(277 days)
Allcem Veneer APS is an adhesive luting of ceramic and composite restorations (fabricated at the chair-side or in the laboratory) with a low layer thickness (up to 1.5 mm) that enable the use of a purely light-curing technique due to their high translucency.
Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement.
Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thickness, that do not have opaque infrastructure. The cement is presented as a single component (single svringe) and must be used according to the adhesive cementation technique (acid etching + adhesive).
APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photo initiators that interact among each other amplifying the curing capacity of light emitted from light-curing units.
Presentation Form:
- syringe (2,5g) of Allcem Veneer APS cement in shade A1
- syringe (2,5q) of Allcem Veneer APS cement in shade A2
- syringe (2,5g) of Allcem Veneer APS cement in shade A3
- syringe (2,5q) of Allcem Veneer APS cement in shade Trans (Translucent)
- syringe (2,5q) of Allcem Veneer APS cement in shade Opaque
- syringe (2,5q) of Allcem Veneer APS cement in shade White
- syringe (2,5q) of Allcem Veneer APS cement in shades E-Bleach M
- syringes (2g) of Try-in
This document is a 510(k) premarket notification for a dental resin material, Allcem Veneer APS. The information provided describes the device's technical characteristics and performance compared to a predicate device (Variolink® Esthetic) to demonstrate substantial equivalence, rather than a clinical study evaluating an AI/ML powered device.
Therefore, many of the requested elements for an AI/ML device study (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or training set details) are not applicable or not provided in this document.
However, I can extract information related to the acceptance criteria for the material properties and the reported performance of the device based on established international standards.
Here's a breakdown of the requested information based on the provided text, focusing on the material's performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Specification) | Reported Device Performance (Allcem Veneer APS) | Reported Predicate Performance (Variolink® Esthetic) |
|---|---|---|---|
| Film Thickness | ≤ 50 µm (and not 10 µm above manufacturer's declared value if declared, but wasn't for Allcem Veneer APS) - ISO 4049 | Average: 11.8 µm (Samples: 17, 15, 13, 9, 5 µm) | Average: 22.0 µm (Samples: 25, 18, 27, 20, 20 µm) |
| Stability of Tone and Color | No more than a small change in color; visual inspection by three observers with normal vision, identifying no differences - ISO 4049 | All comparisons by three observers with normal eyesight showed no color difference. | Observers attest no difference of color (implied to meet criteria). |
| Flexural Strength | ≥ 50 MPa - EN ISO 4049 | 110.90 MPa | 91.84 MPa |
| Depth of Cure | > 1.0 mm for opaque materials; > 1.5 mm for non-opaque materials - ISO 4049 | All results were greater than specified threshold (e.g., 2.19 mm reported in comparison; detailed CP results not provided for Allcem Veneer APS in table). | 1.62 mm (reported in comparison table) |
| Radiopacity | ≥ 1 mm (aluminum equivalent for 1.0 mm thick specimen); not 0.5 mm above manufacturer's declared value if declared - ISO 4049 (material must be radiopaque if declared) | 2.47 mm | 2.36 mm |
| Sensitivity to Environment Lighting | Physical homogeneity of the sample (no difference after test compared to unexposed sample) - ISO 4049 | Superior to the acceptance criteria (> 60 sec). | Superior to the acceptance criteria (implied to meet). |
| Water Sorption and Solubility | Sorption: ≤ 40 µg/mm³; Solubility: ≤ 7.5 µg/mm³ - EN ISO 4049 | Sorption: 24.46 µg/mm³; Solubility: 6.17 µg/mm³ | Sorption: 25.61 µg/mm³; Solubility: 5.27 µg/mm³ |
| Accelerated Stability Studies | Confirm 2-year shelf-life at 25 °C. | 2-year shelf-life at 25 °C confirmed based on 129 days of testing. | Not applicable (device under evaluation). |
| Long-Term Stability (Shelf) Report | Verify physical and chemical characteristics over expected shelf life. | Maintains properties for 2 years in indicated storage condition. | Not applicable (device under evaluation). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the total number of samples or specimens used for each test. For Film Thickness, 5 samples were listed for both Allcem Veneer APS and Variolink. Other tests refer to "results" or "specimens" without specific counts.
- Data Provenance: The studies were conducted by the manufacturer, Dentscare Ltda, based in Brazil (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL). The studies are non-clinical (laboratory-based) performance tests, not retrospective or prospective clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- For the "Stability of tone and color" test, three observers with normal vision, certified by a competent physician, were used for visual inspection.
- For other tests, the "ground truth" is defined by the ISO 4049 standard and measured by laboratory equipment, not human experts.
4. Adjudication Method for the Test Set:
- For the "Stability of tone and color" test, the judgment was based on consensus (implicitly, as "no color difference... attested" by all three observers).
- For other material property tests, adjudication methods are not applicable as they are objective laboratory measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This document pertains to the
substantial equivalence of a dental resin material based on mechanical and chemical properties, not a reader-dependent diagnostic AI/ML device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental material, not an algorithm. The performance tests are for the material itself.
7. The type of ground truth used:
- The "ground truth" for the device's performance is established by objective measurements against the specifications outlined in international standards, primarily ISO 4049 (Dentistry Polymer-based restorative materials) and ISO 10993-1 (Biological evaluation of medical devices). For color stability, it's expert consensus (three observers).
8. The sample size for the training set:
- Not applicable. This is a physical dental material, not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, this question is irrelevant.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 25, 2020
Dentscare Ltda % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K191389
Trade/Device Name: Allcem Veneer APS Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: November 25, 2019 Received: November 27, 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
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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 "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191389
Device Name Allcem Veneer APS
Indications for Use (Describe)
Allcem Veneer APS is an adhesive luting of ceramic and composite restorations (fabricated at the chair-side or in the laboratory) with a low layer thickness (up to 1.5 mm) that enable the use of a purely light-curing technique due to their high translucency.
Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo and contact information for Dentscare Ltda. The logo features a stylized letter D with horizontal lines inside. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
510(k) SUMMARY
- A) Submitter's Name: DENTSCARE LTDA Owner / Operator Registration Number: 3007210751 Manufacture Registration Number: 3007210751
- B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL
- C) Phone and Fax Numbers
Phone: +55 (47) 34416131
- D) Contact Person: Roberta Uyara Tel.: +55 (47) 34416131 Email: roberta.uvara@fam.ind.br
- E) Date of the most recent revision: February 24, 2020
- F) Classification Name: Material, Tooth Shade, Resin
Common / Usual Name: Material, Tooth Shade, Resin
Proprietary Name: Allcem Veneer APS
Product Code: EBF Class: Class II Regulation: 21 CFR 872.3690
- G) Device Description
ALLCEM VENEER APS
Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thickness, that do not have opaque infrastructure. The cement is presented as a single component (single svringe) and must be used according to the adhesive cementation technique (acid etching + adhesive).
APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photo initiators that interact among each other amplifying the curing capacity of light emitted from light-curing units.
Presentation Form:
- syringe (2,5g) of Allcem Veneer APS cement in shade A1 ●
- . syringe (2,5q) of Allcem Veneer APS cement in shade A2
- syringe (2,5g) of Allcem Veneer APS cement in shade A3 ●
- . syringe (2,5q) of Allcem Veneer APS cement in shade Trans (Translucent)
- . syringe (2,5q) of Allcem Veneer APS cement in shade Opaque
- . syringe (2,5q) of Allcem Veneer APS cement in shade White
- syringe (2,5q) of Allcem Veneer APS cement in shades E-Bleach M .
- . syringes (2g) of Try-in
H) Substantial Equivalence:
The Allcem Veneer APS is equivalent with the following products:
| 510(k) Number | Model | Company |
|---|---|---|
| K142389 | Variolink® Esthetic | Ivoclar Vivadent, AG |
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Image /page/4/Picture/1 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with three horizontal lines inside. The text includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
Page 2 of 8
I) Indications for Use:
| Indications for Use Comparison | |
|---|---|
| Allcem Veneer APS | Variolink® Esthetic |
| Allcem Veneer APS is an adhesive luting of ceramicand composite restorations (fabricated at the chair-side or in the laboratory) with a low layer thickness(up to 1.5 mm) that enable the use of a purelylight-curing technique due to their hightranslucency.Allcem Veneer Try-in accessory is used to simulatethe chromatic effect that will be provided whenselected the ideal color of Allcem Veneer cement. | Variolink Esthetic LC:– Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramicand composite restorations (inlays, onlays and veneers)– Only use Variolink Esthetic LC for restorations with a low thickness of <2mmthat have sufficient translucency (e.g. restorations made of IPS e.max R HT).Variolink Esthetic DC:– Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic andcompositemrestorations (inlays, onlays, partial crowns, bridges).– Restorations made of opaque ceramics, e.g. oxide ceramics, can only bepermanently cemented if an adhesive is additionally used that is separatelylight-cured.Variolink Esthetic Try-In:To evaluate the overall effect of the restoration in conjunction with the variousVariolink Esthetic shades prior to permanent cementation. |
Allcem Venner APS is a light-cured resin cementation of ceramic and composite restorations with a low layer thickness (up to 1.5 mm) that does not have an opaque infrastructure. The predicate model that the subject device demonstrates equivalence to is the Variolink Esthetic LC version has a similar indication of use only for restorations (ceramic and composite) with a low thickness <2mm that have sufficient translucency. The difference between products is the thickness indicated, our product has more restricted range, assuring the high of the procedure. This slight difference that does not impact the subject device, considering all the other similarities.
Regarding the accessory product, both have the same indication of use, that is to simulate the color of the restoration before the use of the permanent cement (Allcem Veneer APS/Variolink Esthetic LC).
J) Technological Characteristics Comparison:
The predicate device used to establish substantial equivalence for the Allcem is outlined below. This section of this submission will provide a comparison of dechnical specifications of the Alcem Veneer APS to each of the predicate devices stratified by functional modality.
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Image /page/5/Picture/0 description: The image shows the alphanumeric string "K191389" in a bold, sans-serif font. The characters are black against a white background. The string appears to be a code or identifier, possibly a serial number or product code.
Image /page/5/Picture/1 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 address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
Page 3 of 8
| Device Manufacturer and Common | Allcem Veneer APS | Variolink® Esthetic |
|---|---|---|
| Name | Dentscare | Ivoclar Vivadent, AG |
| 510k # | K191389 | K142389 |
| Classification | Class II | Class II |
| Regulation # | 21 CFR 872.3690 | 21 CFR 872.3690 |
| Product Code | EBF | EBF |
| Classification Name | Material, Tooth Shade, Resin | Material, Tooth Shade, Resin |
| Patient Population | Adults | Adults |
| Prescription Use | RX only | RX only |
| EnvironmentStorage Environment | Dental prosthetics and authorized laboratories andclinics.5° to 25°C | Dental prosthetics and authorized laboratories andclinics.2-28 °C/36-82 °F |
| Applicable Standards | ISO 4049 ; ISO 10993-1 | ISO 4049 ; ISO 10993-1 |
| Base Composition | Methacrylate Monomers, camphorquinone, co-initiators, pigments, Barium-Aluminum-silicatesalinized glass particles and silicon dioxide. | The monomer of Variolink Esthetic is composed ofurethane dimethacrylate and further methacrylatemonomers. The inorganic fillers are ytterbiumtrifluoride and spheroid mixed oxide. Initiators,stabilizers and pigments are additional ingredients. |
| Device Sterilization | Not Applicable | Not Applicable |
| Primary Package Container : | Syringe | Syringe |
| Shelf life | 2 years | Not declared |
| Use the same materials orsubstances in contact with thesame human tissuesor body fluids? | YES | YES |
| Is the product in compliance toEN ISO 10993 ? | YES | YES |
| Tissues | Enamel and Dentin | Enamel and Dentin |
| Reusable | NO | NO |
| Duration | Permanent | Permanent |
| Part of body | Oral, tooth | Oral, tooth |
| Is it used for the same clinicalcondition? | yes | yes |
| Is it used at the same site in thebody? | yes | yes |
| Is it used in a similar population? | yes | yes |
| Is it used for the same intendedpurpose? | yes | yes |
| Is not foreseen to deliversignificantly differentperformances? | no | no |
| Is it similar conditions of use? | yes | yes |
| Is it similar specifications andproperties | yes | yes |
| Is it similar principles of operation? | yes | yes |
| Film Thickness | 11.8 µm | 22.0 µm |
| Stability of tone and colour - ISO4049 | The observers do not attest any difference of colour | The observers do not attest any difference ofcolour |
| Flexural Strength - ISO 4049 | 110.90 MPa | 91.84 MPa |
| Depth of Cure- ISO 4049 | 2.19 mm | 1.62 mm |
| Radiopacity- ISO 4049 | 2.47 mm | 2.36 mm |
| Sensitivity to environment lighting | Present a Sensitivity to environment lighting superior tothe acceptance criteria. | Present a Sensitivity to environment lightingsuperior to the acceptance criteria. |
| Water sorption and solubility - ISO4049 | Sorption: 24.46 µg/mm3Solubility: 6.17 µg/mm³ | Sorption: 25.61 µg/mm3Solubility: 5.27 µg/mm³ |
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Image /page/6/Picture/1 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).
Page 4 of 8
MODE OF USE
| CLINICAL STEP | Allcem Veneer APS (DENTSCARE) | Variolink® Esthetic |
|---|---|---|
| TWO OPTIONS: TOTAL DAM ISOLATION ORRELATIVE ISOLATION | YES | YES |
| APPLICATION ACCORDING TO ADHESIVETECHNIQUE | YES | YES |
| SIZE FOR INCREMENTS | Up to 1.5mm | Up to 2mm |
| LIGHTCURING UNIT | POWER ≥ 450mW/cm² and WAVELENGTH OF400-500nm | POWER ≥ 500mW/cm2 and WAVELENGTH OF400-500nm |
| REQUIRE FINISHING AND POLISHING | YES | YES |
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Image /page/7/Picture/1 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with horizontal lines inside, and the text "DentsCare" is written below it. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-5 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
Substantial Equivalence Discussion:
The subject device is similar to the predicate devices in that they are all resin cement for adhesive cementation of ceramic and composite resin restorations.
Despite differences in comparison, the subject device demonstrates substantial equivalence to the declared predicate, since all products meet ISO 4049 and the results match the requirements of this International Standard and it does not affect the substantial equivalence.
-
Film thickness: As the individual results as the average result for film thickness of the subject device are no greater than 50 um (according to the ISO 4049 standard). The predicate device also meets the ISO 4049, and the subject device shows substantial equivalence to the predicate device.
-
Stability of tone and color: Both products do not attest any difference of color, being in accordance to ISO 4049.
-
Flexural strength: The average of the results of Allcem Veneer APS is ≥ the average of the predicate device analyzed in the study. By the results obtained, the subject device demonstrates substantial equivalence to the predicate device.
-
Depth of cure: The average of the results of Allcem Veneer APS is > the average of the predicate device analyzed in the study. By the results obtained, all the products analyzed presented satisfactory results in accordance to ISO 4049, and the subject device demonstrates substantial equivalence to the predicate device.
-
Radiopacity: The average results found for both products are similar, demonstrating similar radiopacity characteristics between products.
Sensitivity to environment lighting: Both products have demonstrated physical i homogeneity when initial samples were compared with samples that were exposed to radiation.
- Water sorption and solubility: The results show that the subject device presented Sorption and Solubility similar to the competing product under analysis.
Conclusion: From the comparison results obtained, the subject device Allcem Venner APS demonstrates equivalence with the predicate device, since both meet ISO 4049 and both have similar technological and intentions for use.
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Image /page/8/Picture/1 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 address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
K) Applicable Standards:
In order to reach substantially equivalent to the predicate device, the device Allcem Veneer 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 (EN ISO 10993-1:2009)
Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device Allcem Veneer APS demonstrate equivalency to the predicate above, once both products are in compliance to ISO 4049 and there is no statistical difference among the materials, assuring equivalence between the composites.
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 summary below.
| Test | Specification | Results |
|---|---|---|
| Sensitivitytoenvironmentlighting –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. | Present a Sensitivity to environment lighting superior to the acceptance criteria (> 60 sec). |
| Depth ofCure - ISO4049 | 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. |
| Specimen(mm) | ||
| CP 1 | ||
| CP 2 | ||
| CP 3 | ||
| Average: | ||
| Color tonestabilityafterradiationand waterabsorption -ISO 4049 | The acceptance must be performed providedthat there is no more than a small change incolour, it must be proven as follows:a) comparisons should be made by visualinspection and analyzed by three observers withnormal vision, who do not identify anydifferences in colour, this comparison must becarried at a distance of 200 to 300 mm for aperiod of no more than 2 seconds;b) perform the comparison cited in a) in alight chamber at Day Light - D65 mode;c) perform the comparison in paragrapha), by placing the specimen on a diffuse whitebackground of 90% approximate reflectance,and it should have as a limiting size the size ofthe specimen, which must be surrounded by agrey background with a diffuse reflectance of30 ± 5%. | All comparisons were carried outby three observers with normaleyesight and certified by acompetent physician. Any colordifference in the samplesanalyzed were attested.The results demonstrate that theproduct meets ISO 4049. |
| Flexuralstrength | According to the EN ISO 4049 standard thespecification for flexural strength is ≥50MPa. | All results are greater than thespecified threshold, therefore thematerial is considered to be inconformityAllcem Veneer APS: 110.90 MPaVariolink: 91.84 MPa |
| FilmThickness. | According to the EN ISO 4049 standard the filmthickness for cementing material should be lessthan 50 µm and also should not be 10 µmabove any value declared by the manufacturer,so the company FGM - Dentscare does notdeclare the film thickness of the product inquestion (Allcem), so the result of acceptancemust be less than 50 µm | From the results obtained it isobserved that the film thicknessis ≤ 40 µm, thus complying withEN ISO 4049.Allcem Veneer APSSample 1: 17 μmSample 2: 15 μmSample 3: 13 μmSample 4: 09 μmSample 5: 05 μmAverage: 11.8 μmVariolinkSample 1: 25 μmSample 2: 18 μmSample 3: 27 μmSample 4: 20 μmSample 5: 20 μmAverage: 22.0 μm |
| Sorption: Maximum of 40 µm/mm³.Solubility: maximum of 7.5 µm/mm³. | The results demonstrate that theAllcem product complies thespecification in the EN ISO 4049Standard. | |
| Watersorption andsolubility. | Allcem Veneer APS:Sorption: 24.46 µg/mm³Solubility: 6.17 µg/mm³ | |
| Variolink:Sorption: 25.61 µg/mm³Solubility: 5.27 µg/mm³ | ||
| Radiopacity | The opacity value (equivalent to aluminum) of aspecimen with 1.0 mm thickness is given by$δα/δss$ .If this value is ≥ 1 mm, the material will be inaccordance with the first requirement where:If the manufacturer declares that the material isradiopaque, the radiopacity must be of athickness greater than or equal to the aluminummaterial and should not be 0.5 mm above anyvalue declared by the manufacturer. | The value found in thespecimens are between thesecond and third scale of thealuminum part, proving that thematerial is radiolucent accordingto the requirements of ISO 4049.Allcem Veneer APS: 2.47 mmVariolink: 2.36 mm |
| AcceleratedStabilityStudies | Study created to accelerate the possiblechemical degradation and/or physical changesof the ALLCEM VENEER APS product in forcedconditions of storage.The study was performed using independentmethods and references of the ASTM1980. | Considering the results observedat the end of the 129 days testperiod, the shelf-life of 2 years inthe storage condition of 25 °C forthe Allcem product can beconfirmed. |
| EvaluationReport ofLong-TermStability(Shelf) | Study designed to verify the physical andchemical characteristics of the productALLCEM VENEER APS during the expectedshelf life. The results are used to confirm theexpiration date and storage conditions.The study was performed using independentmethods and references of the ASTM1980. | Based on the results obtainedover the 24 months of the study,we can ensure that AllcemVeneer APS maintains itsproperties in the indicatedstorage condition for a period of2 years. |
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Image /page/9/Picture/1 description: The image shows the logo for DentsCare. The logo features a stylized letter D with three horizontal lines emanating from the left side of the D. Below the logo is the text "DentsCare" in a sans-serif font. The text to the right of the logo includes the address and phone number.
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K191389
Image /page/10/Picture/1 description: The image shows a logo for DentsCare. The logo features a stylized letter 'D' in a gray color. Three horizontal lines are present within the 'D', suggesting movement or airflow. Below the 'D', the text 'DentsCare' is written in a sans-serif font, also in a gray color.
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 Allcem Veneer APS and the predicate comparison, we conclude the specified intentions of use for this product was reached as well as the substantially equivalency with the predicate. The products have similar formulation, indication of use and are in comply with ISO 4049. Observing the results above, Allcem Veneer APS shows similar results when compared to the predicate device, Variolink and is substantially equivalent.
§ 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.