(163 days)
Opus Bulk Fill APS
- Direct restorations in posterior teeth (permanent and deciduous) in increments of up to 5mm, including the occlusal surface;
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Reconstructive build-up;-
- Base and lining of direct restorations;
- Repair of small defects of the enamel;
- Repair of temporary acrylic and resin materials
Opus Bulk Fill Flow APS
- Base/lining underneath direct restorations.
- Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy
- Pit and fissure sealant
- Tunnel-type preparation.
- Repair of enamel defects
- Bonding of tooth fragments.
- Repair in composite resin
- Non-carious cervical lesions.
- Planning of preparation walls.
- Core build-up
Opus Bulk Fill APS is a light-curing composite recommended for restorations performed in large increments. The technical characteristics of the product allow the professional to use increments of up to 5mm in the cavities, including the occlusal surface (it does not require an additional capping layer). The composite has approximately 79% of load filler (in mass). 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.
Opus Bulk Fill Flow is a bulk-fill flowable light-curing composite (fluid) recommended to be used as base and lining of restorations on posterior teeth. That feature associated to its cure depth – due to the composite's translucency – allows Opus Bulk Fill Flow to be applied in increments of up to 4mm, reducing the time for restoring large cavities.
The Opus Bulk Fill APS and Opus Bulk Fill Flow APS devices are dental restorative materials. The acceptance criteria and supporting study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Specification) for Opus Bulk Fill APS | Reported Performance (Results) for Opus Bulk Fill APS | Acceptance Criteria (Specification) for Opus Bulk Fill Flow APS | Reported Performance (Results) for Opus Bulk Fill Flow APS |
|---|---|---|---|---|
| Sensitivity to environment lighting - ISO 4049 | Physical homogeneity of the sample (no difference when compared to material not exposed to ambient light) | All results are within the range specified by ISO 4049. | Physical homogeneity of the sample (no difference when compared to material not exposed to ambient light) | All results are within the range specified by ISO 4049. |
| Depth of Cure - ISO 4049 | > 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. | > 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. |
| Colour tone stability after radiation and water absorption - ISO 4049 and ISO 7491 | No more than a small change in color, visually inspected by three observers with normal vision, comparing at 200-300mm for no more than 2 seconds, in a light chamber at Day Light - D65 mode, on a diffuse white background (90% reflectance) surrounded by a grey background (30 ± 5% diffuse reflectance). | All comparisons were carried out by three observers with normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician. They did not attest to any color difference in the samples analyzed. The results demonstrate that the product meets ISO 4049. | No more than a small change in color, visually inspected by three observers with normal vision, comparing at 200-300mm for no more than 2 seconds, in a light chamber at Day Light - D65 mode, on a diffuse white background (90% reflectance) surrounded by a grey background (30 ± 5% diffuse reflectance). | All comparisons were carried out by three observers with normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician. They did not attest to any color difference in the samples analyzed. The results demonstrate that the product meets ISO 4049. |
| Radiopacity - ISO 4049 | Optical density/grey value for the specimen thickness (δs) should correspond to the second and third scale of the aluminum part. | The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according to the requirements of ISO 4049. | Optical density/grey value for the specimen thickness (δs) should correspond to the second and third scale of the aluminum part. | The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according to the requirements of ISO 4049. |
| Flexing Resistance - ISO 4049 | ≥ 80MPa | All results are greater than the specified threshold, therefore the material is considered as conformant. | ≥ 50MPa | All results are greater than the specified threshold, therefore the material is considered as conformant. |
| Water sorption and solubility - ISO 4049 | Sorption: Maximum of 40 µm/mm³; Solubility: maximum of 7.5 µm/mm³ | The results demonstrate that the product complies the specification in the EN ISO 4049 Standard. | Sorption: Maximum of 40 µm/mm³; Solubility: maximum of 7.5 µm/mm³ | The results demonstrate that the product complies the specification in the EN ISO 4049 Standard. |
| Accelerated Stability Studies | No significant chemical degradation and/or physical changes in forced storage conditions. | Considering the results observed at the end of the 274 days test period, the shelf-life of 3 years in the storage condition of 30 °C for the product can be confirmed. | No significant chemical degradation and/or physical changes in forced storage conditions. | Considering the results observed at the end of the 149 days test period, the shelf-life of 2 years in the storage condition of 27 °C for the product can be confirmed. |
| Evaluation Report Of Long-Term Stability (Shelf) | Verification of physical and chemical characteristics during expected shelf life to confirm expiration date and storage conditions. | Considering the results observed at the end of the 36 months of the long-term test (shelf), the shelf life of 3 years in the storage condition of 30°C for the product can be confirmed. | Verification of physical and chemical characteristics during expected shelf life to confirm expiration date and storage conditions. | We don't have any conclusive data about shelf life yet. At the moment we are using the estimated shelf life in 2 years in the storage condition of 27 ° C, based on no accelerated stability test. |
| Fluoride release | (Specification not explicitly stated, but implied to be within acceptable limits for dental materials as it's an evaluation of the rate) | The results of the fluoride release assay demonstrate no release of fluoride ions. | (Not applicable/not tested for Flow APS in the provided document) | (Not applicable/not tested for Flow APS in the provided document) |
| Intensity and wavelength for photocuring | The product should demonstrate the ability to polymerize with different wavelengths and power densities from photopolymerizers. | The test results demonstrate the ability of polymerization resin with differencing light devices. | (Not applicable/not tested for Flow APS in the provided document) | (Not applicable/not tested for Flow APS in the provided document) |
| Filler particle size distribution (microns) | Grain size analysis and optical characteristics within specifications. | The test results demonstrate the microns within the specifications. | Grain size analysis and optical characteristics within specifications. | The test results demonstrate the microns within the specifications. |
2. Sample size used for the test set and the data provenance:
The provided document does not explicitly state the numerical sample size for each specific test, nor does it detail the provenance (e.g., country of origin, retrospective/prospective) of the materials tested. The tests were "pre-clinical tests" performed in a laboratory setting to evaluate physical and chemical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
For the Colour tone stability after radiation and water absorption test, three observers were used. Their qualifications are stated as: "normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician."
For other physical and chemical tests, "ground truth" is established by the specifications defined in the ISO standards (ISO 4049, ISO 7491), rather than expert consensus on a specific test set in the same manner as, for example, image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
For the Colour tone stability test, the adjudication method was essentially a unanimous consensus of the three observers who "did not attest to any color difference in the samples analyzed." For other tests, the results are quantitative measurements compared against predefined ISO standard thresholds, not requiring expert adjudication in that context.
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:
This is not applicable. The devices (Opus Bulk Fill APS and Opus Bulk Fill Flow APS) are dental restorative materials, not AI-assisted diagnostic or assistive devices. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The devices are physical dental materials, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for evaluating the performance of these dental restorative materials is primarily based on international recognized standards (ISO 4049, ISO 10993-1, ISO 7491) which define objective physical and chemical properties and their acceptable ranges. For the color stability test, a form of expert consensus (three certified observers with normal vision) was used to visually confirm the absence of color change.
8. The sample size for the training set:
This is not applicable. These are physical materials, not machine learning algorithms. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for a physical dental material.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
September 4, 2019
DentsCare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K190758
Trade/Device Name: Opus Bulk Fill APS, Opus Bulk Fill Flow APS Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 3, 2019 Received: June 7, 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,
Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K190758
Device Name
Opus Bulk Fill APS and Opus Bulk Fill Flow APS
Indications for Use (Describe)
Opus Bulk Fill APS
-
Direct restorations in posterior teeth (permanent and deciduous) in increments of up to 5mm, including the occlusal surface;
-
Class V restorations (cervical caries, root erosion, wedge-shaped defects)
-
Reconstructive build-up;-
-
Base and lining of direct restorations;
-
Repair of small defects of the enamel;
-
Repair of temporary acrylic and resin materials
Opus Bulk Fill Flow APS
- Base/lining underneath direct restorations.
- Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy
- Pit and fissure sealant
- Tunnel-type preparation.
- Repair of enamel defects
- Bonding of tooth fragments.
- Repair in composite resin
- Non-carious cervical lesions.
- Planning of preparation walls.
- Core build-up
Type of Use (Select one or both, as applicable)
| X 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/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter D with horizontal lines inside. The 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).
Section 5 510(k) SUMMARY
June 13, 2019
A) Submitter's Name: DENTSCARE LTDA
Owner / Operator Registration Number: 3007210751
Manufacture Registration Number: 3007210751
- B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL
C) Phone and Fax Numbers
Phone: +55 (47) 34416131
D) Contact Person:
Roberta Uyara Tel.: +55 (47) 34416131
E) Preparation Date: June 13, 2019
F) Classification Name: Tooth Shade Resin Material
Common / Usual Name: Tooth shade resin material. Proprietary Name: Opus Bulk Fill APS and Opus Bulk Fill Flow APS Product Code: EBF Class: Class II Regulation: 21 CFR 872.3690
G) Device Description
Opus Bulk Fill APS
Opus Bulk Fill APS is a light-curing composite recommended for restorations performed in large increments. The technical characteristics of the product allow the professional to use increments of up to 5mm in the cavities, including the occlusal
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Image /page/4/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines inside the "D" to represent teeth. Below the symbol is the word "DentsCare" in a sans-serif font, also in gray.
SCARF I TDA EDGAR NELSON MEISTER, 474, JOINVILLE, TARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
surface (it does not require an additional capping layer). The composite has approximately 79% of load filler (in mass).
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.
Opus Bulk Fill Flow APS
Opus Bulk Fill Flow is a bulk-fill flowable light-curing composite (fluid) recommended to be used as base and lining of restorations on posterior teeth. That feature associated to its cure depth – due to the composite's translucency – allows Opus Bulk Fill Flow to be applied in increments of up to 4mm, reducing the time for restoring large cavities.
H) Substantial Equivalence:
The Opus Bulk Fill APS and Opus Bulk Fill Flow APS is equivalent with the following products:
| Equivalence | 510(k) Number | Model | Company |
|---|---|---|---|
| Predicate | K111958 | TETRIC EVOCERAMBULK FILL | IVOCLARVIVADENT AG |
| Reference | K150393 | TETRIC EVOFLOWBULK FILL | IVOCLARVIVADENT AG |
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Image /page/5/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter D with three horizontal lines inside it, followed by the text "DentsCare" in a sans-serif font. To the right of the logo are the letters "DENTS" and "AV." followed by "Ph:", but the rest of the text is cut off.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
I) Indications for Use:
| Indications for Use Comparison | ||
|---|---|---|
| Opus Bulk Fill APS and Opus Bulk FillFlow APS | TETRIC EVOFLOW BULK FILLTETRIC EVOCERAM BULK FILL | Discussion |
| Opus Bulk Fill APS– Direct restorations in posterior teeth(permanent and deciduous) in increments ofup to 5mm, including the occlusal surface;– Class V restorations (cervical caries, rooterosion, wedge-shaped defects)– Reconstructive build-up;–– Base and lining of direct restorations;– Repair of small defects of the enamel;– Repair of temporary acrylic and resinmaterialsOpus Bulk Fill Flow APS– Base/lining underneath direct restorations.– Small, non occlusal stress-bearing class Irestorations according to minimally invasivefilling therapy– Pit and fissure sealant– Tunnel-type preparation.– Repair of enamel defects– Bonding of tooth fragments.– Repair in composite resin– Non-carious cervical lesions.– Planning of preparation walls.– Core build-up | Tetric Evoceram Bulk Fill (Predicate)– Restoration of Deciduous teeth– Restorations in the posterior region(Classes I and II)– Class V restorations (cervical caries, rooterosion, wedge-shaped defects)– Extended fissure sealing in molars andpremolarsTetric Evoflow Bulk Fill (Reference)– As initial layer / first increment in Class Iand II composite restorations inpermanent teeth– Restorations in deciduous teeth | Opus Bulk Fill APS x Tetric Evoceram Bulk FillReconstructive build-up, base and lining of directrestorations, repair of small defects of the enamel andrepair of temporary acrylic and resin materials areexamples of direct restauration. As a conclusion, thesubject and the predicate have the same indication ofuse.Opus Bulk Fill Flow APS x Tetric Evoflow Bulk Fill– Base/lining: are the restorations made under otherrestorative material, such as initial layer. This mainindication has as examples: Tunnel-type preparation,Planning of preparation walls and Core build-up.– Small, non occlusal stress-bearing class I restorationsaccording to minimally invasive filling therapy:restorations made in regions that do not receive directmasticatory load, according to a minimally invasivetherapy.The following indications are related to this definition:Pit and fissure sealant, Repair of enamel defects,Bonding of tooth fragments, Repair in composite resinand Non-carious cervical lesions.Since the product Tetric Evoflow Bulk Fill is indicated forrestorations in deciduous teeth, not limiting your use asinitial layer, it's imply the material can be applied inocclusal surface in this situation. Taking into accountthat the deciduous dentition receives a lowermasticatory load, the situation of these indicationsmentioned above in permanent teeth fits in the samesituation.Restorations are clinical known for indication topermanent and deciduous teeth |
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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 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).
J) Technological Characteristics Comparison:
The predicate and reference devices used to establish substantial equivalence for the Opus Bulk Fill Flow APS device is outlined below. This section of this submission of design, materials, and technical specifications of the Opus Bulk Fill APS and Opus Bulk Fill Flow APS to each of the predicate devices stratified by functional modality.
| Device Manufacturerand Common Name | Opus Bulk Fill APS andOpus Bulk Fill FlowAPSDentscare | TETRIC EVOCERAM BULK FILLIVOCLAR VIVADENT AG(Predicate) | TETRIC EVOFLOW BULK FILLIVOCLAR VIVADENT AG(Reference) |
|---|---|---|---|
| 510k # | Not assigned yet | K111958 | K150393 |
| Classification | Class II | Class II | Class II |
| Regulation # | 21 CFR 872.3690 | 21 CFR 872.3690 | 21 CFR 872.3690 |
| Product Code | EBF | EBF | EBF |
| Classification Name | Tooth Shade ResinMaterial | Tooth Shade Resin Material | Tooth Shade Resin Material |
| Patient Population | All the groups | All the groups | All the groups |
| Prescription Use | RX only | RX only | RX only |
| Environment | Dental prosthetics andauthorized laboratoriesand clinics.Opus Bulk Fill APS andOpus Bulk Fill Flow APSmust be stored intemperatures between 5°to 27°C. | Dental prosthetics and authorizedlaboratories and clinics.TETRIC must be stored intemperatures between 2° to 28°C | Dental prosthetics and authorizedlaboratories and clinics.TETRIC must be stored intemperatures between 2° to 28°C |
| ApplicableStandards | ISO 4049 ; ISO 10993-1 | ISO 4049; ISO 10993-1 | ISO 4049; ISO 10993-1 |
| Device Sterilization | Not Applicable | Not Applicable | Not Applicable |
| Primary PackageContainer : | Syringe and Capsule | Syringe and Capsule | Syringe and Capsule |
| Shelf life | 2 years | Not declared | Not declared |
| Use the samematerials orsubstances incontact with thesame human tissuesor body fluids? | YES | YES | YES |
| Is the product incompliance toEN ISO 10993 ? | YES | YES | YES |
| Tissues | Enamel and Dentin | Enamel and Dentin | Enamel and Dentin |
| Reusable | NO | NO | NO |
| Duration | Permanent | Permanent | Permanent |
| Part of body | Oral, teeth | Oral, teeth | Oral, teeth |
| Is it used for thesame clinicalcondition? | yes | yes | yes |
| Is it used at thesame site in thebody? | yes | yes | yes |
| Is it used in asimilar population? | yes | yes | yes |
| Is it used for thesame intendedpurpose? | yes | yes | yes |
| Is not foreseen todeliver significantlydifferentperformances? | no | no | no |
| Is it similarconditions of use? | yes | yes | yes |
| Is it similarspecifications andproperties | yes | yes | yes |
| Is it similarprinciples ofoperation? | |||
| yes | yes | yes |
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Image /page/7/Picture/0 description: The image contains the logo for DentsCare. The logo features a stylized letter D with three horizontal lines emanating from the top right corner, suggesting movement or flow. Below the symbol, the word "DentsCare" is written in a clean, sans-serif font, with the "D" in "DentsCare" matching the color and style of the symbol above.
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Image /page/8/Picture/0 description: The image contains the logo for DentsCare. The logo features a stylized letter D with three horizontal lines emanating from the left side, followed by the text "DentsCare" in a sans-serif font. To the right of the logo, there is text that reads "DEN", "AV.", and "Ph:", suggesting contact information or an address.
| Opus Bulk Fill APS | Opus Bulk Fill Flow APS | Tetric Evoceram Bulk Fill | |
|---|---|---|---|
| Layer thickness/Curing Depth | 4.61 mm | 4.39 mm | 3.65 mm |
| Sensitivity to ambient light | Homogeneous | Homogeneous | Homogeneous |
| Flexural Strength | 129.80 MPa | 84.47 MPa | 101.2 MPa |
| Water Sorption | 26.85 µg/mm³ | 29.06 µg/mm³ | 29.00 µg/mm³ |
| Solubility | 5.61 µg/mm³ | 5.46 µg/mm³ | 5.21 µg/mm³ |
| Radiopacity | 2.09 mm | 2.36 mm | 1.58 mm |
| Color stability | Stable | Stable | Stable |
Discussion:
The subject device is similar to the predicate devices in that they are all dual-curing, radio-opaque and self-adhesive resin cements to be used for permanently cementing restorations.
The subject device and the predicate devices have substantially equivalent of indications for use, shelf life, physical and mechanical properties. Despite differences in properties, these do not impact the safety and performance of the product, since all products meet the International Standard ISO 4049 requirements and it does not affect the substantial equivalence.
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Image /page/9/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter 'D' in a muted blue-gray color. Three horizontal lines are present within the 'D', suggesting movement or airflow. Below the symbol, the word 'DentsCare' is written in a bold, sans-serif font, also in the same muted blue-gray color.
R NELSON MEISTER, 474, JOINVILLE, RINA 89219-501 BRAZIL - 3441-6131
K) Applicable Standards:
In order to reach substantially equivalent to the predicate device Opus Bulk Fill APS and Opus Bulk Fill Flow APS was developed, as well produced in compliance with recognized international requlations and standards for the medical device industry.
ISO 4049 - Dentistry - Polymer-based restorative materials
ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ENISO 10993-1:2009)
Conclusion:
Based on compliance with the international standard and requlation mentioned above, the device Opus Bulk Fill APS and Opus Bulk Fill Flow APS demonstrate equivalency to the predicates above.
L) Risk Management
In order to identified and mitigate the risks to health associated with the use of dental composite resin we have developed the risk analysis management file which includes the risk analysis method and results.
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Image /page/10/Picture/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter D with 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).
M) Non-clinical Testing:
In order to study the performance of the product, pre-clinical tests were performed according to the table below, for details about test results please see attachments below.
OPUS BULK FILL APS
In order to study the performance of the product, pre-clinical tests were performed according to EN ISO 4049, table below with the results found.
| 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. | All results are within the range specified by ISO 4049. |
| 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. |
| Colour tone stability after radiation and water absorption - ISO 4049 and ISO 7491 | The acceptance must be performed provided that there is no more than a small change in colour, it must be proven as follows:a)comparisons should be made by visual inspection and analysed by three observers with normal vision, who do not identify any differences in 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%. | All comparisons were carried out by three observers with normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician. They did not attest to any color difference in the samples analyzed.The results demonstrate that the product meets ISO 4049. |
| Radiopacity - ISO 4049 | Compare the individual optical drives of each aluminium scale against the density of each scale (this check must be performed using ISO 4049 as reference). Get the value of the optical density/grey | The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according to the requirements of ISO 4049 |
| value for the δs thickness of the specimenand determine the corresponding value ofaluminium, δа. | ||
| FlexingResistance - ISO4049 | According to the EN ISO 4049 standard thespecification for flexural strength is≥80MPa. | All results are greater than the specifiedthreshold, therefore the material isconsidered as conformant. |
| Water sorptionand solubility.- ISO 4049 | Sorption: Maximum of 40 µm/mm3.Solubility: maximum of 7.5 µm/mm3. | The results demonstrate that the productcomplies the specification in the EN ISO4049 Standard. |
| AcceleratedStability Studies | Study created to accelerate the possiblechemical degradation and/or physicalchanges of the product in forced conditionsof storage. | Considering the results observed at theend of the 274 days test period, the shelf-life of 3 years in the storage condition of30 °C for the product can be confirmed. |
| EvaluationReport Of Long-Term Stability(Shelf) | Study designed to verify the physical andchemical characteristics of the productduring the expected shelf life. The resultsare used to confirm the expiration dateand storage conditions. | Considering the results observed at theend of the 36 months of the long-term test(shelf), the shelf life of 3 years in thestorage condition of 30°C for the productcan be confirmed. |
| Fluoride release | Evaluation of fluoride release rate insolution after 7 days in the oven at 37o C | The results of the fluoride release assaydemonstrate no release of fluoride ions. |
| Intensity andwavelength forphotocuring | Study designed to evaluate the curingdepth using photopolymerizes withdifferent wavelengths and power density | The test results demonstrate the abilitypolymerization resin with differencing lightdevices. |
| Filler particlesize distribution(microns) | Study designed to verify the grainsizeanalysis and optical characteristics. | The test results demonstrate the micronswithin the specifications. |
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Image /page/11/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color. Three horizontal wavy lines are embedded within the upper part 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.
OPUS BULK FILL FLOW APS
In order to study the performance of the product, pre-clinical tests were performed according to EN ISO 4049, table below with the results found.
| Test | Specification | Results |
|---|---|---|
| Sensitivitytoenvironmentlighting - ISO4049 | According to the ISO 4049 standard,acceptance is related to the physicalhomogeneity of the sample, so thematerial was compared after the test tothe same material pressed betweencoverslips, but without exposure toambient light. Thus, there is no differencebetween the samples. | All results are within the range specifiedby ISO 4049. |
| Depth of Cure -ISO 4049 | According to ISO 4049, the specificationfor this material is that its curing depth is:> 1.0 mm for opaque materials and > 1.5mm for non-opaque materials. | All results are greater than the specifiedthreshold, therefore the material isconsidered to be in conformity. |
| Colour tonestability afterradiation andwaterabsorption - ISO4049 and ISO7491 | The acceptance must be performedprovided that there is no more than a smallchange in colour, it must be proven asfollows: | All comparisons were carried out bythree observers with normal eyesight(Tiago Vicente, Josley Habinzeureuterand Simone Brasil Carvalho), certifiedby a competent physician. They did notattest to any color difference in thesamples analyzed. |
| a)comparisons should be made by visualinspection and analysed by threeobservers with normal vision, who do notidentify any differences in colour, thiscomparison must be carried at a distanceof 200 to 300 mm for a period of no morethan 2 seconds; | ||
| b)perform the comparison cited in a) in alight chamber at Day Light - D65 mode; | The results demonstrate that theproduct meets ISO 4049. | |
| c)perform the comparison in paragraph a),by placing the specimen on a diffuse whitebackground of 90% approximatereflectance, and it should have as alimiting size the size of the specimen,which must be surrounded by a greybackground with a diffuse reflectance of 30± 5%. | ||
| RadiopacityISO 4049 | Compare the individual optical drives ofeach aluminium scale against the densityof each scale (this check must beperformed using ISO 4049 as reference).Get the value of the optical density/greyvalue for the δs thickness of the specimenand determine the corresponding value ofaluminium, δа. | The values found in the specimens arebetween the second and third scale ofthe aluminum part, proving that thematerial is radiolucent according to therequirements of ISO 4049 |
| FlexingResistance - ISO4049 | According to the EN ISO 4049 standard thespecification for flexural strength is≥50MPa. | All results are greater than the specifiedthreshold, therefore the material isconsidered as conformant. |
| Water sorptionand solubility.- ISO 4049 | Sorption: Maximum of 40 µm/mm3.Solubility: maximum of 7.5 µm/mm3. | The results demonstrate that theproduct complies the specification inthe EN ISO 4049 Standard. |
| AcceleratedStability Studies | Study created to accelerate the possiblechemical degradation and/or physicalchanges of the product in forced conditionsof storage. | Considering the results observed at theend of the 149 days test period, theshelf-life of 2 years in the storagecondition of 27 °C for the product canbe confirmed. |
| EvaluationReport Of Long- | Study designed to verify the physical andchemical characteristics of the productduring the expected shelf life. The results | We don't have any conclusive dataabout shelf life yet. At the moment weare using the estimated shelf life in 2 |
| Term Stability(Shelf) | are used to confirm the expiration dateand storage conditions. | years in the storage condition of 27 ° C,based on no accelerated stability test. |
| Filler particlesizedistribution(microns) | Study designed to verify the grainsizeanalysis and optical characteristics. | The test results demonstrate themicrons within the specifications. |
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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 gray color. Inside the "D", there are three horizontal lines, also in gray, that appear to represent movement or flow. Below the symbol is the text "DentsCare" in a sans-serif font, with the "D" in a larger size and bolder weight compared to the rest of the word.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare ph: 55 - 47 - 3441-6131
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Image /page/13/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines inside the "D" to represent teeth. Below the "D" is the word "DentsCare" in a sans-serif font, also in gray.
Conclusion: Based on the performance test applied to this Opus Bulk Fill APS and Opus Bulk Fill Flow APS and the predicate comparison, we conclude that the subject device is substantially equivalent to the predicate.
§ 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.