(323 days)
No
The device description and performance studies focus on the physical and chemical properties of dental cements and composites, with no mention of AI or ML.
Yes.
The device is used for cementing orthodontic bands and temporary dental disocclusion, which are therapeutic interventions within dentistry to align teeth or manage occlusion.
No
The devices described (Orthocem and Ortho Bite) are cements used for bonding orthodontic brackets and bands, respectively. Their function is to physically attach these dental appliances. They do not perform any diagnostic function, such as identifying a disease, condition, or physiological state.
No
The device description clearly describes physical materials (cement and composite) and their physical properties, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of both Orthocem and Ortho Bite is for the cementation of orthodontic appliances (brackets, tubes, bands) to teeth and for temporary dental disocclusion. This is a direct application within the oral cavity for a therapeutic purpose (orthodontic treatment).
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details the composition and properties of the cements, all related to their function as adhesives and temporary occlusal adjustments within the mouth.
- Anatomical Site: The anatomical site is the oral cavity, specifically the teeth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition by analyzing samples from the body.
The device is a dental material used for bonding and temporary adjustments during orthodontic treatment, which falls under the category of a dental device rather than an IVD.
N/A
Intended Use / Indications for Use
Orthocem: Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface.
Ortho bite: The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
DYH, EBF
Device Description
Orthocem: Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product 's removal from teeth, after removing brackets.
Ortho Bite: Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. Its composition includes dimethacrylate monomers, HEMA Phosphate, traditional Camphorquinone/DABE system as photoinitiator and silica as load particle. The combination of silica load fillers with the dimethacrylate monomer composition results in a viscosity that allows it to be handled and applied without running off the application area. The presence of HEMA Phosphate allows adhesion to the enamel surface, which is a known feature of composite cements indicated for bracket bonding. The thixotropy allows the product to have self-levelling capability, known as a shear thinning property that makes the composite settle correctly on the occlusal surface. The product is colored in order to facilitate its identification during application and removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, tooth; Enamel and Dentin
Indicated Patient Age Range
Adults
Intended User / Care Setting
Dental prosthetics and authorized laboratories and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
ORTHOCEM:
- 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.
- Flexural strength: All results are greater than the specified threshold, therefore the material is considered to be in conformity.
- Water sorption and solubility: 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 183 days test period, the shelf-life of 2 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 24 months of the long-term test (shelf), the shelf life of 2 years in the storage condition of 30°C for the product can be confirmed.
- Transport evaluation report: The testing results were successful and we had only aesthetic damages considered irrelevant. However, initially the test report advised that the packages did not meet the minimum criteria for compression testing. Therefore, a new testing was performed aiming to re-evaluate the paperboard compression resistance. DENTSCARE modified the paperboard specs and submitted to CETEA to repeat the assessment. According to TEST REPORT CETEA RE 07.217/17, all evaluated samples met the compression criteria required by ASTM D4169 standard.
- Shear Bond Strength - ISO 29022: Orthocem: 14.70 MPa; Ortho Bite: 14.76 MPa; Transbond XT: 15.44 MPa
ORTHO BITE:
- 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.
- Flexural strength: All results are greater than the specified threshold, therefore the material is considered to be in conformity.
- Water sorption and solubility.: 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 227 days test period, the shelf-life of 3 years in the storage condition of 27°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.
- Transport evaluation report: The testing results were successful and we had only aesthetic damages considered irrelevant. However, initially the test report advised that the packages did not meet the minimum criteria for compression testing. Therefore, a new testing was performed aiming to re-evaluate the paperboard compression resistance. DENTSCARE modified the paperboard specs and submitted to CETEA to repeat the assessment. According to TEST REPORT CETEA RE 07.217/17, all evaluated samples met the compression criteria required by ASTM D4169 standard.
- Shear Bond Strength - ISO 29022: Orthocem: 14.70 MPa; Ortho Bite: 14.76 MPa; Transbond XT: 15.44 MPa
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
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 14, 2020
Dentscare Ltda % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K192682
Trade/Device Name: Orthocem, Ortho Bite Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin And Tooth Conditioner Regulatory Class: Class II Product Code: DYH, EBF Dated: July 14, 2020 Received: July 20, 2020
Dear Rodrigo Abreu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192682
Device Name Orthocem and Ortho Bite
Indications for Use (Describe)
Orthocem
Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface.
Ortho bite
The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment.
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/1 description: The image contains a logo for a company called DentsCare. The logo features a stylized letter "D" with horizontal lines inside it, placed above the word "DentsCare" in a sans-serif font. To the right of the logo, there is text that includes the company's address, which is "AV. SAN MARTIN 1050", and a phone number, which is "Ph: 4450-7000".
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
Tel.: +55 (47) 34416131
Email: roberta.uyara@fgm.ind.br
- E) Most Recent Revision Date: August 12, 2020
- F) Classification Name: Bracket adhesive resin and tooth conditioner
Common / Usual Name: Bracket adhesive resin and tooth conditioner
Proprietary Name: Orthocem and Ortho Bite
Product Code: DYH and EBF
Class: Class II
Regulation: 21 CFR 872.3750
G) Device Description
Orthocem
Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product 's removal from teeth, after removing brackets.
Ortho Bite
Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. Its composition includes dimethacrylate monomers, HEMA Phosphate, traditional Camphorquinone/DABE system as photoinitiator and silica as load particle. The combination of silica load fillers with the dimethacrylate monomer composition results in a viscosity that allows it to be handled and applied without running off the application area. The presence of HEMA Phosphate allows adhesion to the enamel surface, which is a known feature of composite cements indicated for
4
Image /page/4/Picture/1 description: The image shows the logo for DentsCare. The logo features a stylized letter 'D' with three horizontal lines inside it, resembling waves or airflow. Below the symbol, the word 'DentsCare' is written in a stylized font, with the 'Dents' part in a darker shade and 'Care' in a lighter shade. The overall design is clean and professional, suggesting a company related to dental care or hygiene.
ITSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
bracket bonding. The thixotropy allows the product to have self-levelling capability, known as a shear thinning property that makes the composite settle correctly on the occlusal surface. The product is colored in order to facilitate its identification during application and removal.
H) Substantial Equivalence:
The Orthocem and Ortho Bite are equivalent with the following products:
| 510(k) Number | Model | Company |
|---|---|---|
| K880393 | Transbond™ XT | 3M Unitek |
| (primary predicate) |
I) Secondary Predicate:
| 510(k) Number | Model | Company |
|---|---|---|
| K924151 | Bisco D/C Resinomer (Ultra | |
| Band-Lok) | BISCO, INC. (Reliance | |
| Orthodontic Products, Inc. as | ||
| Repackager/Relabeler; | ||
| Specification Developer) |
5
Image /page/5/Picture/1 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with three horizontal lines inside. The contact information includes the address "AV. EDGAR NELSON MEISTER, 474" and the phone number "Ph: 55 - 47 - 3441-6131".
J) Indication for Use:
| Indication for Use Comparison | ||
|---|---|---|
| Orthocem and Ortho Bite | Transbond™ XT | Bisco D/C Resinomer (Ultra |
| Band-Lok) | ||
| Orthocem | ||
| Cementation of metal, ceramic or | ||
| polycarbonate brackets or tubes to enamel | ||
| surface. | Intended for direct bonding of ceramic | |
| brackets and metal brackets. | Ultra Band-Lok® is intended for use | |
| as an orthodontic band cement and | ||
| for occlusal buildups. | ||
| Ortho bite | ||
| The product is indicated for cementing | ||
| orthodontic bands and is also suitable for | ||
| temporary dental disocclusion during | ||
| orthodontic treatment. |
K) Technological Characteristics Comparison:
The predicate and reference devices used to establish equivalence for the Orthocem and Ortho Bite device are outlined below. This section of this submission will provide a comparison of dechnical specifications of the Orthocem and Ortho Bite to each of the predicate devices stratified by functional modality.
| Device Manufacturer
and Common Name | Orthocem and Ortho Bite
DentsCare | Transbond™ XT
3M Unitek | Ultra Band-Lok
(Bisco D/C Resinomer)
Reliance Orthodontic Products
Inc. |
|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| 510k # | K192682 | K880393 | K924151 |
| Classification | Class II | Class II | Class II |
| Regulation # | 21 CFR 872.3750 | 21 CFR 872.3750 | 21 CFR 872.3690 |
| Product Code | DYH, EBF | DYH | EBF |
| Classification Name | Bracket adhesive resin and tooth
conditioner
Tooth shade resin material | Bracket adhesive resin and tooth
conditioner | Tooth shade resin material |
| Patient Population | Adults | Adults | Adults |
| Prescription Use | RX only | RX only | RX only |
| Environment | Dental prosthetics and
authorized laboratories and
clinics.
Orthocem must be stored in
temperatures between 5° to
30°C.
Ortho Bite must be stored in
temperatures between 5° to
27°C. | Dental prosthetics and authorized
laboratories and clinics.
Transbond™ XT must be stored in
temperatures between 2° to 27°C. | Dental prosthetics and
authorized laboratories and
clinics.
Ultra Band-Lok must be stored
at room temperature (15-
30°C). |
| Applicable Standards | ISO 4049; ISO 29022; ISO
10993 | Not Available, details not disclosed
by manufacturer. | Not Available, details not
disclosed by manufacturer. |
| Base Composition | The adhesives contain
methacrylate as resin fillers and
silica that is used as fillers. | The adhesive contains
methacrylate as resin fillers and
silica that is used as fillers. | The adhesive contains
methacrylate as resin fillers
and silica that is used as
fillers. |
| Device Sterilization | Not Applicable | Not Applicable | Not Applicable |
| Primary Package
Container: | Capsule, Syringe | Capsule, Syringe | Syringe |
| Shelf life | Orthocem: 2 years
Ortho Bite: 3 years | Not Available, details not disclosed
by manufacturer. | Not Available, details not
disclosed by manufacturer. |
| 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 |
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Image /page/6/Picture/1 description: The image contains a logo for a company called DentsCare. The logo features a stylized letter "D" with three horizontal lines inside it, resembling water waves. Below the symbol, the word "DentsCare" is written in a sans-serif font, with the "D" in a larger size than the rest of the letters.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
7
Image /page/7/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 inside the "D" to represent teeth. Below the symbol, the word "DentsCare" is written in a bold, sans-serif font, also in the same muted blue-gray color.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
Page 05 of 09
| Reusable | NO | NO | NO |
|---|---|---|---|
| Duration | Permanent | Permanent | Permanent |
| Part of body | Oral, tooth | Oral, tooth | Oral, tooth |
| 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 |
| Orthocem | Ortho Bite | Transbond XT | Ultra Band-Lok | |
|---|---|---|---|---|
| Sensitivity to ambient | ||||
| light | Physically | |||
| homogeneous | Physically | |||
| homogeneous | Physically homogeneous | Not disclosed by the | ||
| manufacturer1 | ||||
| Depth of cure | 2.830 mm | 2.993 mm | 2.993 mm | Not disclosed by the |
| manufacturer1 | ||||
| Flexural strength | 82.01 MPa | 118.30 MPa | 142.30 MPa | Not disclosed by the |
| manufacturer1 |
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Image /page/8/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 address 'AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL' and the phone number 'Ph: 55 - 47 - 3441-6131'.
Page 06 of 09
| Water sorption and solubility | Sorption: 31.43 µg/mm³
Solubility: 5.66 µg/mm³ | Sorption: 30.16 µg/mm³
Solubility: 5.76 µg/mm³ | Sorption: 25.13 µg/mm³
Solubility: 5.50 µg/mm³ | Not disclosed by the manufacturer¹ |
|---------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------|------------------------------------|
| Shear Bond Strength - ISO 29022 | 14.70 MPa | 14.76 MPa | 15.44 MPa | Not disclosed by the manufacturer¹ |
4 According to the product code classification, EBF, the product should meet the recognized consensus standards ISO 29022, ISO 10993 and ISO 4049, that are the same normatives considered for Orthocem and Ortho Bite.
Substantial Equivalence Discussion:
Despite the indications for use statement for Ortho Bite are not identical to the predicate in that the subject devices include additional indication of bonding of tubes and wording is slightly different, the differences do not alter the intended use of the device relative to the predicate, since all devices have intended use, that is to be used as a bonding agent for orthodontic appliances.
Regarding the indication for temporary dental disocclusion during orthodontic treatment, that is an additional and exclusive indication to the subject device Ortho Bite, this intended use is similar that of the reference device, Ultra Band-Lok. The use of these materials is a common method to create mini-biteplane in daily orthodontic practice.
The subject devices are similar to the predicate devices in that they are all light-curing resin cementation of orthodontic pieces. The subject devices and the predicate devices have substantially equivalent of indications for use, shelf life, physical, technological and mechanical properties. As depicted above, the flexural strength between the subject devices and predicate device demonstrate higher value for the predicate device. This difference does not affect the substantial equivalence, since all products, including the reference device, meet the same recognized standards. The subject devices are slightly different from the predicate and reference devices, they contain the same key biocompatible inqredients, but in different proportions. The biocompatibility test reports this difference and it does not affect the substantial equivalence.
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Page 07 of 09
Image /page/9/Picture/1 description: The image shows a logo for DentsCare. The logo features a stylized letter "D" in a gray color. Inside the "D", there are three horizontal lines that resemble waves or airflow. The text "DentsCare" is partially visible below the logo, suggesting it is the name of the company or service.
L) Applicable Standards:
In order to reach substantially equivalent to the predicate device Orthocem and Ortho Bite was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry.
ISO 4049 - Dentistry - Polymer-based restorative materials
ISO 10993-1 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ENISO 10993-1:2009)
ISO 29022 - Dentistry -- Adhesion -- Notched-edge shear bond strength test
Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device Orthocem and Ortho Bite demonstrate equivalency to the predicates above.
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Page 08 of 09
Image /page/10/Picture/1 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color. Inside the "D", there are three horizontal lines that appear to represent movement or flow. Below the "D", the word "DentsCare" is written in a simple, sans-serif font, also in the same muted blue-gray color.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL 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 test results summary please see below.
ORTHOCEM
| 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 |
-
|
| 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. |
| Flexural
strength | According to the EN ISO 4049 standard the
specification for flexural strength is
≥50MPa. | All results are greater than the specified
threshold, therefore the material is considered to
be in conformity |
| Water
sorption and
solubility | Sorption: Maximum of 40 µg/mm³.
Solubility: maximum of 7.5 µg/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 183 days test period, the shelf-life of 2 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 24 months of the long-term test (shelf), the
shelf life of 2 years in the storage condition of
30°C for the product can be confirmed. |
| Transport
evaluation
report | We performed a testing according to ASTM
D4169 | The testing results were successful and we had
only aesthetic damages considered irrelevant.
However, initially the test report advised that the
packages did not meet the minimum criteria for
compression testing. Therefore, a new testing
was performed aiming to re-evaluate the
paperboard compression resistance. DENTSCARE
modified the paperboard specs and submitted to
CETEA to repeat the assessment. According to
TEST REPORT CETEA RE 07.217/17, all evaluated
samples met the compression criteria required by
ASTM D4169 standard. |
| Shear Bond
Strength -
ISO 29022 | According to ISO 29022 standard, the test
verifies the adhesive bond strength between
direct dental restorative materials and tooth
structure. The results are used to confirm
the adhesion of the product to the teeth | Orthocem: 14.70 MPa
Ortho Bite: 14.76 MPa
Transbond XT: 15.44 MPa |
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Image /page/11/Picture/1 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 that resemble waves. Below the symbol is the text "DentsCare" in a sans-serif font, also in gray.
DENTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
ORTHO BITE
| 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. |
| Flexural
strength | According to the EN ISO 4049 standard the
specification for flexural strength is
≥50MPa. | All results are greater than the specified
threshold, therefore the material is considered
to be in conformity. |
| Water
sorption and
solubility. | Sorption: Maximum of 40 µg/mm3.
Solubility: maximum of 7.5 µg/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 227 days test period, the shelf-life of 3
years in the storage condition of 27°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. |
| Transport
evaluation
report | We performed a testing according to ASTM
D4169 | The testing results were successful and we
had only aesthetic damages considered
irrelevant. However, initially the test report
advised that the packages did not meet the
minimum criteria for compression testing.
Therefore, a new testing was performed
aiming to re-evaluate the paperboard
compression resistance. DENTSCARE modified
the paperboard specs and submitted to CETEA
to repeat the assessment. According to TEST
REPORT CETEA RE 07.217/17, all evaluated
samples met the compression criteria required
by ASTM D4169 standard. |
| Shear Bond
Strength -
ISO 29022 | According to ISO 29022 standard, the test
verifies the adhesive bond strength between
direct dental restorative materials and tooth
structure. The results are used to confirm
the adhesion of the product to the teeth
surface. | Orthocem: 14.70 MPa
Ortho Bite: 14.76 MPa
Transbond XT: 15.44 MPa |
Conclusion: Based on the performance test applied to these Orthocem and Ortho Bite and the predicate comparison, we conclude that the subject devices are substantial equivalent with the predicate.