 2018

Park Dental Research Corporation

2401 N. Commerce St. Suite E Ardmore, OK 73401

## 800-243-7372

Contact Person: Dr. Ronald A Bulard

Trade Name: Juell 3D Volo Base

Common Name: Denture Base

Product Code: EBI

Regulation No.: 872.3760 Denture Relining, Repairing or Rebasing Resin

Classification: Class II

Predicate 510k: K162572 NextDent Denture/E-Denture from Vertex-Dental BV

## Device Description:

Juell 3D Volo Base 3D-printing material is a light-cured resin indicated for the manufacturing of denture bases. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printed product is placed in a UV-light curing box for final polymerization.

3D printer is not included with the device.

## Indications for Use:

Juell 3D Volo Base is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. Juell 3D Volo Base is intended exclusively for professional dental work. Fabrication of denture bases with Juell 3D Volo Base requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unit.

Juell 3D Volo Base is compatible with the following CAD/CAM systems components:

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| Design | | | |
|-----------------|--------------|---------------|----------|
| | Brand | Type | |
| Scanner | Dental Wings | l series | |
| Design Software | Dental Wings | DWOS | |
| Printing | | | |
| | Brand | Type | Software |
| Printer | Juell 3D | DLP | Flash OC |
| Post-Curing | | | |
| | Brand | Type | |
| Post-Cure Unit | Juell 3D | Cure Cube 360 | |

# Technological Characteristics:

Both Volo Base and NextDent Denture are mixtures of dimethacrylate resins with photoinitiator and pigments. The way they are used to make dentures is identical, using 3 D printers to form the dentures and UV light boxes for curing.

The results of this comparison demonstrate that the design, technology, materials, and composition of Juell 3D Volo Base are substantially equivalent to the predicate devices.

# Mechanism of Action:

The mechanism of action is the same as the predicate devices and supports a determination of substantial equivalence. Dentures are used the same way by the patient no matter how they are formed. All types of denture are checked the same way for fit and the concerns regarding non-cured resin are the same no matter the type of curing.

# Bench Testing:

Juell 3D Volo Base was tested for compliance with ISO 20795-1 Type 4 Material by testing the following: Flexural Strength, Flexural Modulus, Water Solubility, and Residual Monomer. All test were passed. These same tests were passed by the predicate device except for water sorption which exceeded the value for Type 4 but passed for Type 2.

## Biocompatibility Testing:

The constituents of Juell 3D Volo Base are very similar to the predicate device, NextDent Denture/E-Denture. This fact along with the very low level of residual monomer in the cured product meant no biocompatibility testing was done.

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Predicate Device Comparison Table

| | Juell 3D Volo Base | NextDent Denture/E-Denture |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Number | 21 CFR 872.3760 | 21 CFR 872.3760 |
| Device<br>Classification<br>Name/Device Common<br>Name | Denture Relining, Repairing or Rebasing<br>Resin | Denture Relining, Repairing or<br>Rebasing Resin |
| Product<br>Code | EBI | EBI |
| Classification | II | II |
| Indications<br>for use | Juell 3D Volo Base is a light-cured resin<br>indicated for the fabrication of denture<br>bases fabricated in dental laboratories,<br>including full and partial removable<br>dentures. The material is an alternative<br>to traditional heat cured and auto<br>polymerization resins. Juell 3D Volo<br>Base is intended exclusively for<br>professional dental work. Fabrication of<br>denture bases with Juell 3D Volo Base<br>requires a computer-aided and<br>manufacturing (CAD/CAM) system that<br>includes the following: scanner, design<br>software, additive printer and post-cure<br>unit. | NextDent Denture/E-Denture is a light-<br>cured resin indicated for the<br>fabrication of denture bases fabricated<br>in dental laboratories, including full<br>and partial removable dentures. The<br>material is an alternative to traditional<br>heat cured and auto polymerization<br>resins. NextDent Denture/E-Denture is<br>intended exclusively for professional<br>dental work. Fabrication of denture<br>bases with NextDent Denture/E-<br>Denture requires a computer-aided<br>and manufacturing (CAD/CAM) system<br>that includes the following: scanner,<br>design software, additive printer and<br>post-cure unit. |
| Device<br>Description | Juell 3D Volo Base 3D-printing material<br>is a light-cured resin indicated for the<br>manufacturing of denture bases. The<br>material is used in a 3D printer, which<br>prints the shape determined by a 3D<br>stereolithographic drawing. After<br>printing, the printed product is placed in<br>a UV-light curing box for final<br>polymerization.<br>3D printer is not included with the<br>device. | NextDent Denture/E-Denture 3D-<br>printing material is a light-cured resin<br>indicated for the manufacturing of<br>denture bases. The material is used in<br>a 3D printer, which prints the shape<br>determined by a 3D stereolithographic<br>drawing. After printing, the printed<br>product is placed in a UV-light curing<br>box for final polymerization.<br>3D printer is not included with the<br>device. |
| Material | Dimethacrylate resins | Dimethacrylate resins |
| Material<br>Properties | Meets ISO 20795-1 for a Type 4<br>Material. | Meets ISO 20795-1 for a Type 4<br>material except for water solubility<br>which meets the Type 2 criteria. |

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# Conclusion:

Juell 3D Volo Base has the same Indications for Use and Device Description as the identified predicate device. Volo Base is as safe, as effective, and is substantially equivalent to the predicate device in regards to design, technological characteristics, mechanism of action, materials, performance test and biocompatibility.