(392 days)
Not Found
No
The description focuses on the material composition and physical properties of a dental composite, with no mention of AI or ML capabilities. The "APS" system is described as a chemical photoinitiator system, not an AI/ML algorithm.
Yes.
The device is a restorative material used for various dental treatments like fillings, sealants, and repairs, directly addressing medical conditions and restoring physiological function.
No
The device is a light-curing composite used for dental restorations and repairs, which are treatment procedures rather than diagnostic ones.
No
The device description clearly states it is a "light-curing composite of low viscosity" with "inorganic filler content," indicating 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 uses listed are all related to direct dental restorations and repairs within the oral cavity. These are clinical procedures performed directly on the patient's teeth.
- Device Description: The device is described as a light-curing composite material used for filling cavities and making repairs. This is a material used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze biological samples. This device is clearly intended for direct application and use in vivo within the patient's mouth.
N/A
Intended Use / Indications for Use
- Base under direct restorations;
- Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy;
- Pit and fissure sealant;
- Tunnel-type preparation;
- Repair of small enamel defects;
- Bonding of tooth fragments;
- Composite resin repairs;
- Non-carious cervical lesions.
Product codes
EBF, EBC
Device Description
Vittra APS Unique Flow is a light-curing composite of low viscosity, with a single shade for all dental shades, suitable for minimally invasive cavity preparations, base/liner and minor repairs. The composite is radiopaque, with a total inorganic filler content of 58% to 62% by weight (56% to 60% by volume) and an average particle size between 1.7 and 1.9 micrometers. It does not contain Bis-GMA or Bis-EMA in its formulation, following the current trend of Bisphenol A (BPA) free products. The composite has the APS as a photoinitiator system, an acronym for Advanced Polymerization System, which consists of a combination of different photoinitiators that interact with each other, amplifying the curing capacity of the light emitted by the light-curing units. Added to different materials, the system provides several advantages. APS confers great polymerization power, which allows a greater degree of conversion, obtaining superior stability to ambient light and providing longer working time during restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, teeth
Indicated Patient Age Range
All the groups
Intended User / Care Setting
Dental prosthetics and authorized laboratories and clinics.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- Color stability: The results presented prove that the Vittra APS Unique Flow FGM resin is according to the product entry requirements, in accordance with the values specified in the ISO4049 standard.
- Flexural resistance: The results presented prove that the FGM Vittra APS Unique Flow resin is according to the product's entry requirements, being in accordance with the values specified in the ISO4049 standard for 3-point flexural strength. Flexural strength is 123.8 MPa.
- Mimicry: The results demonstrated that the product meets the specified in the entry requirements regarding mimicry, based on the acceptance criterion mentioned in the ISO 7491 standard and in item 5.3 of the ISO 4049 standard, when shade equivalence is evaluated.
- Light Passage: Can conclude that the syringe is according the basic requirements regarding the protection of external lighting, being able to provide shelter from light.
- Depth of Cure: The results demonstrate that the product meets the entry requirement related to the depth of cure and the values specified in ISO 4049. Depth of Cure: 3,996 mm.
- Radiopacity: Vittra APS Unique Flow FGM resin is according to entry requirement for Radiopacity, showing results above that specified by ISO 4049, so the resin can be considered radiopaque. Radiopacity: 1,825 mm.
- Sensitivity to ambient light: The results presented prove that the FGM Vittra APS Unique Flow resin meets the product entry requirements, being in accordance with the values specified in the ISO 4049 standard in terms of sensitivity to ambient lighting.
- Water sorption and solubility: The results show that the FGM Vittra APS Unique Flow product meets the entry requirement for sorption and water solubility, in accordance with ISO 4049. Sorption: 26.834 micrograms/mm³, Solubility: 1.632 micrograms/mm³.
- Accelerated Stability Studies: Based on the tests carried out and the results presented over those 274 days, we can guarantee that the Vittra APS Unique Flow product can be marketed for a period of 3 years, provided it is stored within the indicated storage temperature (maximum 30 degrees C).
- Evaluation Report of Long-Term Stability (Shelf): The analysis of Shelf Life has not yet been finalized, the product is being commercialized based on the results of accelerated stability acquired during the prototype.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2024
Dentscare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 2950 West Cypress Creek Rd. Ste 110 Fort Lauderdale, Florida 33309
Re: K232994
Trade/Device Name: Vittra APS Unique Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC Dated: August 20, 2024 Received: August 20, 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.
1
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 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-regulatory
2
assistance/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,
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
3
Indications for Use
510(k) Number (if known) K232994
Device Name Vittra APS Unique Flow
Indications for Use (Describe)
- Base under direct restorations;
- Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy;
- Pit and fissure sealant;
- Tunnel-type preparation;
- Repair of small enamel defects;
- Bonding of tooth fragments;
- Composite resin repairs;
- Non-carious cervical lesions.
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/4/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The address is AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL. The phone number is 55 - 47 - 3441-6131. The image also includes the text K232994, Section 5, and 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: +55 (47) 34416131
D) Contact Person:
Paula Cristine de Oliveira
Tel.: +55 (47) 99160-4500
- E) Preparation Date: August 27, 2024
F) Classification Name: Tooth shade resin material.
Common / Usual Name: Tooth shade resin material.
Proprietary Name: Vittra APS Unique Flow
Product Code: EBF
Secondary product code: EBC
Class: Class II
Regulation: 21 CFR 872.3690
G) Device Description
Vittra APS Unique Flow is a light-curing composite of low viscosity, with a single shade for all dental shades, suitable for minimally invasive cavity preparations, base/liner and minor repairs. The composite is radiopaque, with a total inorganic filler content of 58% to 62% by weight (56% to 60% by volume) and an average particle size between 1.7 and 1.9 micrometers. It does not contain Bis-GMA or Bis-EMA in its formulation, following the current trend of Bisphenol A (BPA) free products. The composite has the APS as a photoinitiator system, an acronym for Advanced Polymerization System, which consists of a combination of different photoinitiators that interact with each other, amplifying the curing capacity of the light emitted by the light-curing units. Added to different materials, the system provides several advantages. APS confers great polymerization power, which allows a greater degree of conversion, obtaining superior stability to ambient light and providing longer working time during restorations.
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Image /page/5/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with horizontal lines inside. The contact information includes the company's address on AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, as well as their phone number: 55 - 47 - 3441-6131.
H) Substantial Equivalence (Predicate Device):
The Vittra APS Unique Flow is equivalent with the following product:
| Equivalence | 510(k) Number | Model | Company |
|---|---|---|---|
| Predicate | K201707 | Opallis Flow | Dentscare |
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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 horizontal lines inside it, accompanied by the text 'DentsCare' in a sans-serif font. Below the logo, the address is listed as 'AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL', followed by the phone number 'Ph: 55 - 47 - 3441-6131'.
I) Intentions for Use:
| Indications for Use Comparison | |
|---|---|
| Vittra APS Unique Flow | Opallis Flow |
| - Base under direct restorations; | · Base/lining underneath direct restorations; |
| - Small, non-occlusal stress-bearing class I restorations | |
| according to minimally invasive filling therapy; | · Small, non-occlusal stress-bearing class I restorations |
| according to minimally invasive filling therapy; | |
| - Pit and fissure sealant; | · Pit and fissure sealant; |
| - Tunnel-type preparation; | · Tunnel-type preparation; |
| - Repair of small enamel defects; | · Repair of enamel defects; |
| - Bonding of tooth fragments; | · Bonding of dental fragments; |
| - Composite resin repairs; | · Repair in composite resin; |
| - Non-carious cervical lesions. | · Non-carious cervical lesions; |
| · Planning of preparation walls. |
Discussion:
The products are similar. The resin composites can be used for both permanent and deciduous teeth. Furthermore, indications for the new device are within those of the predicate.
J) Technological Characteristics Comparison:
The predicate device used to establish substantial equivale Flow device is outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Vittra APS Unique Flow to the predicate device.
| Device
Manufacturer
and
Common Name | Vittra APS Unique Flow
Dentscare Ltda | Opallis Flow
Dentscare Ltda |
|----------------------------------------------|------------------------------------------|--------------------------------|
| 510k # | Not assigned yet | K201707 |
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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. 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).
| Classification | Class II | Class II |
|---|---|---|
| Regulation # | 21 CFR 872.3690 | 21 CFR 872.3690 |
| Product Code | EBF, EBC | EBF |
| Classification Name | Tooth shade resin material | Tooth shade resin material |
| Patient Population | All the groups | All the groups |
| Prescription Use | RX only | RX only |
| Environment | Dental prosthetics and authorized laboratories | |
| and clinics. | ||
| Vittra APS Unique Flow must be stored in | ||
| temperatures between 5° to 30°C | Dental prosthetics and authorized laboratories | |
| and clinics. | ||
| Opallis Flow must be stored in temperatures | ||
| between 5° to 30°C | ||
| Applicable Standards | ISO 7491; ISO 10993 | ISO 7491; ISO 10993 |
| Device Sterilization | Not Applicable | Not Applicable |
| Primary Package Container: | Syringe and capsule | Syringe and capsule |
| Shelf life | 3 years | 3 years |
| Use the same materials or | ||
| substances in contact with | ||
| the same human tissues | ||
| or body fluids? | YES | YES |
| Is the product in compliance | ||
| to EN ISO 10993? | YES | YES |
| Tissues | Enamel and Dentin | Enamel and Dentin |
| Reusable | NO | NO |
| Duration | Permanent | Permanent |
| Part of body | Oral, teeth | Oral, teeth |
| Is it used for the same | ||
| clinical condition? | yes | yes |
| Is it used at the same site in | ||
| the body? | yes | yes |
| Is it used in a similar | yes | yes |
| population? | ||
| 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 | Vittra APS Unique Flow (Dentscare) | Opallis Flow (Dentscare) |
| Two options: total isolation or | ||
| relative isolation | YES | YES |
| according | ||
| Application | ||
| to | ||
| adhesive technique | YES | YES |
| Size for increments | 1.5 mm | 1.5 mm |
| Light curing unit | Power: ≥ 450mW/cm² | |
| Wavelength: 400-500nm | Power: ≥ 450mW/cm² | |
| Wavelength: 400-500nm | ||
| Require | ||
| finishing | ||
| and | ||
| polishing | YES | YES |
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Image /page/8/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 company's address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and their phone number: Ph: 55 - 47 - 3441-6131.
| Specification | Vittra APS Unique Flow (Dentscare) | Opallis Flow (Dentscare) |
|---|---|---|
| Color stability | The observers did not attest any difference of color | The observers did not attest any difference of color |
| Flexural resistance | 123.8 MPa | 137.80 MPa |
| Mimicry | The observers did not attest any difference of color | - |
| Light Passage | The applicator is according to the basic | |
| requirements regarding the protection of external | ||
| lighting, being able to provide shelter from light. | - | |
| Depth of Cure | 3,996 mm | Opaque shades: 2.97 mm |
| Non-opaque shades: 3.01 mm | ||
| Radiopacity | 1,825 mm | 2.49 mm |
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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 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).
| Sensitivity to ambient light | physically homogeneous | physically homogeneous |
|---|---|---|
| Water sorption and solubility | Sorption: 26.834 µg/mm³ | |
| Solubility: 1.632 µg/mm³ | Sorption: 27.92 µg/mm³ | |
| Solubility: 5.46 µg/mm³ | ||
| Compressive Strength (MPa) | 338.2 MPa | 339.9 MPa |
| Elastic Modulus (MPa) | 5854 MPa | 6836 MPa |
| Intensity for curing (mW/cm²) | >450 mW/cm² | >450 mW/cm² |
| Wavelength for curing (nm) | 400-500 nm | 400-500 nm |
| Filler particle size | ||
| distribuition (µm) | Flexural strength is 123.8 MPa. | |
| Light Passage | Stage 1 - The syringe must not | |
| allow light to pass through its | ||
| components when radiation is | ||
| applied by LED curing light. | ||
| Stage 2 and 3 - The resin must be | ||
| removed from the stored location | ||
| (tube or cap), analyzed sensorially, | ||
| and show no difference regarding | ||
| homogeneity, consistency and | ||
| applicability, when compared to | ||
| resin without exposure to radiation. | Can conclude that the syringe is | |
| according the basic requirements | ||
| regarding the protection of external | ||
| lighting, being able to provide shelter | ||
| from light. | ||
| Depth of Cure | According to ISO 4049, the | |
| specified for this material is that its | ||
| curing depth is: > 1.5 mm. | The results demonstrate that the | |
| product meets the entry requirement | ||
| related to the depth of cure and the | ||
| values specified in ISO 4049. | ||
| Depth of Cure: 3,996 mm. | ||
| Radiopacity | According to ISO 4049, the material is | |
| considered radiopaque if the | ||
| specimen has a value of > 1.0 mm | ||
| when compared to the aluminum | ||
| scale, therefore, the value of "X" | ||
| obtained through the equation of | Vittra APS Unique Flow FGM resin is | |
| according to entry requirement for | ||
| Radiopacity, showing results above | ||
| that specified by ISO 4049, so the | ||
| resin can be considered radiopaque. | ||
| the line, must be > 1 | ||
| Radiopacity: 1,825 mm. | ||
| Sensitivity to ambient light | According to the ISO 4049 standard, acceptance is related to the physical homogeneity of the sample, so the material was compared after the test to the same material pressed between coverslips, but without exposure to ambient light. Thus, there is no difference between the samples. | The results presented prove that the FGM Vittra APS Unique Flow resin meets the product entry requirements, being in accordance with the values specified in the ISO 4049 standard in terms of sensitivity to ambient lighting. |
| Water sorption and solubility | According to EN ISO 4049: | |
| Sorption: Maximum of 40 µm/mm³. | ||
| Solubility: maximum of 7.5 µm/mm³. | The results show that the FGM Vittra APS Unique Flow product meets the entry requirement for sorption and water solubility, in accordance with ISO 4049. | |
| Sorption: 26.834 µg/mm³ | ||
| Solubility: 1.632 µg/mm³. | ||
| Accelerated Stability Studies | Study created to accelerate the possible chemical degradation and/or physical changes of the product in forced conditions of storage. | Based on the tests carried out and the results presented over those 274 days, we can guarantee that the Vittra APS Unique Flow product can be marketed for a period of 3 years, provided it is stored within the indicated storage temperature (maximum 30 °C). |
| Evaluation Report of Long-Term Stability (Shelf) | Study designed to verify the physical and chemical characteristics of the product during the expected shelf life. The results are used to confirm the expiration date and storage conditions. | The analysis of Shelf Life has not yet been finalized, the product is being commercialized based on the results of accelerated stability acquired during the prototype. |
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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 color, with three horizontal lines emanating from the left side of the "D", resembling waves or airflow. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in the same muted blue color, completing the brand's visual identity.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
Conclusion: Based on the performance test applied to Vittra APS Unique Flow and the predicate comparison (Opallis Flow), we conclude that the device in question is substantially equivalent with the predicate, as all products meet the same recognized standards.