Llis, Vittra APS

{0}------------------------------------------------ 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. December 16, 2019 Dentscare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065 Re: K191306 Trade/Device Name: Llis, Vittra APS Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: September 13, 2019 Received: September 17, 2019 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 (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. 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 {1}------------------------------------------------ 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 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-regulatoryassistance/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, for Srinivas 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K191306 Device Name Llis and VITTRA APS Indications for Use (Describe) The Llis and VITTRA APS composite is suitable for use in: - Direct restorations in anterior and posterior teeth (I, II, III, IV, V e VI); - Core build-ups; - Teeth splinting; - Indirect restorations such as inlays, onlays and veneers. - Direct veneers with composites; - Restoration of deciduous teeth - Diastema closing or reduction; - Modification of teeth's shape (e.g .: conoid teeth); - Cementation of tooth fragments; - Porcelain/composite repairs: Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> <span>Research Use (Per 21 CFR 361.2, Subpart B)</span> </div> | |--------------------------------------------------------------------------------------------------------------| | <div> <input type="checkbox"/> <span>Over-The-Counter Use (21 CFR 361.2, Subpart C)</span> </div> | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Section 5 510(k) SUMMARY (K191306) - 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: Roberta Uyara Tel.: +55 (47) 34416131 - E) Preparation Date: May 7, 2019 - F) Classification Name: Tooth shade resin material. Common / Usual Name: Tooth shade resin material. Proprietary Name: Llis, VITTRA APS Product Code: EBF Class: Class II Regulation: 21 CFR 872.3690 ### G) Device Description #### Llis Llis is a radiopaque composite for anterior and posterior restorations. Its composition was based in modern concepts so that methacrylate monomers, silanes and fillers with adequate size distribution were combined to produce a product with differentiated physical, mechanical and optical properties. Llis presents a simplified shade system, offering enamel, dentin and incisal shades. {4}------------------------------------------------ Image /page/4/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 company's address, which is AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and their phone number, which is Ph: 55 - 47 - 3441-6131. ### Vittra APS Vittra APS is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth. The composite is radiopaque; its loading particles are composed by spheres of a zirconia complex with average load particle size of 200nm, with total inorganic load of 72% to 82% in weight (52% to 60% in volume). Those characteristics contribute to enhance both mechanical and aesthetic properties, especially evidenced by how easy it is to obtain proper polishing and by the long-lasting surface shining. Vittra APS' formula is free of Bis-GMA and Bis-EMA, following the present trend of products free of Bisphenol A (BPA). APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photoinitiators that interact among each other amplifying the curing capacity of light emitted from light-curing units. Added to different materials, the system provides different advantages. In the case of Vittra APS, APS adds as main benefit the reduction or elimination of visual shade and opacity alteration before/after light curing, which enhances the predictability of the result. Another factor is that, although there is very little concentration of camphorquinone - that has a yellowish aspect - APS has great power of polymerization allowing greater degree of conversion. The APS system is activated by any type of lightcuring unit available on the market, even those with less power or narrow range of wavelength. ### H) Substantial Equivalence: The Llis, VITTRA APS is equivalent with the following products: | 510(k) Number | Model | Company | |---------------|---------------------------------------------------|------------| | K183476 | 3MTM ESPETM FiltekTMZ250 Universal<br>Restorative | 3M COMPANY | {5}------------------------------------------------ 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 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). ### I) Intentions for Use: | Intention of Use Comparison | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Llis, VITTRA APS | 3M™ ESPE™ Filtek™ Z250 Universal Restorative | | The Llis and VITTRA APS composite is suitable for use in:<br>- Direct restorations in anterior and posterior teeth<br>(I, II, III, IV, V e VI);<br>- Core build-ups;<br>- Teeth splinting;<br>- Indirect restorations such as inlays, onlays and veneers.<br>- Direct veneers with composites;<br>- Restoration of deciduous teeth<br>- Diastema closing or reduction;<br>- Modification of teeth´s shape (e.g.: conoid teeth);<br>- Cementation of tooth fragments;<br>- Porcelain/composite repairs; | The Filtek™ Z250 Universal Restorative composite is suitable for use in:<br>- Direct anterior and posterior restorations<br>- Core buildups<br>- Splinting<br>- Indirect restorations including inlays, onlays and veneers | #### Discussion: The terms found in the intended for use declaration is using different wording, but essentially is intended to similar procedures. Below is the list of terms with its definition showing the substantially equivalence with the predicate device. - The term "direct veneers with composites": Direct veneers can be included in the "anterior restorations" indications. - The term "Restoration of deciduous teeth": All resin composites can be used for both permanent or primary teeth. - - The term "Diastema closing or reduction of teeth's shape": These procedures can be performed with any composite compatible to dental adhesives. - The term "Cementation of tooth fragments and repairs to porcelain or composite" can be performed with any composite compatible to dental adhesives. {6}------------------------------------------------ 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 address 'AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL' and the phone number 'Ph: 55 - 47 - 3441-6131'. #### J) Technological Characteristics Comparison: The predicate device used to establish substantial equivalence for the Llis, VITTRA APS device is outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Lis, VITTRA APS to each of the predicate devices stratified by functional modality. | Device Manufacturer and<br>Common Name | Llis, VITTRA APS<br>Dentscare | 3M™ Filtek™ Z250 Universal Restorative<br>3M Company | |------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k # | Not assigned yet | K183476 | | Classification | Class II | Class II | | Regulation # | 21 CFR 872.3690 | 21 CFR 872.3690 | | Product Code | EBF | 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<br>and clinics.<br>Llis, VITTRA APS must be stored in temperatures<br>between 5° to 30°C | Dental prosthetics and authorized laboratories and<br>clinics.<br>3M™ ESPE™ Filtek™ Z250 Universal Restorative<br>must be stored in temperatures up to 27°C | | Applicable Standards | ISO 4049 ; ISO 10993-1 | ISO 4049 ; ISO 10993-1 | | 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<br>substances in contact with<br>the same human tissues<br>or body fluids? | YES | YES | | Is the product in<br>compliance to EN ISO<br>10993 ? | YES | YES | {7}------------------------------------------------ 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 wave-like lines inside it, accompanied by the company name 'DentsCare' in a sans-serif font. The contact information includes the company's address on AV. EDGAR NELSON MEISTER, 474, in JOINVILLE, SANTA CATARINA, with the postal code 89219-501 in BRAZIL, as well as the phone number Ph: 55 - 47 - 3441-6131. | 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<br>clinical condition? | yes | yes | | Is it used at the same site<br>in the body? | yes | yes | | Is it used in a similar<br>population? | yes | yes | | Is it used for the same<br>intended purpose? | yes | yes | | Is not foreseen to deliver<br>significantly different<br>performances? | no | no | | Is it similar conditions of<br>use? | yes | yes | | Is it similar specifications<br>and properties | yes | yes | | Is it similar principles of<br>operation? | yes | yes | | CLINICAL STEP | LLis and Vitra APS (FGM) | Z250 (3M ESPE) | |--------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------| | Two options: total dam<br>isolation or relative<br>isolation | YES | YES | | Application according to<br>adhesive technique | YES | YES | | Size for increments | 1,5-2mm | 2-2,5mm | | Lightcuring unit | POWER $\geq$ 450mW/cm2 and WAVELENGTH OF<br>400-500nm | POWER $\geq$ 400mW/cm2 and WAVELENGTH OF 400-<br>500nm | | Require finishing and<br>polishing | YES | YES | | Specification | Llis | Vittra APS | Filtek TM Z250 Universal Restorative | |------------------------------|------------------------|------------------------|------------------------------------------------------| | Sensitivity to ambient light | physically homogeneous | physically homogeneous | physically homogeneous | {8}------------------------------------------------ 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 wave-like lines inside, accompanied by the text 'DentsCare' in a modern font. 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. | Depth of cure | 2.44 mm | 2.43 mm | 2.39 mm | |---------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------| | Flexural strength | 138.8 MPa | 142.6 MPa | 143.8 MPa | | Water sorption and | Sorption: 16.32 µg/mm3 | Sorption: 15.55 µg/mm3 | Sorption: 15.29 µg/mm3 | | solubility | Solubility: 4.78 µg/mm3 | Solubility: 4.06 µg/mm3 | Solubility: 4.09 µg/mm3 | | Radio-opacity | 1.98 mm | 2.31 mm | 1.94 mm | | Color stability | The observers do not attested<br>any difference of color | The observers do not attested<br>any difference of color | The observers do not attested any<br>difference of color | | Tensile Bond | Not requested by ISO 4049 | | | | Shear Bond Strength | Not requested by ISO 4049 | | | #### Discussion: The subject devices are similar to the predicate device in that they are light activated, radio-opaque and restorative composite to be used for permanently cementing restorations. The subject device have substantially equivalent of indications for use, mode of use, technological properties and fulfil the EN ISO 4049:2009 minimum requirements. Despite the minor differences in formulation between the subject devices and the predicate, they can be considered equivalent, since these differences does not affect the product's laboratorial and clinical performance and safety. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color. Three horizontal lines are placed within the upper part of the "D", suggesting movement or airflow. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in the same muted blue-gray color. RF I TDA GAR NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131 ## K) Applicable Standards: In order to reach substantially equivalent to the predicate device Llis, VITTRA APS was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry. ISO 4049 - Dentistry - Polymer-based restorative materials ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ENISO 10993-1:2009) #### Conclusion: Based on compliance with the international standard and regulation mentioned above, the device Llis, VITTRA APS demonstrate equivalency to the predicate device. {10}------------------------------------------------ Image /page/10/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 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). ## L) Non-clinical Testing: In order to study the performance of the product, pre-clinical tests were performed according to the table below, for details about test results please see attachments below. ## LLIS | Test | Specification | Results | Report | |------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Sensitivity to<br>environment<br>lighting - ISO<br>4049 | According to the ISO 4049<br>standard, acceptance is related to<br>the physical homogeneity of the<br>sample, so the material was<br>compared after the test to the<br>same material pressed between<br>coverslips, but without exposure to<br>ambient light. Thus, there is no<br>difference between the samples. | All results are within the range specified<br>by ISO 4049. | ATTACHMENT 01<br>- SENSITIVITY TO<br>ENVIRONMENT<br>LIGHTING | | Depth of Cure -<br>ISO 4049 | According to ISO 4049, the<br>specification for this material is<br>that its curing depth is: > 1.0 mm<br>for opaque materials and > 1.5<br>mm for non-opaque materials. | All results are greater than the specified<br>threshold, therefore the material is<br>considered to be in conformity. | ATTACHMENT 02 -<br>DEPTH OF CURE | | Colour tone<br>stability after<br>radiation and<br>water<br>absorption -<br>ISO 4049 and<br>ISO 7491 | The acceptance must be<br>performed provided that there is<br>no more than a small change in<br>color, it must be proven as follows:<br>a)   comparisons should be<br>made by visual inspection and<br>analysed by three observers with<br>normal vision, who do not identify<br>any differences in color, this<br>comparison must be carried at a<br>distance of 200 to 300 mm for a<br>period of no more than 2 seconds;<br>b)   perform the comparison<br>cited in a) in a light chamber at<br>Day Light - D65 mode;<br>c)   perform the comparison in<br>paragraph a), by placing the<br>specimen on a diffuse white<br>background of 90% approximate<br>reflectance, and it should have as<br>a limiting size the size of the<br>specimen, which must be<br>surrounded by a grey background<br>with a diffuse reflectance of 30 ±<br>5%. | All comparisons were carried out by<br>three observers with normal eyesight<br>(Tiago Vicente, Josley Habinzeureuter<br>and Simone Brasil Carvalho), certified<br>by a competent physician. They did not<br>attest to any color difference in the<br>samples analyzed.<br>The results demonstrate that the<br>product meets ISO 4049. | ATTACHMENT 03 -<br>COLOR TONE<br>STABILITY AFTER<br>RADIATION AND<br>WATER<br>ABSORPTION | | Radiopacity -<br>ISO 4049 | Compare the individual optical<br>drives of each aluminium scale<br>against the density of each scale<br>(this check must be performed<br>using ISO 4049 as reference). Get<br>the value of the optical<br>density/grey value for the δs<br>thickness of the specimen and<br>determine the corresponding<br>value of aluminium, δα. | The values found in the specimens are<br>between the second and third scale of<br>the aluminum part, proving that the<br>material is radiolucent according to the<br>requirements of ISO 4049 | ATTACHMENT 04 -<br>RADIOPACITY | | Flexing<br>Resistance -<br>ISO 4049 | According to the EN ISO 4049<br>standard the specification for<br>flexural strength is ≥80MPa. | All results are greater than the specified<br>threshold, therefore the material is<br>considered as conformant. | ATTACHMENT 05 -<br>FLEXING<br>RESISTANCE | | Water sorption<br>and solubility.<br>- ISO 4049 | Sorption: Maximum of 40 µm/mm³.<br>Solubility: maximum of 7.5<br>μm/mm³. | The results demonstrate that the<br>product complies the specification in the<br>EN ISO 4049 Standard. | ATTACHMENT 06 -<br>WATER SORPTION<br>AND SOLUBILITY | | Accelerated<br>Stability 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. | Considering the results observed at the<br>end of the 274 days test period, the<br>shelf-life of 3 years in the storage<br>condition of 30 °C for the product can be<br>confirmed. | ATTACHMENT 07 -<br>ACCELERATED<br>STABILITY STUDIES | | Evaluation<br>Report Of Long-<br>Term Stability<br>(Shelf) | Study designed to verify the<br>physical and chemical<br>characteristics of the product<br>during the expected shelf life. The<br>results are used to confirm the<br>expiration date and storage<br>conditions. | Considering the results observed at the<br>end of the 36 months of the long-term<br>test (shelf), the shelf life of 3 years in<br>the storage condition of 30°C for the<br>product can be confirmed. | ATTACHMENT 08 -<br>EVALUATION<br>REPORT OF LONG-<br>TERM STABILITY<br>(SHELF) | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" with three horizontal lines inside the upper part of the "D", resembling waves. Below the symbol is the word "DentsCare" in a simple, sans-serif font. The color of the logo is a muted gray-blue. DENTSCARE LTDA AV. EDGAR NELSON MELSON MEISTER, 474, JOINVILLE, # VITTRA APS | Test | Specification | Results | Report | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Sensitivity to<br>environment lighting<br>– ISO 4049 | According to the ISO 4049 standard,<br>acceptance is related to the physical<br>homogeneity of the sample, so the<br>material was compared after the test<br>to the same material pressed between<br>coverslips, but without exposure to<br>ambient light. Thus, there is no<br>difference between the samples. | All results are within the range<br>specified by ISO 4049. | ATTACHMENT 09 –<br>SENSITIVITY TO<br>ENVIRONMENT<br>LIGHTING | | Depth of Cure - ISO<br>4049 | According to ISO 4049, the<br>specification for this material is that its<br>curing depth is: > 1.0 mm for opaque<br>materials and > 1.5 mm for non-<br>opaque materials. | All results are greater than the<br>specified threshold, therefore<br>the material is considered to<br>be in conformity. | ATTACHMENT 10 –<br>DEPTH OF CURE | | Colour tone stability<br>after radiation and<br>water absorption -<br>ISO 4049 | The acceptance must be performed<br>provided that there is no more than a<br>small change in color, it must be<br>proven as follows:<br><br>a) comparisons should be made<br>by visual inspection and analysed by<br>three observers with normal vision,<br>who do not identify any differences in<br>color, this comparison must be carried<br>at a distance of 200 to 300 mm for a<br>period of no more than 2 seconds;<br><br>b) perform the comparison cited<br>in a) in a light chamber at Day Light -<br>D65 mode;<br><br>c) perform the comparison in<br>paragraph a), by placing the specimen<br>on a diffuse white background of 90%<br>approximate reflectance, and it should<br>have as a limiting size the size of the<br>specimen, which must be surrounded<br>by a grey background with a diffuse<br>reflectance of 30 ± 5%. | All comparisons were carried<br>out by three observers with<br>normal eyesight (Tiago<br>Vicente, Josley<br>Habinzeureuter and Simone<br>Brasil Carvalho), certified by a<br>competent physician. They<br>did not attest to any color<br>difference in the samples<br>analyzed.<br><br>The results demonstrate that<br>the product meets ISO 4049. | ATTACHMENT 11 -<br>COLOUR TONE<br>STABILITY AFTER<br>RADIATION AND<br>WATER<br>ABSORPTION. | | Radiopacity - ISO<br>4049 | Compare the individual optical drives<br>of each aluminium scale against the<br>density of each scale (this check must<br>be performed using ISO 4049 as<br>reference). Get the value of the optical<br>density/grey value for the δs thickness<br>of the specimen and determine the<br>corresponding value of aluminium, δa. | The values found in the<br>specimens are between the<br>second and third scale of the<br>aluminum part, proving that<br>the material is radiolucent<br>according to the requirements<br>of ISO 4049 | ATTACHMENT 12 -<br>RADIOPACITY | | Flexing Resistance -<br>ISO 4049 | According to the EN ISO 4049<br>standard the specification for flexural<br>strength is ≥80MPa. | All results are greater than the<br>specified threshold, therefore<br>the material is considered as<br>conformant. | ATTACHMENT 13 -<br>FLEXING<br>RESISTANCE | | Water sorption and<br>solubility.<br>- ISO 4049 | Sorption: Maximum of 40 µm/mm³.<br><br>Solubility: maximum of 7.5 µm/mm³. | The results demonstrate that the<br>product complies the<br>specification in the EN ISO<br>4049 Standard. | ATTACHMENT 14 -<br>WATER SORPTION<br>AND SOLUBILITY. | | Accelerated Stability<br>Studies | Study created to accelerate the<br>possible chemical degradation and/or<br>physical changes of the product in<br>forced conditions of storage. | Considering the results<br>observed at the end of the<br>274 days test period, the<br>shelf-life of 3 years in the<br>storage condition of 30 °C for<br>the product can be confirmed. | ATTACHMENT 15 -<br>ACCELERATED<br>STABILITY STUDIES | | Evaluation Report Of<br>Long-Term Stability | Study designed to verify the physical<br>and chemical characteristics of the | Considering the results<br>observed at the end of the 36 | ATTACHMENT 16 -<br>EVALUATION | | (Shelf) | product during the expected shelf life.<br>The results are used to confirm the<br>expiration date and storage conditions. | months of the long-term test<br>(shelf), the shelf life of 3 years<br>in the storage condition of<br>30°C for the product can be<br>confirmed. | REPORT OF LONG-<br>TERM STABILITY<br>(SHELF) | | Color change during<br>polymerization -<br>Study carried out at<br>Universidade<br>Estadual de Ponta<br>Grossa (UEPG) and<br>Universidade Federal<br>do Maranhão | A comparative analysis will be carried<br>out between commercial composites<br>of internationally recognised quality<br>and the composite under analysis. It is<br>defined that the acceptance criterion<br>for this test is if the composite under<br>study has a value statistically ≤ than<br>the competing composites analysed. | Vittra APS showed the least<br>change in color, being similar<br>to the resins Estelite Quick<br>(Tokuyama) and Filtek Z350<br>XT (3M ESPE). | ATTACHMENT 17<br>- COLOR CHANGE<br>DURING<br>POLYMERIZATION | | Knoop hardness<br>Study carried out at<br>Universidade<br>Estadual de Ponta<br>Grossa (UEPG) and<br>Universidade Federal<br>do Maranhão | A comparative analysis will be carried<br>out between commercial composites<br>of internationally recognised quality<br>and the composite under analysis. It is<br>defined that the acceptance criterion<br>for this test is if the composite under<br>study has a value statistically ≥ than<br>the competing composites analysed. | Vittra APS showed greater<br>surface hardness among the<br>composites that participated<br>in the trial, showing surprising<br>Such<br>values.<br>hardness<br>originates in the quality,<br>morphology and content of<br>the loads used as well as in<br>the quality of the polymers<br>formed and its integration with<br>those loads. | ATTACHMENT 18<br>- KNOOP<br>HARDNESS | | Conversion rate<br>Study carried out at<br>Universidade<br>Estadual de Ponta<br>Grossa (UEPG) and<br>Universidade Federal<br>do Maranhão | A comparative analysis will be carried<br>out between commercial composites<br>of internationally recognised quality<br>and the composite under analysis. It is<br>defined that the acceptance criterion<br>for this test is if the composite under<br>study has a value statistically ≥ than<br>the competing composites analysed. | APS<br>Vittra<br>showed<br>a<br>conversion degree statistically<br>equal to the best results of the<br>other materials under analysis<br>within a<br>considered<br>and<br>range.<br>The<br>excellent<br>mechanical<br>results<br>demonstrated<br>are<br>an<br>evidence for that observation. | ATTACHMENT 19<br>- CONVERSION<br>RATE | | Elasticity Module<br>Study carried out at<br>Universidade<br>Estadual de Ponta<br>Grossa (UEPG) and<br>Universidade Federal<br>do Maranhão | A comparative analysis will be carried<br>out between commercial composites<br>of internationally recognised quality<br>and the composite under analysis. It is<br>defined that the acceptance criterion<br>for this test is if the composite under<br>study has a mean equal to or slightly<br>less than that of human dentin (10-15<br>Gpa). | Vittra<br>APS<br>showed<br>an<br>elasticity module superior to<br>the one of resins Estelite<br>Quick (Tokuyama Dental) and<br>Tetric<br>N-Ceram<br>(Ivoclar<br>Vivadent), being compatible to<br>the lowest limiting value that<br>is attributed to the human<br>dentine. | ATTACHMENT 20<br>- ELASTICITY<br>MODULE | | Compressive<br>Strenght<br>Study carried out at | A comparative analysis will be carried<br>out between commercial composites<br>of internationally recognised quality | It is noticeable that Vittra APS<br>showed compressive strength<br>statistically equal to the best | ATTACHMENT 21<br>– COMPRESSIVE | | Universidade<br>Estadual de Ponta<br>Grossa (UEPG) and<br>Universidade Federal<br>do Maranhão | and the composite under analysis. It is<br>defined that the acceptance criterion<br>for this test is if the composite under<br>study has a value statistically ≥ than<br>the competing composites analysed. | results of the other materials<br>under analysis. | STRENGTH | | Flexural Resistance<br>ISO 4049<br>Study carried out at<br>Universidade<br>Estadual de Ponta<br>Grossa (UEPG) and<br>Universidade Federal<br>do Maranhão | According to the EN ISO 4049<br>standard, the specification for flexural<br>strength is ≥80MPa. | The result shows that Vittra<br>APS has excellent bending<br>resistance,<br>statistically<br>comparable or superior to<br>products already well known<br>in the market. | ATTACHMENT 22<br>- FLEXURAL<br>RESISTANCE | | Roughness before<br>and after simulated<br>brushing.<br>Study carried out at<br>Universidade<br>Estadual de Ponta<br>Grossa (UEPG) and<br>Universidade Federal<br>do Maranhão | A comparative analysis will be carried<br>out between commercial composites<br>of internationally recognised quality<br>and the composite under analysis. It is<br>defined that the acceptance criterion<br>for this test is if the composite under<br>study has a value ≤ than<br>competing composites analysed. | Vittra APS was the only<br>composite that did not show<br>increase in surface roughness<br>after simulated brushing. The<br>result demonstrates high<br>resistance to abrasion and<br>reflects the properties that<br>were already expected due to<br>the high Knoop Hardness<br>value that the product has.<br>From a practical point of view,<br>it is noticeable that Vittra APS<br>showed an increase in the<br>smoothness of the product,<br>which explains the long<br>lasting maintenance of its<br>shine | ATTACHMENT 23<br>- ROUGHNESS<br>BEFORE AND<br>AFTER<br>SIMULATED<br>BRUSHING. | | Fracture Toughness.<br>Study carried out at<br>Universidade<br>Estadual de Ponta<br>Grossa (UEPG) and<br>Universidade Federal<br>do Maranhão | A comparative analysis will be carried<br>out between commercial composites<br>of internationally recognised quality<br>and the composite under analysis. It is<br>defined that the acceptance criterion<br>for this test is if the composite under<br>study has a value statistically ≥ than<br>the competing composites analysed. | Vittra APS showed fracture<br>toughness statistically equal<br>to the best results of the other<br>materials under analysis. | ATTACHMENT 24<br>- FRACTURE<br>TOUGHNESS. | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Three horizontal lines are coming out of the left side of the "D", suggesting movement or flow. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines inside the "D" to represent teeth. Below the "D" is the text "DentsCare" in a sans-serif font, also in gray. DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL DentsCare ph: 55 - 47 - 3441-6131 {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. To the left of the "D" are three horizontal lines that appear to be a design element. Below the "D" is the word "DentsCare" in a sans-serif font, also in gray. 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 this Llis, VITTRA APS and the predicate comparison, we conclude that the subject device is substantially equivalent with the predicate.