(163 days)
No
The device description and performance studies focus on the material properties and curing characteristics of dental composites, with no mention of AI or ML.
No.
The device is a restorative dental material used for filling cavities and other dental repairs, not a device used for treating disease or health conditions.
No
The device description and intended use indicate that Opus Bulk Fill APS and Opus Bulk Fill Flow are light-curing composites used for direct restorations, fillings, bases, linings, and repairs of teeth, which are therapeutic and restorative functions, not diagnostic.
No
The device description clearly indicates it is a light-curing composite material, which is a physical substance used for dental restorations, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for direct dental restorations, fillings, and repairs within the oral cavity. These are clinical procedures performed directly on the patient's teeth.
- Device Description: The device is a light-curing composite material used for filling cavities and building up tooth structure.
- Anatomical Site: The anatomical site is the oral cavity, specifically teeth.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to diagnose diseases or conditions.
The Opus Bulk Fill APS and Opus Bulk Fill Flow APS are dental restorative materials used in vivo (within the living body) for treatment, not for diagnostic testing of samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, teeth
Indicated Patient Age Range
Patient Population: All the groups
Opus Bulk Fill APS: Direct restorations in posterior teeth (permanent and deciduous)
Intended User / Care Setting
Dental prosthetics and authorized laboratories and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing according to EN ISO 4049.
OPUS BULK FILL APS Tests:
- Sensitivity to environment lighting - ISO 4049: All results are within the range specified by ISO 4049.
- Depth of Cure - ISO 4049: 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: 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: 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: All results are greater than the specified threshold, therefore the material is considered as conformant.
- Water sorption and solubility. - ISO 4049: The results demonstrate that the product complies the specification in the EN ISO 4049 Standard.
- Accelerated Stability Studies: 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.
- Evaluation Report Of Long-Term Stability (Shelf): 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.
- Fluoride release: The results of the fluoride release assay demonstrate no release of fluoride ions.
- Intensity and wavelength for photocuring: The test results demonstrate the ability polymerization resin with differencing light devices.
- Filler particle size distribution (microns): The test results demonstrate the microns within the specifications.
OPUS BULK FILL FLOW APS Tests:
- Sensitivity to environment lighting - ISO 4049: All results are within the range specified by ISO 4049.
- Depth of Cure - ISO 4049: 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: 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: 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: All results are greater than the specified threshold, therefore the material is considered as conformant.
- Water sorption and solubility. - ISO 4049: The results demonstrate that the product complies the specification in the EN ISO 4049 Standard.
- Accelerated Stability Studies: 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): 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.
- Filler particle size distribution (microns): The test results demonstrate the microns within the specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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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
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,
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
2
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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3
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
4
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 EVOCERAM | |
| BULK FILL | IVOCLAR | ||
| VIVADENT AG | |||
| Reference | K150393 | TETRIC EVOFLOW | |
| BULK FILL | IVOCLAR | ||
| VIVADENT 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 Fill | ||
| Flow APS | TETRIC EVOFLOW BULK FILL | |
| TETRIC EVOCERAM BULK FILL | Discussion | |
| 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 | Tetric Evoceram Bulk Fill (Predicate) | |
| – Restoration of Deciduous teeth | ||
| – Restorations in the posterior region | ||
| (Classes I and II) | ||
| – Class V restorations (cervical caries, root | ||
| erosion, wedge-shaped defects) | ||
| – Extended fissure sealing in molars and | ||
| premolars | ||
| Tetric Evoflow Bulk Fill (Reference) | ||
| – As initial layer / first increment in Class I | ||
| and II composite restorations in | ||
| permanent teeth | ||
| – Restorations in deciduous teeth | Opus Bulk Fill APS x Tetric Evoceram Bulk Fill | |
| Reconstructive build-up, base and lining of direct | ||
| restorations, repair of small defects of the enamel and | ||
| repair of temporary acrylic and resin materials are | ||
| examples of direct restauration. As a conclusion, the | ||
| subject and the predicate have the same indication of | ||
| use. | ||
| Opus Bulk Fill Flow APS x Tetric Evoflow Bulk Fill | ||
| – Base/lining: are the restorations made under other | ||
| restorative material, such as initial layer. This main | ||
| indication has as examples: Tunnel-type preparation, | ||
| Planning of preparation walls and Core build-up. | ||
| – Small, non occlusal stress-bearing class I restorations | ||
| according to minimally invasive filling therapy: | ||
| restorations made in regions that do not receive direct | ||
| masticatory load, according to a minimally invasive | ||
| therapy. | ||
| The following indications are related to this definition: | ||
| Pit and fissure sealant, Repair of enamel defects, | ||
| Bonding of tooth fragments, Repair in composite resin | ||
| and Non-carious cervical lesions. | ||
| Since the product Tetric Evoflow Bulk Fill is indicated for | ||
| restorations in deciduous teeth, not limiting your use as | ||
| initial layer, it's imply the material can be applied in | ||
| occlusal surface in this situation. Taking into account | ||
| that the deciduous dentition receives a lower | ||
| masticatory load, the situation of these indications | ||
| mentioned above in permanent teeth fits in the same | ||
| situation. | ||
| Restorations are clinical known for indication to | ||
| permanent 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 Manufacturer
and Common Name | Opus Bulk Fill APS and
Opus Bulk Fill Flow
APS
Dentscare | TETRIC EVOCERAM BULK FILL
IVOCLAR VIVADENT AG
(Predicate) | TETRIC EVOFLOW BULK FILL
IVOCLAR 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 Resin
Material | 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 and
authorized laboratories
and clinics.
Opus Bulk Fill APS and
Opus Bulk Fill Flow APS
must be stored in
temperatures between 5°
to 27°C. | Dental prosthetics and authorized
laboratories and clinics.
TETRIC must be stored in
temperatures between 2° to 28°C | Dental prosthetics and authorized
laboratories and clinics.
TETRIC must be stored in
temperatures between 2° to 28°C |
| Applicable
Standards | ISO 4049 ; ISO 10993-1 | ISO 4049; ISO 10993-1 | ISO 4049; ISO 10993-1 |
| Device Sterilization | Not Applicable | Not Applicable | Not Applicable |
| Primary Package
Container : | Syringe and Capsule | Syringe and Capsule | Syringe and Capsule |
| Shelf life | 2 years | Not declared | Not declared |
| Use the same
materials or
substances in
contact with the
same human tissues
or body fluids? | YES | YES | YES |
| Is the product in
compliance to
EN 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 the
same clinical
condition? | yes | yes | yes |
| Is it used at the
same site in the
body? | yes | yes | yes |
| Is it used in a
similar population? | yes | yes | yes |
| Is it used for the
same intended
purpose? | yes | yes | yes |
| Is not foreseen to
deliver significantly
different
performances? | no | no | no |
| Is it similar
conditions of use? | yes | yes | yes |
| Is it similar
specifications and
properties | yes | yes | yes |
| Is it similar
principles of
operation? | | | |
| | 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.
8
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 specimen
and determine the corresponding value of
aluminium, δа. | |
| Flexing
Resistance - ISO
4049 | According to the EN ISO 4049 standard the
specification for flexural strength is
≥80MPa. | 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. |
| Accelerated
Stability Studies | Study created to accelerate the possible
chemical degradation and/or physical
changes of the product in forced conditions
of storage. | 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. |
| Evaluation
Report Of Long-
Term Stability
(Shelf) | Study designed to verify the physical and
chemical characteristics of the product
during the expected shelf life. The results
are used to confirm the 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. |
| Fluoride release | Evaluation of fluoride release rate in
solution after 7 days in the oven at 37o C | The results of the fluoride release assay
demonstrate no release of fluoride ions. |
| Intensity and
wavelength for
photocuring | Study designed to evaluate the curing
depth using photopolymerizes with
different wavelengths and power density | The test results demonstrate the ability
polymerization resin with differencing light
devices. |
| Filler particle
size distribution
(microns) | Study designed to verify the grainsize
analysis and optical characteristics. | The test results demonstrate the microns
within 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 |
|---|---|---|
| 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: | 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. |
| | 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; | The results demonstrate that the
product meets ISO 4049. |
| | 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%. | |
| 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
value for the δs thickness of the specimen
and determine the corresponding value of
aluminium, δа. | 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 | 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 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. |
| Accelerated
Stability Studies | Study created to accelerate the possible
chemical degradation and/or physical
changes of the product in forced conditions
of storage. | 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- | Study designed to verify the physical and
chemical characteristics of the product
during the expected shelf life. The results | We don't have any conclusive data
about shelf life yet. At the moment we
are using the estimated shelf life in 2 |
| Term Stability
(Shelf) | are used to confirm the expiration date
and storage conditions. | years in the storage condition of 27 ° C,
based on no accelerated stability test. |
| Filler particle
size
distribution
(microns) | Study designed to verify the grainsize
analysis and optical characteristics. | The test results demonstrate the
microns 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
13
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.