PrimmaArt

K231859 · Dentscare Ltda · EBG · Nov 26, 2024 · Dental

Device Facts

• Record ID: K231859
• Device Name: PrimmaArt
• Applicant: Dentscare Ltda
• Product Code: EBG · Dental
• Decision Date: Nov 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fabrication of temporary crowns, bridges, inlays, onlays and veneers; Fabrication of long-lasting temporary restorations; Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.

Device Story

PrimmaArt is a self-curing composite resin for indirect dental procedures, including temporary crowns, bridges, inlays, onlays, and veneers. The device consists of a base paste and a catalyzing paste stored in a cartridge and double-body syringe; these are automatically dispensed in a 1:1 ratio to minimize errors and air bubbles. It is intended for use by dental professionals in clinics or laboratories. The material is applied to the patient's teeth, requiring finishing and polishing after polymerization. The device provides temporary restorations, benefiting patients by protecting prepared teeth during the fabrication of permanent prosthetics. It is a non-reusable, temporary-use dental material.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4049, ISO 7491, and ISO 10477 standards. Metrics included setting time (2m48s), heat release (0.30 mW/mg), viscosity (Base: 92733 mPa.s; Catalyst: 90133 mPa.s), radiopacity (1.68 mm), flexural strength (65.5 MPa), water sorption (9.389 µg/mm³), solubility (1.542 µg/mm³), and Vickers microhardness (11.81 HV). Accelerated stability studies (225 days) showed no significant physical-chemical degradation.

Technological Characteristics

Self-curing composite resin. Supplied in cartridge/double-body syringe for 1:1 dispensing. Complies with ISO 7491 (color stability), ISO 10477 (polymer-based crown/veneering materials), ISO 4049 (restorative materials), and ISO 10993 (biocompatibility). Non-sterile, single-use. Storage temperature 5° to 25°C.

Indications for Use

Indicated for fabrication of temporary crowns, bridges, inlays, onlays, and veneers; fabrication of long-lasting temporary restorations; and rebasing of prefabricated temporary crowns (composite, polycarbonate, or metal). No specific age or gender restrictions noted.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• Structur 3 (K120779)

Reference Devices

• Llis, Vittra APS (K191306)
• Opallis, Opallis Flow (K201707)
• Allcem, Allcem Core (K183465)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, 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.

November 26, 2024

DentsCare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 2950 West Cypress Creek Rd. Ste 110 Fort Lauderdale, Florida 33309

Re: K231859

Trade/Device Name: PrimmaArt Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: September 27, 2024 Received: September 27, 2024

Dear Rodrigo Abreu:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

# MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT 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) K231859

Device Name PrimmaArt

Indications for Use (Describe)

- Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- Fabrication of long-lasting temporary restorations;
- Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------|
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------|

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Image /page/4/Picture/0 description: The image contains the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with wave-like lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).

# K231859

# Section 5

# 510(k) SUMMARY

A) Submitter's Name: DENTSCARE LTDA

Owner / Operator Registration Number: 3007210751

### Manufacture Registration Number: 3007210751

B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL

#### C) Phone and Fax Numbers

Phone: [phone]

D) Contact Person:

Roberta Uyara

Tel.: [phone]

E) Preparation Date: November 25, 2024

F) Classification Name: Crown And Bridge, Temporary, Resin

Common / Usual Name: Temporary crown and bridge resin

Proprietary Name: PrimmaArt

Product Code: EBG

Class: Class II

Regulation: 21 CFR 872.3770

### G) Device Description

Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.

### H) Substantial Equivalence (Predicates):

| Predicate<br>Type | Predicate<br>Description | 510(k) Number | Model | Company |
|-------------------|-------------------------------|---------------|------------------|-------------------|
| Predicate | Main Predicate | K120779 | Structur 3 | VOCO<br>GmbH |
| Reference | Biocompatibility<br>Reference | K191306 | Llis, Vittra APS | Dentscare<br>LTDA |

The PrimmaArt is equivalent with the following product:

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Image /page/5/Picture/0 description: The image contains the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines inside the upper part of the "D", resembling waves or airflow. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray, with the first letter capitalized.

# DENTSCARE LTDA BENTOGARE ETDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA
CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131

| Reference | Biocompatibility<br>Reference | K201707 | Opallis, Opallis Flow | Dentscare<br>LTDA |
|-----------|-------------------------------|---------|-----------------------|-------------------|
| Reference | Biocompatibility<br>Reference | K183465 | Allcem, Allcem Core | Dentscare<br>LTDA |

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Image /page/6/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, and the name 'DentsCare' written below. The contact information includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).

### I) Indications for Use Statement:

- · Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- · Fabrication of long-lasting temporary restorations;
- · Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.

| Indications for Use Comparison | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| PrimmaArt | Structur 3 |
| - Fabrication of temporary crowns, bridges, inlays, onlays and veneers; | - Fabrication of temporary crowns, bridges, inlays, onlays, partial crowns, veneers and temporary posts. |
| - Fabrication of long-lasting temporary restorations; | - Fabrication of long-term temporary restorations |
| - Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal. | - Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal. |

#### Discussion:

The products are similar. Both devices are indicated to produce temporary pieces (crowns, bridges, inlays, onlays and veneers), long-term temporary restorations and rebasing of prefabricated temporary crowns made or metal.

#### J) Technological Characteristics Comparison:

The predicate device used to establish equivalence for the PrimmaArt device is outlined below. This section of this submission will provide a comparison of dechnical specifications of the PrimmaArt to the predicate device stratified by functional modality.

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Image /page/7/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, along with the name 'DentsCare' written below. The contact information includes the address 'AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL' and the phone number 'Ph: 55 - 47 - 3441-6131'.

| Device<br>Manufacturer<br>and<br>Common Name | PrimmaArt<br>Dentscare Ltda | Structur 3<br>VOCO GmbH |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 510k # | Not assigned yet | K120779 |
| Classification | Class II | Class II |
| Regulation # | 21 CFR 872.3770 | 21 CFR 872.3770 |
| Product Code | EBG | EBG |
| Classification Name | Temporary crown and bridge resin | Temporary crown and bridge resin |
| Patient Population | All the groups | All the groups |
| Prescription Use | RX only | RX only |
| Environment | Dental prosthetics and authorized laboratories<br>and clinics.<br>PrimmaArt must be stored in temperatures<br>between 5° to 25°C. | Dental prosthetics and authorized laboratories<br>and clinics.<br>Structur 3 must be stored in temperatures<br>between 4° to 23°C |
| Applicable Standards | ISO 7491; ISO 10477; ISO 10993; ISO 4049 | ISO 7491; ISO 10477; ISO 10993; ISO 4049 |
| Device Sterilization | Not Applicable | Not Applicable |
| Primary Package Container: | Syringe and cartridge | Syringe and cartridge |
| Shelf life | 2 years | Not disclosed by the manufacturer |
| Use the same materials or<br>substances in contact with<br>the same human tissues<br>or body fluids? | YES | YES |
| Is the product in compliance<br>to EN ISO 10993? | YES | YES |
| Tissues | Enamel and Dentin | Enamel and Dentin |
| Reusable | NO | NO |
| Duration | Temporary | Temporary |
| Part of body | Oral, teeth | Oral, teeth |
| it<br>used<br>for<br>the<br>ls<br>same<br>clinical condition? | yes | yes |
| Is it used at the same site in the body? | yes | yes |
| Is it used in a similar population? | yes | yes |
| Is it used for the same intended purpose? | yes | yes |
| Is not foreseen to deliver significantly different performances? | no | no |
| Is it similar conditions of use? | yes | yes |
| Is it similar specifications and properties | yes | yes |
| Is it similar principles of operation? | yes | yes |
| CLINICAL STEP | PrimmaArt (Dentscare) | Structur 3 (VOCO) |
| Two options: total isolation or<br>relative isolation | YES | YES |
| Application<br>according<br>to<br>adhesive technique | YES | YES |
| Require<br>finishing<br>and<br>polishing | YES | YES |

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Image /page/8/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter D with horizontal lines inside it, above the word "DentsCare" in a sans-serif font. The text "Dents" is also visible, but it is unclear what it refers to.

| Specification | PrimmaArt | Structur 3 |
|----------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------|
| Shade consistency and color<br>stability ISO 4049 e 7491 | No more than a small color change | Not performed. Not disclosed by the<br>manufacturer. |
| Setting time and heat<br>released<br>ISO 4049 | Setting time: 2m48s<br>Heat released: 0.30 mW/mg | Setting time: 3m02s<br>Heat released: 0.31 mW/mg |
| Viscosity | Base Paste: 92733 mPa.s<br>Catalyst paste: 90133 mPa.s | Not disclosed by the manufacturer |
| Surface Finish ISO 10477 | According to ISO 10477, the polymerized | Not disclosed by the manufacturer |

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Image /page/9/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with three horizontal lines inside. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.

| | composite has a shiny surface | |
|-------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------|
| Radio-opacity ISO 4049 | 1.68 mm | < 1 |
| Flexing Resistance ISO 10477 | 65.5 MPa | 68.0 MPa |
| Water sorption and solubility<br>ISO 4049 | Sorption: 9.389 ± 1.26 µg/mm³<br>Solubility: 1.542 ± 0.32 µg/mm³ | Sorption: 10.527 ± 1.29 µg/mm³<br>Solubility: 2.016 ± 0.31 µg/mm³ |
| Working time | More than 60 seconds | Not disclosed by the manufacturer |
| Microhardness Vickers | 11,81 HV | 4,55 HV |

#### Discussion:

The subject device is similar to the predicate device in that they are light activated, usar self-curing, restorative composite, permanently cementing restorations of temporary pieces for indirect dental procedures. The subject device and the predicate device have substantially equivalent of indications for use, technological properties and fulfil the ISO 7491 e ISO 10477 ISO 4049 minimum requirements. Despite the minor differences in formulation between the predicate, they can be considered equivalent, since tifferences does not affect the products laboratorial and clinical performance and safety.

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Image /page/10/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" with three horizontal lines emanating from the top left corner, suggesting movement or airflow. Below the symbol, the word "DentsCare" is written in a clean, sans-serif font, with the "D" in a slightly larger size and a darker shade of gray compared to the rest of the word.

DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131

## K)Applicable Standards:

In order to reach substantially equivalent to the predicate device PrimmaArt was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry.

ISO 7491:2000 – Dental materials – Determination of colour stability

ISO 10477:2018 – Dentistry – Polymer-based crown and veneering materials

ISO 4049:2009 - Dentistry - Polymer - based, restorative materials

ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (EN ISO 10993-1:2009)

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Image /page/11/Picture/0 description: The image shows a logo for a company called DentsCare. The logo features a stylized letter "D" with horizontal lines emanating from it, suggesting movement or flow. Next to the logo is the text "DentsCare" in a clear, sans-serif font.

DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131

# L) Non-clinical Testing:

In order to study the performance of the product, pre-clinical tests were performed according to the table below.

| Test | Specification | Results |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Setting<br>time<br>and<br>heat<br>released | According to EN ISO 4049, for<br>self curing restorative<br>materials, the setting time<br>shall be no more than 5<br>minutes.<br><br>The time considered for the<br>project is 2\'30\" and 3\'10\" and<br>the heat released less than<br>0,60mW/mg. | Product was evaluated using the<br>Differential Scanning Calorimetry<br>Test (DSC) and presented results<br>according to the design input. |
| Viscosity | According to the design input<br>the viscosity of the base and<br>the catalyzer should be<br>between 60000 and 100000<br>mPa.s. | The test was done using the<br>Brooksfield digital viscosimeter and<br>the results were within the defined<br>limits. |
| Surface Finish | According to the ISO 10477<br>standard, the specification for<br>finishing of a surface is that<br>the polymerised composite<br>presents a reflective surface. | It was observed that the surface of<br>the specimen was reflective, so this<br>material is considered to be in<br>accordance with the specifications<br>of the ISO 10477 standard. |
| Shade<br>consistency<br>and<br>color<br>stability | According to EN ISO 4049 and<br>ISO 7491, acceptance must be<br>made as long as there is no<br>more than a small color<br>change. | Only a small color difference<br>(acceptable according to ISO 4049)<br>was attested, when comparing<br>Sample 3 (color A3) with Bisacrilic<br>Technical Profile FGM. In the other<br>analyzes, no changes were<br>identified. |
| Radiopacity | According to ISO 4049, the<br>material<br>is<br>considered<br>radiopaque if the specimen has<br>a value of > 1.0 mm, when<br>compared to the aluminum<br>scale, therefore, the value of<br>"X" obtained through the<br>equation of the line, must be ><br>1. | The FGM Bisacrylic resin, presented<br>results above that specified by ISO<br>4049. |
| Flexing<br>Resistance | According to ISO 10477, the<br>specified<br>flexural strength is<br>≥50MPa. | The FGM Bisacrylic<br>type<br>resin<br>presented all the results within the<br>values specified in the ISO<br>10477 standard,<br>therefore,<br>the<br>material<br>meets<br>the<br>requirements<br>determined<br>in |
| | | terms of 3-point Flexural Strength. |
| Water sorption<br>and solubility | According to ISO 4049, the<br>specified for sorption is a<br>maximum of 40 µg/mm³ and<br>for solubility a maximum of 7.5<br>µg/mm³. | All results below are within the<br>specified limit, therefore the<br>material is considered to conform. |
| Working time | According to EN ISO 4049, the<br>working time for cementation<br>materials must be at least 60<br>seconds. | The results show that the product<br>has a working time of more than<br>60 seconds. |
| Accelerated<br>Stability<br>Studies | Study created to accelerate the<br>possible chemical degradation<br>and/or physical changes of the<br>product in forced conditions of<br>storage. | The FGM Bisacrylic Resin product<br>did not show significant changes in<br>terms of its physical-chemical<br>properties during the accelerated<br>stability process (225 days). |
| Evaluation<br>of<br>Report<br>Long-Term<br>Stability<br>(Shelf) | Study designed to verify the<br>physical and chemical<br>characteristics of the product<br>during the expected shelf life.<br>The results are used to confirm<br>the expiration date and storage<br>conditions. | We don't have any conclusive data<br>about shelf life yet. At the moment<br>we are using the estimated shelf<br>life in 2 years in the storage<br>condition of 25°C, based on no<br>accelerated stability test. |
| Michohardness<br>Vickers | According to the Project Entry<br>Requirements, the Hardness<br>(HV) must be between 5 and<br>15 HV, and in the same way,<br>the results must be similar or<br>superior (justified) when<br>compared to the competitor<br>under study. | All results are within the specified<br>limit, so the material is considered<br>as conform. |

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Image /page/12/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color, with three horizontal lines emanating from the left side of the "D", suggesting movement or flow. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in the same muted blue-gray color, completing the branding for the dental care company.

Conclusion: Based on the performance test applied to this PrimmaArt and the predicate comparison (Structur 3), we conclude that the device in question is substantially equivalent with the predicate, as all products meet the same recognized standards.