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.

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.

AI/ML Overview

The Dentscare LTDA Llis and VITTRA APS devices are tooth shade resin materials. The provided text outlines the acceptance criteria and study results for these devices.

Acceptance Criteria and Device Performance (Llis and Vittra APS)

The acceptance criteria are generally defined by compliance with ISO 4049 (Dentistry - Polymer-based restorative materials) and in some cases, by comparison to commercially available, internationally recognized quality composites.

Test	Acceptance Criteria	Reported Device Performance
Llis
Sensitivity to environment lighting	Physical homogeneity after testing, with no difference compared to material pressed between coverslips without ambient light exposure (ISO 4049).	All results are within the range specified by ISO 4049.
Depth of Cure	> 1.0 mm for opaque materials and > 1.5 mm for non-opaque materials (ISO 4049).	All results are greater than the specified threshold, conforming to the standard. (Llis: 2.44 mm; Vittra APS: 2.43 mm reported in Section J. The individual test result for Vittra APS is also stated as "All results are greater than the specified threshold").
Color tone stability after radiation and water absorption	No more than a small change in color, and three observers with normal vision identify no differences in color after visual inspection at 200-300 mm distance for <2 seconds in a Day Light - D65 mode light chamber, with a white (90% reflectance) background and gray (30 ± 5% reflectance) surround (ISO 4049 and ISO 7491).	All comparisons were carried out by three observers with normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician. They did not attest to any color difference in the samples analyzed. The results demonstrate that the product meets ISO 4049.
Radiopacity	Compare individual optical drives of each aluminum scale against the density of each scale using ISO 4049 as reference, determining the corresponding aluminum value.	The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according to the requirements of ISO 4049. (Llis: 1.98 mm; Vittra APS: 2.31 mm reported in Section J. The individual test result for Vittra APS also states "The values found in the specimens are between the second and third scale of the aluminum part").
Flexing Resistance (Flexural Strength)	≥80MPa (EN ISO 4049).	All results are greater than the specified threshold, conforming to the standard. (Llis: 138.8 MPa; Vittra APS: 142.6 MPa reported in Section J. The individual test result for Vittra APS states "All results are greater than the specified threshold", furthermore, "Vittra APS has excellent bending resistance, statistically comparable or superior to products already well known in the market").
Water sorption and solubility	Sorption: Maximum of 40 µm/mm³. Solubility: maximum of 7.5 μm/mm³ (EN ISO 4049).	The results demonstrate that the product complies with the specification in EN ISO 4049 Standard. (Llis sorption: 16.32 µg/mm³, solubility: 4.78 µg/mm³; Vittra APS sorption: 15.55 µg/mm³, solubility: 4.06 µg/mm³ reported in Section J).
Accelerated Stability Studies	Study created to accelerate possible chemical degradation and/or physical changes in forced storage conditions, confirming a 3-year shelf-life at 30°C.	Considering the results observed at the end of the 274 days test period, the shelf-life of 3 years in the storage condition of 30 °C for the product can be confirmed.
Evaluation Report Of Long-Term Stability (Shelf)	Study designed to verify physical and chemical characteristics during expected shelf life, confirming expiration date and storage conditions, for a 3-year shelf-life.	Considering the results observed at the end of the 36 months of the long-term test (shelf), the shelf life of 3 years in the storage condition of 30°C for the product can be confirmed.
Vittra APS (Additional Tests)
Color change during polymerization	Statistically ≤ than competing commercially available, internationally recognized quality composites.	Vittra APS showed the least change in color, being similar to the resins Estelite Quick (Tokuyama) and Filtek Z350 XT (3M ESPE).
Knoop hardness	Statistically ≥ than competing commercially available, internationally recognized quality composites.	Vittra APS showed greater surface hardness among the composites that participated in the trial, showing surprising such values. This originates from the quality, morphology, and content of the loads used, as well as the quality of the polymers formed and its integration with those loads.
Conversion rate	Statistically ≥ than competing commercially available, internationally recognized quality composites.	Vittra APS showed a conversion degree statistically equal to the best results of the other materials under analysis within a considered range. The excellent mechanical results demonstrated are an evidence for that observation.
Elasticity Module	Mean equal to or slightly less than that of human dentin (10-15 GPa).	Vittra APS showed an elasticity module superior to the one of resins Estelite Quick (Tokuyama Dental) and Tetric N-Ceram (Ivoclar Vivadent), being compatible to the lowest limiting value that is attributed to the human dentine.
Compressive Strength	Statistically ≥ than competing commercially available, internationally recognized quality composites.	It is noticeable that Vittra APS showed compressive strength statistically equal to the best results of the other materials under analysis.
Roughness before and after simulated brushing	Statistically ≤ than competing commercially available, internationally recognized quality composites.	Vittra APS was the only composite that did not show increase in surface roughness after simulated brushing. The result demonstrates high resistance to abrasion, reflecting properties expected due to its high Knoop Hardness value. Practically, Vittra APS showed an increase in smoothness, explaining the long-lasting maintenance of its shine.
Fracture Toughness	Statistically ≥ than competing commercially available, internationally recognized quality composites.	Vittra APS showed fracture toughness statistically equal to the best results of the other materials under analysis.

Study Information for Llis and VITTRA APS

The studies mentioned are non-clinical tests conducted to assess the physical and chemical properties of the devices.

Sample size used for the test set and the data provenance:
- The specific sample sizes for each test (e.g., number of specimens for depth of cure, flexural strength) are not explicitly stated in the provided text, beyond the mention of "samples analyzed" or "specimens."
- The data provenance for some Vittra APS tests (Color change during polymerization, Knoop hardness, Conversion rate, Elasticity Module, Compressive Strength, Flexural Resistance, Roughness before and after simulated brushing, Fracture Toughness) is identified as studies carried out at "Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão." This suggests the data is likely retrospective lab-based testing.
- For the standard ISO tests for both Llis and Vittra APS, the text refers to "All results are within the range specified by ISO 4049" or "All results are greater than the specified threshold," implying in-house lab testing for current product batches. The country of origin for Dentscare LTDA is Brazil.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Color tone stability after radiation and water absorption test for both Llis and Vittra APS, three observers were used.
- Qualifications: They possessed "normal eyesight" and were "certified by a competent physician."
Adjudication method for the test set:
- For the Color tone stability test, the acceptance criterion specifically states that "three observers with normal vision, who do not identify any differences in color" must make the comparison. This implies a unanimous consensus among the three certified experts for acceptance.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving human readers or AI assistance is mentioned. The devices are dental restorative materials, and the testing focuses on their physical and chemical properties, not diagnostic or interpretive effectiveness.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. These are physical dental restorative materials, not algorithmic software devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Consensus: For the "Color tone stability after radiation and water absorption" test, the ground truth was established by the consensus of three certified observers regarding color difference.
- Standard Specifications/Reference Values: For most other tests (e.g., Depth of Cure, Flexural Strength, Water Sorption, Radiopacity), the ground truth is based on the quantitative specifications outlined in international standards like ISO 4049 or comparison to known reference materials (e.g., aluminum scale for radiopacity, human dentin for elasticity module).
- Comparative Performance: For some Vittra APS-specific tests (color change during polymerization, Knoop hardness, conversion rate, compressive strength, roughness, fracture toughness), the ground truth was defined by criteria relative to the performance of "commercial composites of internationally recognised quality."
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The descriptions are for physical material testing.
How the ground truth for the training set was established:
- Not applicable.

Summary

{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)

Research Use (Per 21 CFR 361.2, Subpart B)
Over-The-Counter Use (21 CFR 361.2, Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/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, followed by the text 'DentsCare'. 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'.

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

{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

H) Substantial Equivalence:

The Llis, VITTRA APS is equivalent with the following products:

510(k) Number	Model	Company
K183476	3MTM ESPETM FiltekTMZ250 UniversalRestorative	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:- 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;	The Filtek™ Z250 Universal Restorative composite is suitable for use in:- Direct anterior and posterior restorations- Core buildups- Splinting- Indirect restorations including inlays, onlays and veneers

Intention of Use Comparison

Llis, VITTRA APS

3M™ ESPE™ Filtek™ Z250 Universal Restorative

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;

The Filtek™ Z250 Universal Restorative composite is suitable for use in:- Direct anterior and posterior restorations- Core buildups- Splinting- 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 andCommon Name	Llis, VITTRA APSDentscare	3M™ Filtek™ Z250 Universal Restorative3M 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 laboratoriesand clinics.Llis, VITTRA APS must be stored in temperaturesbetween 5° to 30°C	Dental prosthetics and authorized laboratories andclinics.3M™ ESPE™ Filtek™ Z250 Universal Restorativemust 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 orsubstances in contact withthe same human tissuesor body fluids?	YES	YES
Is the product incompliance to EN ISO10993 ?	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 sameclinical condition?	yes	yes
Is it used at the same sitein the body?	yes	yes
Is it used in a similarpopulation?	yes	yes
Is it used for the sameintended purpose?	yes	yes
Is not foreseen to deliversignificantly differentperformances?	no	no
Is it similar conditions ofuse?	yes	yes
Is it similar specificationsand properties	yes	yes
Is it similar principles ofoperation?	yes	yes

CLINICAL STEP	LLis and Vitra APS (FGM)	Z250 (3M ESPE)
Two options: total damisolation or relativeisolation	YES	YES
Application according toadhesive technique	YES	YES
Size for increments	1,5-2mm	2-2,5mm
Lightcuring unit	POWER $\geq$ 450mW/cm2 and WAVELENGTH OF400-500nm	POWER $\geq$ 400mW/cm2 and WAVELENGTH OF 400-500nm
Require finishing andpolishing	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 attestedany difference of color	The observers do not attestedany difference of color	The observers do not attested anydifference 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 toenvironmentlighting - ISO4049	According to the ISO 4049standard, acceptance is related tothe physical homogeneity of thesample, so the material wascompared after the test to thesame material pressed betweencoverslips, but without exposure toambient light. Thus, there is nodifference between the samples.	All results are within the range specifiedby ISO 4049.	ATTACHMENT 01- SENSITIVITY TOENVIRONMENTLIGHTING
Depth of Cure -ISO 4049	According to ISO 4049, thespecification for this material isthat its curing depth is: > 1.0 mmfor opaque materials and > 1.5mm for non-opaque materials.	All results are greater than the specifiedthreshold, therefore the material isconsidered to be in conformity.	ATTACHMENT 02 -DEPTH OF CURE
Colour tonestability afterradiation andwaterabsorption -ISO 4049 andISO 7491	The acceptance must beperformed provided that there isno more than a small change incolor, it must be proven as follows:a) comparisons should bemade by visual inspection andanalysed by three observers withnormal vision, who do not identifyany differences in color, thiscomparison must be carried at adistance of 200 to 300 mm for aperiod of no more than 2 seconds;b) perform the comparisoncited in a) in a light chamber atDay Light - D65 mode;c) perform the comparison inparagraph a), by placing thespecimen on a diffuse whitebackground of 90% approximatereflectance, and it should have asa limiting size the size of thespecimen, which must besurrounded by a grey backgroundwith a diffuse reflectance of 30 ±5%.	All comparisons were carried out bythree observers with normal eyesight(Tiago Vicente, Josley Habinzeureuterand Simone Brasil Carvalho), certifiedby a competent physician. They did notattest to any color difference in thesamples analyzed.The results demonstrate that theproduct meets ISO 4049.	ATTACHMENT 03 -COLOR TONESTABILITY AFTERRADIATION ANDWATERABSORPTION
Radiopacity -ISO 4049	Compare the individual opticaldrives of each aluminium scaleagainst the density of each scale(this check must be performedusing ISO 4049 as reference). Getthe value of the opticaldensity/grey value for the δsthickness of the specimen anddetermine the correspondingvalue of aluminium, δα.	The values found in the specimens arebetween the second and third scale ofthe aluminum part, proving that thematerial is radiolucent according to therequirements of ISO 4049	ATTACHMENT 04 -RADIOPACITY
FlexingResistance -ISO 4049	According to the EN ISO 4049standard the specification forflexural strength is ≥80MPa.	All results are greater than the specifiedthreshold, therefore the material isconsidered as conformant.	ATTACHMENT 05 -FLEXINGRESISTANCE
Water sorptionand solubility.- ISO 4049	Sorption: Maximum of 40 µm/mm³.Solubility: maximum of 7.5μm/mm³.	The results demonstrate that theproduct complies the specification in theEN ISO 4049 Standard.	ATTACHMENT 06 -WATER SORPTIONAND SOLUBILITY
AcceleratedStability Studies	Study created to accelerate thepossible chemical degradationand/or physical changes of theproduct in forced conditions ofstorage.	Considering the results observed at theend of the 274 days test period, theshelf-life of 3 years in the storagecondition of 30 °C for the product can beconfirmed.	ATTACHMENT 07 -ACCELERATEDSTABILITY STUDIES
EvaluationReport Of Long-Term Stability(Shelf)	Study designed to verify thephysical and chemicalcharacteristics of the productduring the expected shelf life. Theresults are used to confirm theexpiration date and storageconditions.	Considering the results observed at theend of the 36 months of the long-termtest (shelf), the shelf life of 3 years inthe storage condition of 30°C for theproduct can be confirmed.	ATTACHMENT 08 -EVALUATIONREPORT OF LONG-TERM STABILITY(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 toenvironment lighting– ISO 4049	According to the ISO 4049 standard,acceptance is related to the physicalhomogeneity of the sample, so thematerial was compared after the testto the same material pressed betweencoverslips, but without exposure toambient light. Thus, there is nodifference between the samples.	All results are within the rangespecified by ISO 4049.	ATTACHMENT 09 –SENSITIVITY TOENVIRONMENTLIGHTING
Depth of Cure - ISO4049	According to ISO 4049, thespecification for this material is that itscuring depth is: > 1.0 mm for opaquematerials and > 1.5 mm for non-opaque materials.	All results are greater than thespecified threshold, thereforethe material is considered tobe in conformity.	ATTACHMENT 10 –DEPTH OF CURE
Colour tone stabilityafter radiation andwater absorption -ISO 4049	The acceptance must be performedprovided that there is no more than asmall change in color, it must beproven as follows:a) comparisons should be madeby visual inspection and analysed bythree observers with normal vision,who do not identify any differences incolor, this comparison must be carriedat a distance of 200 to 300 mm for aperiod of no more than 2 seconds;b) perform the comparison citedin a) in a light chamber at Day Light -D65 mode;c) perform the comparison inparagraph a), by placing the specimenon a diffuse white background of 90%approximate reflectance, and it shouldhave as a limiting size the size of thespecimen, which must be surroundedby a grey background with a diffusereflectance of 30 ± 5%.	All comparisons were carriedout by three observers withnormal eyesight (TiagoVicente, JosleyHabinzeureuter and SimoneBrasil Carvalho), certified by acompetent physician. Theydid not attest to any colordifference in the samplesanalyzed.The results demonstrate thatthe product meets ISO 4049.	ATTACHMENT 11 -COLOUR TONESTABILITY AFTERRADIATION ANDWATERABSORPTION.
Radiopacity - ISO4049	Compare the individual optical drivesof each aluminium scale against thedensity of each scale (this check mustbe performed using ISO 4049 asreference). Get the value of the opticaldensity/grey value for the δs thicknessof the specimen and determine thecorresponding value of aluminium, δa.	The values found in thespecimens are between thesecond and third scale of thealuminum part, proving thatthe material is radiolucentaccording to the requirementsof ISO 4049	ATTACHMENT 12 -RADIOPACITY
Flexing Resistance -ISO 4049	According to the EN ISO 4049standard the specification for flexuralstrength is ≥80MPa.	All results are greater than thespecified threshold, thereforethe material is considered asconformant.	ATTACHMENT 13 -FLEXINGRESISTANCE
Water sorption andsolubility.- ISO 4049	Sorption: Maximum of 40 µm/mm³.Solubility: maximum of 7.5 µm/mm³.	The results demonstrate that theproduct complies thespecification in the EN ISO4049 Standard.	ATTACHMENT 14 -WATER SORPTIONAND SOLUBILITY.
Accelerated StabilityStudies	Study created to accelerate thepossible chemical degradation and/orphysical changes of the product inforced conditions of storage.	Considering the resultsobserved at the end of the274 days test period, theshelf-life of 3 years in thestorage condition of 30 °C forthe product can be confirmed.	ATTACHMENT 15 -ACCELERATEDSTABILITY STUDIES
Evaluation Report OfLong-Term Stability	Study designed to verify the physicaland chemical characteristics of the	Considering the resultsobserved at the end of the 36	ATTACHMENT 16 -EVALUATION
(Shelf)	product during the expected shelf life.The results are used to confirm theexpiration date and storage conditions.	months of the long-term test(shelf), the shelf life of 3 yearsin the storage condition of30°C for the product can beconfirmed.	REPORT OF LONG-TERM STABILITY(SHELF)
Color change duringpolymerization -Study carried out atUniversidadeEstadual de PontaGrossa (UEPG) andUniversidade Federaldo Maranhão	A comparative analysis will be carriedout between commercial compositesof internationally recognised qualityand the composite under analysis. It isdefined that the acceptance criterionfor this test is if the composite understudy has a value statistically ≤ thanthe competing composites analysed.	Vittra APS showed the leastchange in color, being similarto the resins Estelite Quick(Tokuyama) and Filtek Z350XT (3M ESPE).	ATTACHMENT 17- COLOR CHANGEDURINGPOLYMERIZATION
Knoop hardnessStudy carried out atUniversidadeEstadual de PontaGrossa (UEPG) andUniversidade Federaldo Maranhão	A comparative analysis will be carriedout between commercial compositesof internationally recognised qualityand the composite under analysis. It isdefined that the acceptance criterionfor this test is if the composite understudy has a value statistically ≥ thanthe competing composites analysed.	Vittra APS showed greatersurface hardness among thecomposites that participatedin the trial, showing surprisingSuchvalues.hardnessoriginates in the quality,morphology and content ofthe loads used as well as inthe quality of the polymersformed and its integration withthose loads.	ATTACHMENT 18- KNOOPHARDNESS
Conversion rateStudy carried out atUniversidadeEstadual de PontaGrossa (UEPG) andUniversidade Federaldo Maranhão	A comparative analysis will be carriedout between commercial compositesof internationally recognised qualityand the composite under analysis. It isdefined that the acceptance criterionfor this test is if the composite understudy has a value statistically ≥ thanthe competing composites analysed.	APSVittrashowedaconversion degree statisticallyequal to the best results of theother materials under analysiswithin aconsideredandrange.Theexcellentmechanicalresultsdemonstratedareanevidence for that observation.	ATTACHMENT 19- CONVERSIONRATE
Elasticity ModuleStudy carried out atUniversidadeEstadual de PontaGrossa (UEPG) andUniversidade Federaldo Maranhão	A comparative analysis will be carriedout between commercial compositesof internationally recognised qualityand the composite under analysis. It isdefined that the acceptance criterionfor this test is if the composite understudy has a mean equal to or slightlyless than that of human dentin (10-15Gpa).	VittraAPSshowedanelasticity module superior tothe one of resins EsteliteQuick (Tokuyama Dental) andTetricN-Ceram(IvoclarVivadent), being compatible tothe lowest limiting value thatis attributed to the humandentine.	ATTACHMENT 20- ELASTICITYMODULE
CompressiveStrenghtStudy carried out at	A comparative analysis will be carriedout between commercial compositesof internationally recognised quality	It is noticeable that Vittra APSshowed compressive strengthstatistically equal to the best	ATTACHMENT 21– COMPRESSIVE
UniversidadeEstadual de PontaGrossa (UEPG) andUniversidade Federaldo Maranhão	and the composite under analysis. It isdefined that the acceptance criterionfor this test is if the composite understudy has a value statistically ≥ thanthe competing composites analysed.	results of the other materialsunder analysis.	STRENGTH
Flexural ResistanceISO 4049Study carried out atUniversidadeEstadual de PontaGrossa (UEPG) andUniversidade Federaldo Maranhão	According to the EN ISO 4049standard, the specification for flexuralstrength is ≥80MPa.	The result shows that VittraAPS has excellent bendingresistance,statisticallycomparable or superior toproducts already well knownin the market.	ATTACHMENT 22- FLEXURALRESISTANCE
Roughness beforeand after simulatedbrushing.Study carried out atUniversidadeEstadual de PontaGrossa (UEPG) andUniversidade Federaldo Maranhão	A comparative analysis will be carriedout between commercial compositesof internationally recognised qualityand the composite under analysis. It isdefined that the acceptance criterionfor this test is if the composite understudy has a value ≤ thancompeting composites analysed.	Vittra APS was the onlycomposite that did not showincrease in surface roughnessafter simulated brushing. Theresult demonstrates highresistance to abrasion andreflects the properties thatwere already expected due tothe high Knoop Hardnessvalue that the product has.From a practical point of view,it is noticeable that Vittra APSshowed an increase in thesmoothness of the product,which explains the longlasting maintenance of itsshine	ATTACHMENT 23- ROUGHNESSBEFORE ANDAFTERSIMULATEDBRUSHING.
Fracture Toughness.Study carried out atUniversidadeEstadual de PontaGrossa (UEPG) andUniversidade Federaldo Maranhão	A comparative analysis will be carriedout between commercial compositesof internationally recognised qualityand the composite under analysis. It isdefined that the acceptance criterionfor this test is if the composite understudy has a value statistically ≥ thanthe competing composites analysed.	Vittra APS showed fracturetoughness statistically equalto the best results of the othermaterials under analysis.	ATTACHMENT 24- FRACTURETOUGHNESS.

{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.

Regulation Number and Section

§ 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.