(277 days)
Not Found
No
The document describes a light-curing resin cement and a try-in accessory. The technology mentioned is "Advanced Polymerization System (APS)", which is a chemical system for light curing, not AI/ML. There is no mention of AI, ML, image processing, or data sets for training/testing.
No
This device is a resin cement used for bonding dental restorations, a function that is corrective or restorative, not therapeutic in the sense of treating a disease or condition.
No
This device is a resin cement used for the adhesive luting of ceramic and composite restorations. It is a treatment device rather than a diagnostic one, as its function is to bond dental materials. The "Try-in" accessory simulates chromatic effect but does not diagnose a medical condition.
No
The device description clearly indicates it is a light-curing resin cement and a try-in accessory, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the adhesive luting of dental restorations (veneers). This is a direct application within the oral cavity for structural and aesthetic purposes.
- Device Description: The device is a light-curing resin cement and a try-in paste. These are materials used for bonding and simulating the final appearance of dental restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Anatomical Site: The anatomical site is the oral cavity (tooth), where the device is directly applied. IVDs typically analyze samples taken from the body.
The device is a dental material used for restorative procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, tooth
Indicated Patient Age Range
Adults
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:
Test: Sensitivity to environment lighting – ISO 4049
Specification: 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.
Results: Present a Sensitivity to environment lighting superior to the acceptance criteria (> 60 sec).
Test: Depth of Cure - ISO 4049
Specification: 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.
Results: All results are greater than the specified threshold, therefore the material is considered to be in conformity.
Test: Color tone stability after radiation and water absorption - ISO 4049
Specification: The acceptance must be performed provided that there is no more than a small change in colour, it must be proven as follows: a) comparisons should be made by visual inspection and analyzed by three observers with normal vision, who do not identify any differences in colour, 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%.
Results: All comparisons were carried out by three observers with normal eyesight and certified by a competent physician. Any color difference in the samples analyzed were attested. The results demonstrate that the product meets ISO 4049.
Test: Flexural strength
Specification: According to the EN ISO 4049 standard the specification for flexural strength is ≥50MPa.
Results: All results are greater than the specified threshold, therefore the material is considered to be in conformity. Allcem Veneer APS: 110.90 MPa. Variolink: 91.84 MPa.
Test: Film Thickness.
Specification: According to the EN ISO 4049 standard the film thickness for cementing material should be less than 50 µm and also should not be 10 µm above any value declared by the manufacturer, so the company FGM - Dentscare does not declare the film thickness of the product in question (Allcem), so the result of acceptance must be less than 50 µm.
Results: From the results obtained it is observed that the film thickness is ≤ 40 µm, thus complying with EN ISO 4049. Allcem Veneer APS: Sample 1: 17 μm, Sample 2: 15 μm, Sample 3: 13 μm, Sample 4: 09 μm, Sample 5: 05 μm, Average: 11.8 μm. Variolink: Sample 1: 25 μm, Sample 2: 18 μm, Sample 3: 27 μm, Sample 4: 20 μm, Sample 5: 20 μm, Average: 22.0 μm.
Test: Water sorption and solubility.
Specification: Sorption: Maximum of 40 µm/mm³. Solubility: maximum of 7.5 µm/mm³.
Results: The results demonstrate that the Allcem product complies the specification in the EN ISO 4049 Standard. Allcem Veneer APS: Sorption: 24.46 µg/mm³, Solubility: 6.17 µg/mm³. Variolink: Sorption: 25.61 µg/mm³, Solubility: 5.27 µg/mm³.
Test: Radiopacity
Specification: The opacity value (equivalent to aluminum) of a specimen with 1.0 mm thickness is given by δα/δss. If this value is ≥ 1 mm, the material will be in accordance with the first requirement where: If the manufacturer declares that the material is radiopaque, the radiopacity must be of a thickness greater than or equal to the aluminum material and should not be 0.5 mm above any value declared by the manufacturer.
Results: The value 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. Allcem Veneer APS: 2.47 mm. Variolink: 2.36 mm.
Test: Accelerated Stability Studies
Specification: Study created to accelerate the possible chemical degradation and/or physical changes of the ALLCEM VENEER APS product in forced conditions of storage. The study was performed using independent methods and references of the ASTM1980.
Results: Considering the results observed at the end of the 129 days test period, the shelf-life of 2 years in the storage condition of 25 °C for the Allcem product can be confirmed.
Test: Evaluation Report of Long-Term Stability (Shelf)
Specification: Study designed to verify the physical and chemical characteristics of the product ALLCEM VENEER APS during the expected shelf life. The results are used to confirm the expiration date and storage conditions. The study was performed using independent methods and references of the ASTM1980.
Results: Based on the results obtained over the 24 months of the study, we can ensure that Allcem Veneer APS maintains its properties in the indicated storage condition for a period of 2 years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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. 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
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 "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
2
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) |
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/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 |
4
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 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. | Variolink Esthetic LC: |
| – Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic | |
| and composite restorations (inlays, onlays and veneers) | |
| – Only use Variolink Esthetic LC for restorations with a low thickness of 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.
8
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 |
|---|---|---|
| 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. | Present a Sensitivity to environment lighting superior to the acceptance criteria (> 60 sec). |
| 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. |
| Specimen | ||
| (mm) | ||
| CP 1 | ||
| CP 2 | ||
| CP 3 | ||
| Average: | ||
| Color 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 | ||
| colour, it must be proven as follows: | ||
| a) comparisons should be made by visual | ||
| inspection and analyzed by three observers with | ||
| normal vision, who do not identify any | ||
| differences in colour, 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 ofthe 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 and certified by a | ||
| competent physician. Any color | ||
| difference in the samples | ||
| analyzed were attested. | ||
| The results demonstrate that the | ||
| product meets ISO 4049. | ||
| Flexural | ||
| strength | According to the EN ISO 4049 standard the | |
| specification for flexural strength is ≥50MPa. | All results are greater than the | |
| specified threshold, therefore the | ||
| material is considered to be in | ||
| conformity | ||
| Allcem Veneer APS: 110.90 MPa | ||
| Variolink: 91.84 MPa | ||
| Film | ||
| Thickness. | According to the EN ISO 4049 standard the film | |
| thickness for cementing material should be less | ||
| than 50 µm and also should not be 10 µm | ||
| above any value declared by the manufacturer, | ||
| so the company FGM - Dentscare does not | ||
| declare the film thickness of the product in | ||
| question (Allcem), so the result of acceptance | ||
| must be less than 50 µm | From the results obtained it is | |
| observed that the film thickness | ||
| is ≤ 40 µm, thus complying with | ||
| EN ISO 4049. |
Allcem Veneer APS
Sample 1: 17 μm
Sample 2: 15 μm
Sample 3: 13 μm
Sample 4: 09 μm
Sample 5: 05 μm
Average: 11.8 μm
Variolink
Sample 1: 25 μm
Sample 2: 18 μm
Sample 3: 27 μm
Sample 4: 20 μm
Sample 5: 20 μm
Average: 22.0 μm |
| | Sorption: Maximum of 40 µm/mm³.
Solubility: maximum of 7.5 µm/mm³. | The results demonstrate that the
Allcem product complies the
specification in the EN ISO 4049
Standard. |
| Water
sorption and
solubility. | | Allcem Veneer APS:
Sorption: 24.46 µg/mm³
Solubility: 6.17 µg/mm³ |
| | | Variolink:
Sorption: 25.61 µg/mm³
Solubility: 5.27 µg/mm³ |
| Radiopacity | The opacity value (equivalent to aluminum) of a
specimen with 1.0 mm thickness is given by
$δα/δss$ .
If this value is ≥ 1 mm, the material will be in
accordance with the first requirement where:
If the manufacturer declares that the material is
radiopaque, the radiopacity must be of a
thickness greater than or equal to the aluminum
material and should not be 0.5 mm above any
value declared by the manufacturer. | The value 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.
Allcem Veneer APS: 2.47 mm
Variolink: 2.36 mm |
| Accelerated
Stability
Studies | Study created to accelerate the possible
chemical degradation and/or physical changes
of the ALLCEM VENEER APS product in forced
conditions of storage.
The study was performed using independent
methods and references of the ASTM1980. | Considering the results observed
at the end of the 129 days test
period, the shelf-life of 2 years in
the storage condition of 25 °C for
the Allcem product can be
confirmed. |
| Evaluation
Report of
Long-Term
Stability
(Shelf) | Study designed to verify the physical and
chemical characteristics of the product
ALLCEM VENEER APS during the expected
shelf life. The results are used to confirm the
expiration date and storage conditions.
The study was performed using independent
methods and references of the ASTM1980. | Based on the results obtained
over the 24 months of the study,
we can ensure that Allcem
Veneer APS maintains its
properties in the indicated
storage condition for a period of
2 years. |
9
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.
10
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.