Vittra APS Unique

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 14, 2021 Dentscare Ltda % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065 Re: K210231/001 Trade/Device Name: Vittra APS Unique Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: July 20, 2021 Received: July 21, 2021 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 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-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, Michael E. Adjodha, M.ChE. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210231 Device Name Vittra APS Unique Indications for Use (Describe) The Vittra APS Unique composite is indicated for use in permanent and deciduous teeth: - Direct restorations in anterior and posterior teeth (Classes I, II, III, IV, V and VI). Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131). ## 510(k) SUMMARY-K210231 - 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) 99160-4500 - E) Preparation Date: October 5, 2021 - F) Classification Name: Tooth shade resin material. Common / Usual Name: Tooth shade resin material. Proprietary Name: Vittra APS Unique Product Code: EBF Class: Class II Regulation: 21 CFR 872.3690 ## G) Product Description Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The composite is radiopaque, with total inorganic load of 72% to 80% in weight (52% to 60% in volume), average particles between 0.8 and 0.9 microns. It does not contain Bis-GMA nor Bis-EMA in its formula, following the present trend of products not made with Bisphenol A (BPA). The composite has APS as its photoinitiation system. APS stands for Advanced Polymerization System, and consists of a combination of different photoinitiators that interact among themselves amplifying the curing capacity of the light emitted by the light-curing device. {4}------------------------------------------------ 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). ## H) Substantial Equivalence: The Vittra APS Unique is equivalent with the following product: | Equivalence | 510(k) Number | Model | Company | |-------------|---------------|------------------|----------------| | Predicate | K191306 | Llis, Vittra APS | Dentscare Ltda | {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 three horizontal lines inside it, accompanied by the text 'DentsCare' in a sans-serif font. 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) Intentions for Use: | Indications for Use Comparison | | |----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Vittra APS Unique | Llis, Vittra APS | | The Vittra APS Unique composite is indicated for use in permanent and deciduous teeth: | The Llis and VITTRA APS composites are suitable for use in: | | - Direct restorations in anterior and posterior teeth<br>(Classes I, II, III, IV, V and VI). | - Direct restorations in anterior and posterior teeth (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. | #### Discussion: All resin composites can be used for both permanent and deciduous teeth. Furthernore, indications for the new device are within those of the predicate. ## J) Technological Characteristics Comparison: The predicate device used to establish substantial equivalence for the Vittra APS Unique device is outlined below. This section of this submission will provide a comparison of decinical specifications of the Vittra APS Unique to the predicate device stratified by functional modality. {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 wave-like 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. | Device Manufacturer and<br>Common Name | Vittra APS Unique<br>Dentscare | Llis, Vittra APS<br>Dentscare | |------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | 510k # | K210231 | K191306 | | 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>Vittra APS Unique must be stored in<br>temperatures between 5° to 30°C | Dental prosthetics and authorized laboratories and<br>clinics.<br>Llis, Vittra APS must be stored in temperatures between<br>5° to 30°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 the<br>same human tissues<br>or body fluids? | YES | YES | | Is the product in compliance to<br>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<br>condition? | yes | yes | | Is it used at the same site in the<br>body? | yes | yes | | Is it used in a similar<br>population? | yes | yes | | Is it used for the same intended<br>purpose? | yes | yes | | Is not foreseen to deliver<br>significantly different<br>performances? | no | no | | Is it similar conditions of use? | yes | yes | | Is it similar specifications and<br>properties | yes | yes | | Is it similar principles of<br>operation? | yes | yes | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter D with three horizontal lines inside the curve of the D, suggesting movement or flow. Below the symbol, the word "DentsCare" is written in a sans-serif font, with the "D" in a larger size and a slightly different shade than the rest of the word. | CLINICAL STEP | Vittra APS Unique (Dentscare) | LLis, Vitra APS (Dentscare) | |-----------------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------| | Two options: total dam isolation<br>or relative isolation | YES | YES | | Application according to<br>adhesive technique | YES | YES | | Size for increments | 1.5 mm | 1.5-2 mm | | Light curing unit | Power: ≥ 450mW/cm2<br>Wavelength: 400-500nm | Power: Llis ≥ 450mW/cm2, Vittra APS 700mW/ cm2<br>Wavelength: 400-500nm | | Require finishing and polishing | YES | YES | | Specification | Vittra APS Unique | Llis | Vittra APS | |-------------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------| | Sensitivity to ambient light | physically homogeneous | physically homogeneous | physically homogeneous | | Depth of cure | 4.91 mm | 2.44 mm | 2.43 mm | | Flexural strength | 137.8 MPa | 138.8 MPa | 142.6 MPa | | Water sorption and solubility | Sorption: 7.93 µg/mm³<br>Solubility: 1.59 µg/mm³ | Sorption: 16.32 µg/mm³<br>Solubility: 4.78 µg/mm³ | Sorption: 15.55 µg/mm³<br>Solubility: 4.06 µg/mm³ | | Radio-opacity | 2.23 mm | 1.98 mm | 2.31mm | | Color stability | The observers did not attest any difference of color | The observers did not attest any difference of color | The observers did not attest any difference of color | | Tensile Bond | Not requested by ISO 4049 | | | | Shear Bond Strength | Not requested by ISO 4049 | | | {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 sans-serif font. 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). #### Discussion: The subject device is 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 4049:2019 minimum requirements. Despite the minor differences in formulation between the subject device 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 gray color, with three horizontal lines emanating from the left side of the "D", resembling sound waves or air currents. Below the symbol is the text "DentsCare" in a bold, sans-serif font, also in gray. ITDA R NELSON MEISTER, 474, JOINVILLE, ARINA 89219-501 BRAZIL 47 - 3441-6131 ## K) Applicable Standards: In order to reach substantially equivalent to the predicate device Vittra APS Unique 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 (EN ISO 10993-1:2009) #### Conclusion: Based on compliance with the international standard and regulation mentioned above, the device Vittra APS Unique demonstrates equivalency to the predicate device. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains 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. | Test | Specification | Results | Report | |---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Sensitivity to<br>environment<br>lighting -<br>ISO 4049 | According to the ISO 4049<br>standard, acceptance is related<br>to the physical homogeneity of<br>the sample, so the material<br>was compared after the test to<br>the same material pressed<br>between coverslips, but<br>without exposure to ambient<br>light. Thus, there is no<br>difference between the<br>samples. | After to read samples in triplicate,<br>it was found that all samples were<br>presented to be physically<br>homogeneous, thus Vittra APS<br>Unique and the predicate device<br>meet the specifications of the ISO<br>4049 standard. | | | Depth of<br>Cure - ISO<br>4049 | According to ISO 4049, the<br>specified for this material is<br>that its curing depth is: > 1.5<br>mm. | The results showed that the<br>subject device and predicate<br>device are according the entry<br>requirement related to the depth of<br>cure and the values specified in<br>ISO 4049.<br>Vittra APS Unique: 4.91 mm<br>Llis: 2.44 mm<br>Vittra APS: 2.43 mm | | | Colour tone<br>stability<br>after<br>radiation<br>and water<br>absorption -<br>ISO 4049<br>and<br>ISO<br>7491 | The acceptance must be<br>performed provided that there<br>is no more than a small change<br>in colour, it must be proven as<br>follows:<br>a) comparisons should be<br>made by visual inspection and<br>analysed by three observers<br>with normal vision, who do not<br>identify any differences in | All comparisons were carried out<br>by observers with normal eyesight.<br>They did not attest to any color<br>difference in the samples analysed.<br>The results presented prove that<br>the Vittra APS Unique, Llis and<br>Vittra APS resins are in accordance<br>with products entry requirements<br>as specified in the ISO4049<br>standard. | | | | | | | | | colour, this comparison must<br>be carried at a distance of 200<br>to 300 mm for a period of no<br>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%<br>approximate reflectance, and it<br>should have as a limiting size<br>the size of the specimen, which<br>must be surrounded by a grey<br>background with a diffuse<br>reflectance of 30 ± 5%. | | | | Radiopacity -<br>ISO 4049 | According to ISO 4049, the<br>material is 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 > $1$ . | The average results obtained for<br>radiopacity of Vittra Unique APS<br>FGM was $2.23$ , thus being higher<br>than that specified in ISO 4049.<br>Vittra APS Unique: $2.23$ mm<br>Llis: $1.98$ mm<br>Vittra APS: $2.31$ mm | | | Flexing<br>Resistance -<br>ISO 4049 | According to the ISO 4049<br>standard the specification for<br>flexural strength is ≥ $80$ MPa. | All results below are within the<br>specified limit, so the materials<br>follow ISO 4049.<br>Vittra APS Unique: $137.8$ MPa<br>Llis: $138.8$ MPa<br>Vittra APS: $142.6$ MPa | | | Water<br>sorption and<br>solubility. | Sorption: Maximum of $40$ μm/mm3. | The results show that Vittra APS<br>Unique and the predicate device<br>products meet the entry | | | - ISO 4049 | Solubility: maximum of 7.5 μm/mm³. | requirement for sorption and water<br>solubility, in accordance with ISO<br>4049.<br><br>Sorption/Solubility (µg/mm³)<br>Vittra APS Unique: 7.93 / 1.59<br>Llis: 16.32 / 4.78<br>Vittra APS: 15.55 / 4.06 | | | 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. | Considering the results observed at<br>the end of the 274 days test period,<br>the shelf-life of 3 years in the<br>storage condition of 30 °C for the<br>product can be confirmed. | | | Long-term<br>Stability<br>Study | 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<br>storage conditions. | Shelf-life test has not yet been<br>completed, the product is being<br>commercialized based on the<br>results of accelerated stability<br>acquired during the prototype. | | {11}------------------------------------------------ Image /page/11/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 symbol is the text "DentsCare" in a sans-serif font, also in gray. {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, with three horizontal lines emanating from the left side of the "D", resembling airflow. Below the symbol 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 Ph: 55 - 47 - 3441-6131 Conclusion: Based on the performance test applied to this Vittra APS Unique and the predicate (Llis, Vittra APS) comparison, we conclude that the subject device is substantially equivalent with the predicates, since all products, meet the same recognized standard.