(158 days)
Not Found
No
The summary describes a 3D printing material and the required CAD/CAM system, but there is no mention of AI or ML being used in the design, printing, or post-processing steps. The performance studies are standard bench and biocompatibility tests for dental materials.
No
The device is a material used for fabricating denture bases, which are prosthetic devices, not therapeutic devices themselves.
No
The device is a light-cured resin intended for the fabrication of denture bases, which is a manufacturing process, not a diagnostic one.
No
The device is a light-cured resin material used in a 3D printing process to fabricate denture bases. It is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of denture bases, which are prosthetic devices used in the mouth.
- Device Description: It's a light-cured resin used in a 3D printer to create a physical object (a denture base).
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to create a product that will be used in vivo (inside the body).
N/A
Intended Use / 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.
Product codes
EBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional dental work / dental laboratories
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
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.
Key Metrics
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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 | ||
| Number | 21 CFR 872.3760 | 21 CFR 872.3760 |
| Device | ||
| Classification | ||
| Name/Device Common | ||
| Name | Denture Relining, Repairing or Rebasing | |
| Resin | Denture Relining, Repairing or | |
| Rebasing Resin | ||
| Product | ||
| Code | EBI | EBI |
| Classification | II | II |
| 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. | NextDent Denture/E-Denture 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. NextDent Denture/E-Denture is | ||
| intended exclusively for professional | ||
| dental work. Fabrication of denture | ||
| bases with NextDent Denture/E- | ||
| Denture requires a computer-aided | ||
| and manufacturing (CAD/CAM) system | ||
| that includes the following: scanner, | ||
| design software, additive printer and | ||
| post-cure unit. | ||
| 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 | ||
| printing, the printed product is placed in | ||
| a UV-light curing box for final | ||
| polymerization. | ||
| 3D printer is not included with the | ||
| device. | NextDent Denture/E-Denture 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 printing, the printed | ||
| product is placed in a UV-light curing | ||
| box for final polymerization. | ||
| 3D printer is not included with the | ||
| device. | ||
| Material | Dimethacrylate resins | Dimethacrylate resins |
| Material | ||
| Properties | Meets ISO 20795-1 for a Type 4 | |
| Material. | Meets ISO 20795-1 for a Type 4 | |
| material except for water solubility | ||
| 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.