(216 days)
Not Found
No
The summary describes a dental composite material and its physical properties, with no mention of AI or ML.
Yes
The device, a composite resin, is used for direct and indirect dental restorations, which are aimed at restoring the function and aesthetics of damaged teeth. This constitutes a therapeutic intervention.
No
The device is a composite material used for direct and indirect dental restorations, core build-ups, and other dental procedures, not for diagnosing conditions.
No
The device description clearly indicates that the device is a physical composite material used for dental restorations, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are all related to direct and indirect dental restorations, core build-ups, splinting, veneers, and repairs within the oral cavity of a patient. These are procedures performed directly on or in the patient's body.
- Device Description: The device is described as a radiopaque composite for anterior and posterior restorations, composed of methacrylate monomers, silanes, and fillers. This is a material used for physical restoration of teeth.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes.
- Anatomical Site: The anatomical site is the oral cavity/teeth, which is part of the living patient.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the composite material itself (depth of cure, strength, water absorption, radiopacity, etc.) and its performance in simulated clinical conditions (simulated brushing). These are relevant to its use as a restorative material, not as a diagnostic tool.
IVD devices are specifically designed to be used in vitro to analyze samples like blood, urine, tissue, etc., to provide diagnostic information. This device is a restorative material used in vivo (within the living body) for structural and aesthetic purposes.
N/A
Intended Use / Indications for Use
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;
Product codes
EBF
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.
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 light-curing unit available on the market, even those with less power or narrow range of wavelength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental prosthetics and authorized laboratories and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing for Llis:
- Sensitivity to environment lighting - ISO 4049:
- Specification: Physical homogeneity of the sample; no difference between samples after comparison to material pressed between coverslips without ambient light exposure.
- Results: All results are within the range specified by ISO 4049. Material is considered conformant.
- Depth of Cure - ISO 4049:
- Specification: > 1.0 mm for opaque materials and > 1.5 mm for non-opaque materials.
- Results: All results are greater than the specified threshold, therefore the material is considered to be in conformity.
- Colour tone stability after radiation and water absorption - ISO 4049 and ISO 7491:
- Specification: No more than a small change in color, proven by visual inspection by three observers with normal vision in a D65 light chamber, on a white background (90% reflectance) surrounded by a grey background (30% ± 5% reflectance).
- Results: 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 - ISO 4049:
- Specification: Compare optical drives of aluminum scale with density of scale, determine corresponding value of aluminum.
- Results: 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.
- Flexing Resistance - ISO 4049:
- Specification: ≥80MPa.
- Results: All results are greater than the specified threshold, therefore the material is considered as conformant.
- Water sorption and solubility - ISO 4049:
- Specification: Sorption: Maximum of 40 µm/mm³. Solubility: maximum of 7.5 µm/mm³.
- Results: The results demonstrate that the product complies the specification in the EN ISO 4049 Standard.
- Accelerated Stability Studies:
- Specification: Study to accelerate possible chemical degradation and/or physical changes in forced storage conditions.
- Results: 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):
- Specification: Verify physical and chemical characteristics during expected shelf life to confirm expiration date and storage conditions.
- Results: 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.
Non-clinical Testing for VITTRA APS:
- Sensitivity to environment lighting – ISO 4049:
- Specification: Physical homogeneity of the sample after comparison to material pressed between coverslips without ambient light exposure.
- Results: All results are within the range specified by ISO 4049. Material is considered conformant.
- Depth of Cure - ISO 4049:
- Specification: > 1.0 mm for opaque materials and > 1.5 mm for non-opaque materials.
- Results: All results are greater than the specified threshold, therefore the material is considered to be in conformity.
- Colour tone stability after radiation and water absorption - ISO 4049:
- Specification: No more than a small change in color, proven by visual inspection by three observers with normal vision in a D65 light chamber, on a white background (90% reflectance) surrounded by a grey background (30% ± 5% reflectance).
- Results: 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 - ISO 4049:
- Specification: Compare individual optical drives of aluminum scale against density of scale; determine corresponding aluminum value.
- Results: 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.
- Flexing Resistance - ISO 4049:
- Specification: ≥80MPa.
- Results: All results are greater than the specified threshold, therefore the material is considered as conformant.
- Water sorption and solubility - ISO 4049:
- Specification: Sorption: Maximum of 40 µm/mm³. Solubility: maximum of 7.5 µm/mm³.
- Results: The results demonstrate that the product complies the specification in the EN ISO 4049 Standard.
- Accelerated Stability Studies:
- Specification: Study to accelerate possible chemical degradation and/or physical changes in forced storage conditions.
- Results: 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):
- Specification: Verify physical and chemical characteristics during expected shelf life to confirm expiration date and storage conditions.
- Results: 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.
- Color change during polymerization - Study carried out at Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão:
- Specification: Comparative analysis with commercial composites; acceptance criterion is composite value statistically ≤ competing composites.
- Results: Vittra APS showed the least change in color, being similar to the resins Estelite Quick (Tokuyama) and Filtek Z350 XT (3M ESPE).
- Knoop hardness Study carried out at Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão:
- Specification: Comparative analysis with commercial composites; acceptance criterion is composite value statistically ≥ competing composites.
- Results: Vittra APS showed greater surface hardness among the composites that participated in the trial, showing surprising Such values. hardness originates in the quality, morphology and content of the loads used as well as in the quality of the polymers formed and its integration with those loads.
- Conversion rate Study carried out at Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão:
- Specification: Comparative analysis with commercial composites; acceptance criterion is composite value statistically ≥ competing composites.
- Results: Vittra APS showed a conversion degree statistically equal to the best results of the other materials under analysis and considered within a range. The excellent mechanical results demonstrated are an evidence for that observation.
- Elasticity Module Study carried out at Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão:
- Specification: Comparative analysis with commercial composites; acceptance criterion is composite mean equal to or slightly less than human dentin (10-15 Gpa).
- Results: 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 Strenght Study carried out at Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão:
- Specification: Comparative analysis with commercial composites; acceptance criterion is composite value statistically ≥ competing composites.
- Results: It is noticeable that Vittra APS showed compressive strength statistically equal to the best results of the other materials under analysis.
- Flexural Resistance ISO 4049 Study carried out at Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão:
- Specification: ≥80MPa.
- Results: The result shows that Vittra APS has excellent bending resistance, statistically comparable or superior to products already well known in the market.
- Roughness before and after simulated brushing. Study carried out at Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão:
- Specification: Comparative analysis with commercial composites; acceptance criterion is composite value ≤ competing composites.
- Results: Vittra APS was the only composite that did not show increase in surface roughness after simulated brushing. The result demonstrates high resistance to abrasion and reflects the properties that were already expected due to the high Knoop Hardness value that the product has. From a practical point of view, it is noticeable that Vittra APS showed an increase in the smoothness of the product, which explains the long lasting maintenance of its shine.
- Fracture Toughness. Study carried out at Universidade Estadual de Ponta Grossa (UEPG) and Universidade Federal do Maranhão:
- Specification: Comparative analysis with commercial composites; acceptance criterion is composite value statistically ≥ competing composites.
- Results: Vittra APS showed fracture toughness statistically equal to the best results of the other materials under analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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)
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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
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 | |
| 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: |
- 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.
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Image /page/6/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, and the name 'DentsCare' written below. The contact information includes the 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
Common Name | Llis, VITTRA APS
Dentscare | 3M™ Filtek™ Z250 Universal Restorative
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
and clinics.
Llis, VITTRA APS must be stored in temperatures
between 5° to 30°C | Dental prosthetics and authorized laboratories and
clinics.
3M™ ESPE™ Filtek™ Z250 Universal Restorative
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
substances in contact with
the same human tissues
or body fluids? | YES | YES |
| Is the product in
compliance to EN ISO
10993 ? | YES | YES |
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Image /page/7/Picture/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter 'D' with 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 | ||
| clinical condition? | yes | yes |
| Is it used at the same site | ||
| in the body? | yes | yes |
| Is it used in a similar | ||
| population? | yes | yes |
| Is it used for the same | ||
| intended purpose? | yes | yes |
| Is not foreseen to deliver | ||
| significantly different | ||
| performances? | no | no |
| Is it similar conditions of | ||
| use? | yes | yes |
| Is it similar specifications | ||
| and properties | yes | yes |
| Is it similar principles of | ||
| operation? | yes | yes |
| CLINICAL STEP | LLis and Vitra APS (FGM) | Z250 (3M ESPE) |
|---|---|---|
| Two options: total dam | ||
| isolation or relative | ||
| isolation | YES | YES |
| Application according to | ||
| adhesive technique | YES | YES |
| Size for increments | 1,5-2mm | 2-2,5mm |
| Lightcuring unit | POWER $\geq$ 450mW/cm2 and WAVELENGTH OF | |
| 400-500nm | POWER $\geq$ 400mW/cm2 and WAVELENGTH OF 400- | |
| 500nm | ||
| Require finishing and | ||
| polishing | YES | YES |
| Specification | Llis | Vittra APS | Filtek TM Z250 Universal Restorative |
|---|---|---|---|
| Sensitivity to ambient light | physically homogeneous | physically homogeneous | physically homogeneous |
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Image /page/8/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with 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 | ||
| any difference of color | The observers do not attested | ||
| any difference of color | The observers do not attested any | ||
| 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 | |||
| environment | |||
| lighting - ISO | |||
| 4049 | According to the ISO 4049 | ||
| standard, acceptance is related to | |||
| the physical homogeneity of the | |||
| sample, so the material was | |||
| compared after the test to the | |||
| same material pressed between | |||
| coverslips, but without exposure to | |||
| ambient light. Thus, there is no | |||
| difference between the samples. | All results are within the range specified | ||
| by ISO 4049. | ATTACHMENT 01 |
- SENSITIVITY TO
ENVIRONMENT
LIGHTING |
| Depth of Cure -
ISO 4049 | According to ISO 4049, the
specification for this material is
that its curing depth is: > 1.0 mm
for opaque materials and > 1.5
mm for non-opaque materials. | All results are greater than the specified
threshold, therefore the material is
considered to be in conformity. | ATTACHMENT 02 -
DEPTH OF CURE |
| Colour tone
stability after
radiation and
water
absorption -
ISO 4049 and
ISO 7491 | The acceptance must be
performed provided that there is
no more than a small change in
color, it must be proven as follows:
a) comparisons should be
made by visual inspection and
analysed by three observers with
normal vision, who do not identify
any differences in color, this
comparison must be carried at a
distance of 200 to 300 mm for a
period of no more than 2 seconds;
b) perform the comparison
cited in a) in a light chamber at
Day Light - D65 mode;
c) perform the comparison in
paragraph a), by placing the
specimen on a diffuse white
background of 90% approximate
reflectance, and it should have as
a limiting size the size of the
specimen, which must be
surrounded by a grey background
with a diffuse reflectance of 30 ±
5%. | 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. | ATTACHMENT 03 -
COLOR TONE
STABILITY AFTER
RADIATION AND
WATER
ABSORPTION |
| Radiopacity -
ISO 4049 | Compare the individual optical
drives of each aluminium scale
against the density of each scale
(this check must be performed
using ISO 4049 as reference). Get
the value of the optical
density/grey value for the δs
thickness of the specimen and
determine the corresponding
value of aluminium, δα. | 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 | ATTACHMENT 04 -
RADIOPACITY |
| Flexing
Resistance -
ISO 4049 | According to the EN ISO 4049
standard the specification for
flexural strength is ≥80MPa. | All results are greater than the specified
threshold, therefore the material is
considered as conformant. | ATTACHMENT 05 -
FLEXING
RESISTANCE |
| Water sorption
and solubility. - ISO 4049 | Sorption: Maximum of 40 µm/mm³.
Solubility: maximum of 7.5
μm/mm³. | The results demonstrate that the
product complies the specification in the
EN ISO 4049 Standard. | ATTACHMENT 06 -
WATER SORPTION
AND SOLUBILITY |
| Accelerated
Stability Studies | Study created to accelerate the
possible chemical degradation
and/or physical changes of the
product in forced conditions of
storage. | 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. | ATTACHMENT 07 -
ACCELERATED
STABILITY STUDIES |
| Evaluation
Report Of Long-
Term Stability
(Shelf) | Study designed to verify the
physical and chemical
characteristics of the product
during the expected shelf life. The
results are used to confirm the
expiration date and storage
conditions. | 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. | ATTACHMENT 08 -
EVALUATION
REPORT 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 to | |||
| environment lighting | |||
| – ISO 4049 | According to the ISO 4049 standard, | ||
| acceptance is related to the physical | |||
| homogeneity of the sample, so the | |||
| material was compared after the test | |||
| to the same material pressed between | |||
| coverslips, but without exposure to | |||
| ambient light. Thus, there is no | |||
| difference between the samples. | All results are within the range | ||
| specified by ISO 4049. | ATTACHMENT 09 – | ||
| SENSITIVITY TO | |||
| ENVIRONMENT | |||
| LIGHTING | |||
| Depth of Cure - ISO | |||
| 4049 | According to ISO 4049, the | ||
| specification for this material is that its | |||
| curing depth is: > 1.0 mm for opaque | |||
| materials and > 1.5 mm for non- | |||
| opaque materials. | All results are greater than the | ||
| specified threshold, therefore | |||
| the material is considered to | |||
| be in conformity. | ATTACHMENT 10 – | ||
| DEPTH OF CURE | |||
| Colour tone stability | |||
| after radiation and | |||
| water absorption - | |||
| ISO 4049 | The acceptance must be performed | ||
| provided that there is no more than a | |||
| small change in color, it must be | |||
| proven as follows: |
a) comparisons should be made
by visual inspection and analysed by
three observers with normal vision,
who do not identify any differences in
color, this comparison must be carried
at a distance of 200 to 300 mm for a
period of no more than 2 seconds;
b) perform the comparison cited
in a) in a light chamber at Day Light -
D65 mode;
c) perform the comparison in
paragraph a), by placing the specimen
on a diffuse white background of 90%
approximate reflectance, and it should
have as a limiting size the size of the
specimen, which must be surrounded
by a grey background with a diffuse
reflectance of 30 ± 5%. | 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. | ATTACHMENT 11 -
COLOUR TONE
STABILITY AFTER
RADIATION AND
WATER
ABSORPTION. |
| Radiopacity - ISO
4049 | Compare the individual optical drives
of each aluminium scale against the
density of each scale (this check must
be performed using ISO 4049 as
reference). Get the value of the optical
density/grey value for the δs thickness
of the specimen and determine the
corresponding value of aluminium, δa. | 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 | ATTACHMENT 12 -
RADIOPACITY |
| Flexing Resistance -
ISO 4049 | According to the EN ISO 4049
standard the specification for flexural
strength is ≥80MPa. | All results are greater than the
specified threshold, therefore
the material is considered as
conformant. | ATTACHMENT 13 -
FLEXING
RESISTANCE |
| Water sorption and
solubility.
- ISO 4049 | Sorption: Maximum of 40 µm/mm³.
Solubility: maximum of 7.5 µm/mm³. | The results demonstrate that the
product complies the
specification in the EN ISO
4049 Standard. | ATTACHMENT 14 -
WATER SORPTION
AND SOLUBILITY. |
| Accelerated Stability
Studies | Study created to accelerate the
possible chemical degradation and/or
physical changes of the product in
forced conditions of storage. | 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. | ATTACHMENT 15 -
ACCELERATED
STABILITY STUDIES |
| Evaluation Report Of
Long-Term Stability | Study designed to verify the physical
and chemical characteristics of the | Considering the results
observed at the end of the 36 | ATTACHMENT 16 -
EVALUATION |
| (Shelf) | product during the expected shelf life.
The results are used to confirm the
expiration date and storage conditions. | 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. | REPORT OF LONG-
TERM STABILITY
(SHELF) |
| Color change during
polymerization -
Study carried out at
Universidade
Estadual de Ponta
Grossa (UEPG) and
Universidade Federal
do Maranhão | A comparative analysis will be carried
out between commercial composites
of internationally recognised quality
and the composite under analysis. It is
defined that the acceptance criterion
for this test is if the composite under
study has a value statistically ≤ than
the competing composites analysed. | Vittra APS showed the least
change in color, being similar
to the resins Estelite Quick
(Tokuyama) and Filtek Z350
XT (3M ESPE). | ATTACHMENT 17
- COLOR CHANGE
DURING
POLYMERIZATION |
| Knoop hardness
Study carried out at
Universidade
Estadual de Ponta
Grossa (UEPG) and
Universidade Federal
do Maranhão | A comparative analysis will be carried
out between commercial composites
of internationally recognised quality
and the composite under analysis. It is
defined that the acceptance criterion
for this test is if the composite under
study has a value statistically ≥ than
the competing composites analysed. | Vittra APS showed greater
surface hardness among the
composites that participated
in the trial, showing surprising
Such
values.
hardness
originates in the quality,
morphology and content of
the loads used as well as in
the quality of the polymers
formed and its integration with
those loads. | ATTACHMENT 18 - KNOOP
HARDNESS |
| Conversion rate
Study carried out at
Universidade
Estadual de Ponta
Grossa (UEPG) and
Universidade Federal
do Maranhão | A comparative analysis will be carried
out between commercial composites
of internationally recognised quality
and the composite under analysis. It is
defined that the acceptance criterion
for this test is if the composite under
study has a value statistically ≥ than
the competing composites analysed. | APS
Vittra
showed
a
conversion degree statistically
equal to the best results of the
other materials under analysis
within a
considered
and
range.
The
excellent
mechanical
results
demonstrated
are
an
evidence for that observation. | ATTACHMENT 19 - CONVERSION
RATE |
| Elasticity Module
Study carried out at
Universidade
Estadual de Ponta
Grossa (UEPG) and
Universidade Federal
do Maranhão | A comparative analysis will be carried
out between commercial composites
of internationally recognised quality
and the composite under analysis. It is
defined that the acceptance criterion
for this test is if the composite under
study has a 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. | ATTACHMENT 20 - ELASTICITY
MODULE |
| Compressive
Strenght
Study carried out at | A comparative analysis will be carried
out between commercial composites
of internationally recognised quality | It is noticeable that Vittra APS
showed compressive strength
statistically equal to the best | ATTACHMENT 21
– COMPRESSIVE |
| Universidade
Estadual de Ponta
Grossa (UEPG) and
Universidade Federal
do Maranhão | and the composite under analysis. It is
defined that the acceptance criterion
for this test is if the composite under
study has a value statistically ≥ than
the competing composites analysed. | results of the other materials
under analysis. | STRENGTH |
| Flexural Resistance
ISO 4049
Study carried out at
Universidade
Estadual de Ponta
Grossa (UEPG) and
Universidade Federal
do Maranhão | According to the EN ISO 4049
standard, the specification for flexural
strength is ≥80MPa. | The result shows that Vittra
APS has excellent bending
resistance,
statistically
comparable or superior to
products already well known
in the market. | ATTACHMENT 22 - FLEXURAL
RESISTANCE |
| Roughness before
and after simulated
brushing.
Study carried out at
Universidade
Estadual de Ponta
Grossa (UEPG) and
Universidade Federal
do Maranhão | A comparative analysis will be carried
out between commercial composites
of internationally recognised quality
and the composite under analysis. It is
defined that the acceptance criterion
for this test is if the composite under
study has a value ≤ than
competing composites analysed. | Vittra APS was the only
composite that did not show
increase in surface roughness
after simulated brushing. The
result demonstrates high
resistance to abrasion and
reflects the properties that
were already expected due to
the high Knoop Hardness
value that the product has.
From a practical point of view,
it is noticeable that Vittra APS
showed an increase in the
smoothness of the product,
which explains the long
lasting maintenance of its
shine | ATTACHMENT 23 - ROUGHNESS
BEFORE AND
AFTER
SIMULATED
BRUSHING. |
| Fracture Toughness.
Study carried out at
Universidade
Estadual de Ponta
Grossa (UEPG) and
Universidade Federal
do Maranhão | A comparative analysis will be carried
out between commercial composites
of internationally recognised quality
and the composite under analysis. It is
defined that the acceptance criterion
for this test is if the composite under
study has a value statistically ≥ than
the competing composites analysed. | Vittra APS showed fracture
toughness statistically equal
to the best results of the other
materials under analysis. | ATTACHMENT 24 - FRACTURE
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.