Who is the manufacturer of Allcem Veneer APS?

Dentscare Ltda filed the 510(k) submission for Allcem Veneer APS (K191389).

What is the FDA product code for Allcem Veneer APS?

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Allcem Veneer APS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Allcem Veneer APS?

Variolink® Esthetic (K142389).

Who can help prepare an FDA 510(k) submission like Allcem Veneer APS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Allcem Veneer APS

K191389 · Dentscare Ltda · EBF · Feb 25, 2020 · Dental

Device Facts

Record ID	K191389
Device Name	Allcem Veneer APS
Applicant	Dentscare Ltda
Product Code	EBF · Dental
Decision Date	Feb 25, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Allcem Veneer APS is a light-curing resin cement used by dental professionals for the adhesive cementation of ceramic and composite veneers. The device utilizes an Advanced Polymerization System (APS), a combination of photo-initiators that amplify curing when exposed to light-curing units (400-500nm). It is supplied in single-component syringes in various shades. A Try-in accessory is provided to simulate the final chromatic effect before permanent cementation. The cement is applied following standard acid etching and adhesive techniques. By providing a low film thickness and high translucency, it facilitates the aesthetic bonding of thin restorations. The device is intended for use in dental clinics and laboratories to improve the retention and aesthetic outcome of indirect restorations.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4049 standards, including film thickness (11.8 µm), flexural strength (110.90 MPa), depth of cure (2.19 mm), radiopacity (2.47 mm), water sorption (24.46 µg/mm³), and solubility (6.17 µg/mm³). Accelerated stability and 24-month shelf-life studies were conducted per ASTM 1980. Results demonstrate compliance with ISO 4049 and equivalence to the predicate device.

Technological Characteristics

Light-curing resin cement composed of methacrylate monomers, camphorquinone, co-initiators, pigments, barium-aluminum-silicate salinized glass particles, and silicon dioxide. Form factor: single-component syringe. Energy source: external light-curing unit (≥ 450mW/cm², 400-500nm). Complies with ISO 4049 and ISO 10993-1.

Indications for Use

Indicated for adhesive luting of ceramic and composite restorations (up to 1.5mm thickness) in adults. Contraindicated for restorations with opaque infrastructure.

Regulatory Classification

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.

Predicate Devices

Variolink® Esthetic (K142389)

Related Devices

K210504 — PANAVIA Veneer LC · Kuraray Noritake Dental, Inc. · Jun 11, 2021
K241204 — TopCEM-Veneer Light Cure Veneer Cement · Rizhao Huge Biomaterials Company, Ltd. · Jun 28, 2024
K111836 — PERMASHADE VENEER CEMENT · Ultradent Products, Inc. · Sep 16, 2011
K073101 — AURAVENEER CEMENT · Denali Corporation · Jan 17, 2008
K180649 — BeautiCem Veneer Kit · Shofu Dental Corporation · Jun 11, 2018

Submission Summary (Full Text)

{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) | <input checked="true" type="checkbox"/> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> | ### 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}------------------------------------------------ K191389 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 <2mm that 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 and compositemrestorations (inlays, onlays, partial crowns, bridges). – Restorations made of opaque ceramics, e.g. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured. Variolink Esthetic Try-In: To evaluate the overall effect of the restoration in conjunction with the various Variolink 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. {5}------------------------------------------------ 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 | | Environment Storage Environment | Dental prosthetics and authorized laboratories and clinics. 5° to 25°C | Dental prosthetics and authorized laboratories and clinics. 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-silicate salinized glass particles and silicon dioxide. | The monomer of Variolink Esthetic is composed of urethane dimethacrylate and further methacrylate monomers. The inorganic fillers are ytterbium trifluoride 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 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 | | 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 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 | | Film Thickness | 11.8 µm | 22.0 µm | | Stability of tone and colour - ISO 4049 | The observers do not attest any difference of colour | The observers do not attest any difference of colour | | 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 to the acceptance criteria. | Present a Sensitivity to environment lighting superior to the acceptance criteria. | | Water sorption and solubility - ISO 4049 | Sorption: 24.46 µg/mm3 Solubility: 6.17 µg/mm³ | Sorption: 25.61 µg/mm3 Solubility: 5.27 µg/mm³ | {6}------------------------------------------------ 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 OR RELATIVE ISOLATION | YES | YES | | APPLICATION ACCORDING TO ADHESIVE TECHNIQUE | YES | YES | | SIZE FOR INCREMENTS | Up to 1.5mm | Up to 2mm | | LIGHTCURING UNIT | POWER ≥ 450mW/cm² and WAVELENGTH OF 400-500nm | POWER ≥ 500mW/cm2 and WAVELENGTH OF 400-500nm | | REQUIRE FINISHING AND POLISHING | YES | YES | {7}------------------------------------------------ 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. {8}------------------------------------------------ K191389 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.