(522 days)
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- Fabrication of long-lasting temporary restorations;
- Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.
The provided text is a 510(k) summary for the device PrimmaArt, a temporary crown and bridge resin. It describes the device, its indications for use, comparison with a predicate device (Structur 3), and non-clinical testing results.
However, the document does not contain information regarding a study involving human readers, ground truth establishment, sample sizes for test or training sets, or expert qualifications for AI/ML device performance analysis. The acceptance criteria and "device performance" in the context of this document refer to physical and chemical properties of the dental resin, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/ML device per the input prompt's structure. The device described, PrimmaArt, is a material, not a software or AI/ML device.
However, I can extract the acceptance criteria and reported device performance for the dental resin based on the provided tables:
1. Table of Acceptance Criteria and Reported Device Performance (for PrimmaArt dental resin):
| Test | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Setting time and heat released | Setting time: No more than 5 minutes (EN ISO 4049). Project target: 2'30" - 3'10". Heat released: Less than 0.60 mW/mg. | Setting time: 2m48s. Heat released: 0.30 mW/mg. (Product evaluated using DSC and presented results according to design input). |
| Viscosity | Base and catalyzer viscosity: Between 60000 and 100000 mPa.s (according to design input). | Base Paste: 92733 mPa.s. Catalyst paste: 90133 mPa.s. (Results within defined limits). |
| Surface Finish | Polymerized composite presents a reflective surface (ISO 10477). | Surface of specimen was reflective (in accordance with ISO 10477). |
| Shade consistency and color stability | No more than a small color change (EN ISO 4049 and ISO 7491). | Only a small color difference (acceptable according to ISO 4049) was attested in one comparison; no changes identified in other analyses. |
| Radiopacity | Value > 1.0 mm when compared to aluminum scale (ISO 4049). | 1.68 mm. (FGM Bisacrylic resin presented results above that specified by ISO 4049). |
| Flexing Resistance | Flexural strength ≥ 50MPa (ISO 10477). | 65.5 MPa. (All results within values specified in ISO 10477). |
| Water sorption and solubility | Sorption: Maximum of 40 µg/mm³. Solubility: Maximum of 7.5 µg/mm³ (ISO 4049). | Sorption: 9.389 ± 1.26 µg/mm³. Solubility: 1.542 ± 0.32 µg/mm³. (All results below within the specified limit). |
| Working time | At least 60 seconds (EN ISO 4049 for cementation materials). | More than 60 seconds. |
| Accelerated Stability Studies | Product should not show significant changes in physical-chemical properties after accelerated degradation (study created to accelerate degradation). | Did not show significant changes in terms of its physical-chemical properties during the accelerated stability process (225 days). |
| Long-Term Stability (Shelf) | Verify physical and chemical characteristics during expected shelf life to confirm expiration date. | No conclusive data about shelf life yet; estimated 2 years shelf life based on accelerated stability test. |
| Microhardness Vickers | Hardness (HV) between 5 and 15 HV, and similar or superior to competitor (Project Entry Requirements). | 11.81 HV. (All results within the specified limit). |
2. Sample size used for the test set and the data provenance:
- This information is not applicable as the study involves material testing, not an AI/ML algorithm or dataset. The tests are performed on samples of the PrimmaArt resin. The data provenance is DentsCare LTDA, Brazil, as the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device. Ground truth, in this context, refers to the adherence of the material's properties to international standards (e.g., ISO) and internal design inputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device evaluated by human readers. The assessment is based on direct measurement against established material performance standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device. The performance tests are for the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing of the dental resin, the "ground truth" or reference for acceptance is defined by recognized international standards (e.g., ISO 7491, ISO 10477, ISO 4049) and the device's internal design input specifications.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. There is no concept of a "training set" for a dental resin material in this context.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 26, 2024
DentsCare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 2950 West Cypress Creek Rd. Ste 110 Fort Lauderdale, Florida 33309
Re: K231859
Trade/Device Name: PrimmaArt Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, POW Dated: September 27, 2024 Received: September 27, 2024
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
MICHAEL E. ADJODHA -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231859
Device Name PrimmaArt
Indications for Use (Describe)
- Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- Fabrication of long-lasting temporary restorations;
- Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
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/4/Picture/0 description: The image contains 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).
K231859
Section 5
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) 99160-4500
E) Preparation Date: November 25, 2024
F) Classification Name: Crown And Bridge, Temporary, Resin
Common / Usual Name: Temporary crown and bridge resin
Proprietary Name: PrimmaArt
Product Code: EBG
Class: Class II
Regulation: 21 CFR 872.3770
G) Device Description
Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.
H) Substantial Equivalence (Predicates):
| PredicateType | PredicateDescription | 510(k) Number | Model | Company |
|---|---|---|---|---|
| Predicate | Main Predicate | K120779 | Structur 3 | VOCOGmbH |
| Reference | BiocompatibilityReference | K191306 | Llis, Vittra APS | DentscareLTDA |
The PrimmaArt is equivalent with the following product:
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Image /page/5/Picture/0 description: The image contains the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines inside the upper part of the "D", resembling waves or airflow. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray, with the first letter capitalized.
DENTSCARE LTDA BENTOGARE ETDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA
CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Reference | BiocompatibilityReference | K201707 | Opallis, Opallis Flow | DentscareLTDA |
|---|---|---|---|---|
| Reference | BiocompatibilityReference | K183465 | Allcem, Allcem Core | DentscareLTDA |
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Image /page/6/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, and the name 'DentsCare' written below. The contact information includes the company name, address (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL), and phone number (Ph: 55 - 47 - 3441-6131).
I) Indications for Use Statement:
- · Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
- · Fabrication of long-lasting temporary restorations;
- · Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.
| Indications for Use Comparison | |
|---|---|
| PrimmaArt | Structur 3 |
| - Fabrication of temporary crowns, bridges, inlays, onlays and veneers; | - Fabrication of temporary crowns, bridges, inlays, onlays, partial crowns, veneers and temporary posts. |
| - Fabrication of long-lasting temporary restorations; | - Fabrication of long-term temporary restorations |
| - Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal. | - Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal. |
Discussion:
The products are similar. Both devices are indicated to produce temporary pieces (crowns, bridges, inlays, onlays and veneers), long-term temporary restorations and rebasing of prefabricated temporary crowns made or metal.
J) Technological Characteristics Comparison:
The predicate device used to establish equivalence for the PrimmaArt device is outlined below. This section of this submission will provide a comparison of dechnical specifications of the PrimmaArt to the predicate device stratified by functional modality.
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Image /page/7/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter 'D' with three horizontal lines inside it, along with the name 'DentsCare' written below. The contact information includes the address 'AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL' and the phone number 'Ph: 55 - 47 - 3441-6131'.
| DeviceManufacturerandCommon Name | PrimmaArtDentscare Ltda | Structur 3VOCO GmbH |
|---|---|---|
| 510k # | Not assigned yet | K120779 |
| Classification | Class II | Class II |
| Regulation # | 21 CFR 872.3770 | 21 CFR 872.3770 |
| Product Code | EBG | EBG |
| Classification Name | Temporary crown and bridge resin | Temporary crown and bridge resin |
| Patient Population | All the groups | All the groups |
| Prescription Use | RX only | RX only |
| Environment | Dental prosthetics and authorized laboratoriesand clinics.PrimmaArt must be stored in temperaturesbetween 5° to 25°C. | Dental prosthetics and authorized laboratoriesand clinics.Structur 3 must be stored in temperaturesbetween 4° to 23°C |
| Applicable Standards | ISO 7491; ISO 10477; ISO 10993; ISO 4049 | ISO 7491; ISO 10477; ISO 10993; ISO 4049 |
| Device Sterilization | Not Applicable | Not Applicable |
| Primary Package Container: | Syringe and cartridge | Syringe and cartridge |
| Shelf life | 2 years | Not disclosed by the manufacturer |
| Use the same materials orsubstances in contact withthe same human tissuesor body fluids? | YES | YES |
| Is the product in complianceto EN ISO 10993? | YES | YES |
| Tissues | Enamel and Dentin | Enamel and Dentin |
| Reusable | NO | NO |
| Duration | Temporary | Temporary |
| Part of body | Oral, teeth | Oral, teeth |
| itusedforthelssameclinical condition? | yes | yes |
| Is it used at the same site in the body? | yes | yes |
| Is it used in a similar population? | yes | yes |
| Is it used for the same intended purpose? | yes | yes |
| Is not foreseen to deliver significantly different performances? | no | no |
| Is it similar conditions of use? | yes | yes |
| Is it similar specifications and properties | yes | yes |
| Is it similar principles of operation? | yes | yes |
| CLINICAL STEP | PrimmaArt (Dentscare) | Structur 3 (VOCO) |
| Two options: total isolation orrelative isolation | YES | YES |
| Applicationaccordingtoadhesive technique | YES | YES |
| Requirefinishingandpolishing | YES | YES |
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Image /page/8/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter D with horizontal lines inside it, above the word "DentsCare" in a sans-serif font. The text "Dents" is also visible, but it is unclear what it refers to.
| Specification | PrimmaArt | Structur 3 |
|---|---|---|
| Shade consistency and colorstability ISO 4049 e 7491 | No more than a small color change | Not performed. Not disclosed by themanufacturer. |
| Setting time and heatreleasedISO 4049 | Setting time: 2m48sHeat released: 0.30 mW/mg | Setting time: 3m02sHeat released: 0.31 mW/mg |
| Viscosity | Base Paste: 92733 mPa.sCatalyst paste: 90133 mPa.s | Not disclosed by the manufacturer |
| Surface Finish ISO 10477 | According to ISO 10477, the polymerized | Not disclosed by the manufacturer |
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Image /page/9/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with three horizontal lines inside. The contact information includes the address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and the phone number: Ph: 55 - 47 - 3441-6131.
| composite has a shiny surface | ||
|---|---|---|
| Radio-opacity ISO 4049 | 1.68 mm | < 1 |
| Flexing Resistance ISO 10477 | 65.5 MPa | 68.0 MPa |
| Water sorption and solubilityISO 4049 | Sorption: 9.389 ± 1.26 µg/mm³Solubility: 1.542 ± 0.32 µg/mm³ | Sorption: 10.527 ± 1.29 µg/mm³Solubility: 2.016 ± 0.31 µg/mm³ |
| Working time | More than 60 seconds | Not disclosed by the manufacturer |
| Microhardness Vickers | 11,81 HV | 4,55 HV |
Discussion:
The subject device is similar to the predicate device in that they are light activated, usar self-curing, restorative composite, permanently cementing restorations of temporary pieces for indirect dental procedures. The subject device and the predicate device have substantially equivalent of indications for use, technological properties and fulfil the ISO 7491 e ISO 10477 ISO 4049 minimum requirements. Despite the minor differences in formulation between the predicate, they can be considered equivalent, since tifferences does not affect the products laboratorial and clinical performance and safety.
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Image /page/10/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" with three horizontal lines emanating from the top left corner, suggesting movement or airflow. Below the symbol, the word "DentsCare" is written in a clean, sans-serif font, with the "D" in a slightly larger size and a darker shade of gray compared to the rest of the word.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
K)Applicable Standards:
In order to reach substantially equivalent to the predicate device PrimmaArt was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry.
ISO 7491:2000 – Dental materials – Determination of colour stability
ISO 10477:2018 – Dentistry – Polymer-based crown and veneering materials
ISO 4049:2009 - 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)
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Image /page/11/Picture/0 description: The image shows a logo for a company called DentsCare. The logo features a stylized letter "D" with horizontal lines emanating from it, suggesting movement or flow. Next to the logo is the text "DentsCare" in a clear, sans-serif font.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
L) Non-clinical Testing:
In order to study the performance of the product, pre-clinical tests were performed according to the table below.
| Test | Specification | Results |
|---|---|---|
| Settingtimeandheatreleased | According to EN ISO 4049, forself curing restorativematerials, the setting timeshall be no more than 5minutes.The time considered for theproject is 2'30" and 3'10" andthe heat released less than0,60mW/mg. | Product was evaluated using theDifferential Scanning CalorimetryTest (DSC) and presented resultsaccording to the design input. |
| Viscosity | According to the design inputthe viscosity of the base andthe catalyzer should bebetween 60000 and 100000mPa.s. | The test was done using theBrooksfield digital viscosimeter andthe results were within the definedlimits. |
| Surface Finish | According to the ISO 10477standard, the specification forfinishing of a surface is thatthe polymerised compositepresents a reflective surface. | It was observed that the surface ofthe specimen was reflective, so thismaterial is considered to be inaccordance with the specificationsof the ISO 10477 standard. |
| Shadeconsistencyandcolorstability | According to EN ISO 4049 andISO 7491, acceptance must bemade as long as there is nomore than a small colorchange. | Only a small color difference(acceptable according to ISO 4049)was attested, when comparingSample 3 (color A3) with BisacrilicTechnical Profile FGM. In the otheranalyzes, no changes wereidentified. |
| Radiopacity | According to ISO 4049, thematerialisconsideredradiopaque if the specimen hasa value of > 1.0 mm, whencompared to the aluminumscale, therefore, the value of"X" obtained through theequation of the line, must be >1. | The FGM Bisacrylic resin, presentedresults above that specified by ISO4049. |
| FlexingResistance | According to ISO 10477, thespecifiedflexural strength is≥50MPa. | The FGM Bisacrylictyperesinpresented all the results within thevalues specified in the ISO10477 standard,therefore,thematerialmeetstherequirementsdeterminedin |
| terms of 3-point Flexural Strength. | ||
| Water sorptionand solubility | According to ISO 4049, thespecified for sorption is amaximum of 40 µg/mm³ andfor solubility a maximum of 7.5µg/mm³. | All results below are within thespecified limit, therefore thematerial is considered to conform. |
| Working time | According to EN ISO 4049, theworking time for cementationmaterials must be at least 60seconds. | The results show that the producthas a working time of more than60 seconds. |
| AcceleratedStabilityStudies | Study created to accelerate thepossible chemical degradationand/or physical changes of theproduct in forced conditions ofstorage. | The FGM Bisacrylic Resin productdid not show significant changes interms of its physical-chemicalproperties during the acceleratedstability process (225 days). |
| EvaluationofReportLong-TermStability(Shelf) | Study designed to verify thephysical and chemicalcharacteristics of the productduring the expected shelf life.The results are used to confirmthe expiration date and storageconditions. | We don't have any conclusive dataabout shelf life yet. At the momentwe are using the estimated shelflife in 2 years in the storagecondition of 25°C, based on noaccelerated stability test. |
| MichohardnessVickers | According to the Project EntryRequirements, the Hardness(HV) must be between 5 and15 HV, and in the same way,the results must be similar orsuperior (justified) whencompared to the competitorunder study. | All results are within the specifiedlimit, so the material is consideredas conform. |
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Image /page/12/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color, with three horizontal lines emanating from the left side of the "D", suggesting movement or flow. Below the symbol, the word "DentsCare" is written in a sans-serif font, also in the same muted blue-gray color, completing the branding for the dental care company.
Conclusion: Based on the performance test applied to this PrimmaArt and the predicate comparison (Structur 3), we conclude that the device in question is substantially equivalent with the predicate, as all products meet the same recognized standards.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.