(323 days)
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.
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 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.
The provided document is a 510(k) Premarket Notification from the FDA for two dental adhesive devices, "Orthocem" and "Ortho Bite". It details the equivalence to predicate devices based on non-clinical testing of material properties, not a study involving AI or human readers for diagnostic performance. Therefore, many of the questions related to AI-specific evaluation metrics, human expert involvement, and clinical study design (like MRMC, effect size, training/test sets for AI, and adjudication) are not applicable to this submission.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based only on the information available in the provided text:
Key Takeaway: This 510(k) submission focuses on demonstrating substantial equivalence of dental materials based on physical, chemical, and mechanical properties, not on AI-driven diagnostic performance or human reader studies. The "study" mentioned refers to non-clinical laboratory tests.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally derived from recognized international standards like ISO 4049, ISO 10993, and ISO 29022. The reported device performance is compared against these standards.
| Test / Property | Acceptance Criteria (Specification) | Orthocem Performance (Results) | Ortho Bite Performance (Results) |
|---|---|---|---|
| Sensitivity to Ambient Lighting (ISO 4049) | Physical homogeneity of the sample; no difference compared to unexposed material. | All results within the range specified by ISO 4049. | All results within the range specified by ISO 4049. |
| Depth of Cure (ISO 4049) | > 1.0 mm for opaque materials, > 1.5 mm for non-opaque materials. | All results greater than the specified threshold. | All results greater than the specified threshold. |
| Flexural Strength (EN ISO 4049) | ≥ 50 MPa | 82.01 MPa (Table on page 7), All results greater than the specified threshold (page 10). | 118.30 MPa (Table on page 7), All results greater than the specified threshold (page 11). |
| Water Sorption | Maximum of 40 µg/mm³ | 31.43 µg/mm³ (Table on page 8), Complies with EN ISO 4049 Standard (page 10). | 30.16 µg/mm³ (Table on page 8), Complies with EN ISO 4049 Standard (page 11). |
| Water Solubility | Maximum of 7.5 µg/mm³ | 5.66 µg/mm³ (Table on page 8), Complies with EN ISO 4049 Standard (page 10). | 5.76 µg/mm³ (Table on page 8), Complies with EN ISO 4049 Standard (page 11). |
| Shear Bond Strength (ISO 29022) | Test verifies adhesive bond strength; no specific numerical acceptance criterion stated, but compared to predicate. | 14.70 MPa (Table on page 8, also reported on page 10 and 11). | 14.76 MPa (Table on page 8, also reported on page 10 and 11). |
| Accelerated Stability Studies | Study to accelerate chemical degradation/physical changes in forced conditions. | Confirms 2-year shelf-life at 30°C. | Confirms 3-year shelf-life at 27°C. |
| Long-Term Stability (Shelf-Life) | Verify physical/chemical characteristics during expected shelf life to confirm expiration date and storage. | Confirms 2-year shelf-life at 30°C. | Confirms 3-year shelf-life at 30°C. |
| Transport Evaluation Report | Testing according to ASTM D4169. | All evaluated samples met the compression criteria required by ASTM D4169 standard. | All evaluated samples met the compression criteria required by ASTM D4169 standard. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the numerical sample sizes for each non-clinical test (e.g., how many specimens were used for flexural strength tests). It refers to the tests performed "according to the table below" for performance studies.
- Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured product samples, not on patient data. The manufacturer, DENTSCARE LTDA, is based in Brazil (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL). The tests generated prospective data (i.e., designed experiments to evaluate product properties).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the "test set" consists of non-clinical material samples, not patient data requiring expert interpretation (e.g., radiology images). The ground truth is established by the physical and chemical properties of the materials themselves, measured by standardized laboratory methods.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., radiologist reads) in clinical studies. For physical material tests, results are objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not applicable. This submission is for dental adhesive materials, not an AI-assisted diagnostic device. No MRMC study was performed, and human reader performance with or without AI assistance is not relevant to this device's evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a material, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by physical, chemical, and mechanical measurements of the material properties according to recognized international standards (e.g., ISO 4049, ISO 29022, ISO 10993). This is typically performed through controlled laboratory testing.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in the context of demonstrating substantial equivalence for dental materials based on physical properties. The "training" for the device's formulation would occur during its research and development phase, but not as part of a formal "training set" for regulatory evaluation in the way AI models are trained.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of this device's regulatory evaluation. The development of the dental adhesive formulation (the "training" of the product itself) would rely on material science principles and iterative laboratory testing to achieve desired properties, rather than a "ground truth" derived from patient data or expert consensus.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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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,
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
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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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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
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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 (UltraBand-Lok) | BISCO, INC. (RelianceOrthodontic Products, Inc. asRepackager/Relabeler;Specification Developer) |
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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 (UltraBand-Lok) |
| OrthocemCementation of metal, ceramic orpolycarbonate brackets or tubes to enamelsurface. | Intended for direct bonding of ceramicbrackets and metal brackets. | Ultra Band-Lok® is intended for useas an orthodontic band cement andfor occlusal buildups. |
| Ortho biteThe product is indicated for cementingorthodontic bands and is also suitable fortemporary dental disocclusion duringorthodontic 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 Manufacturerand Common Name | Orthocem and Ortho BiteDentsCare | Transbond™ XT3M Unitek | Ultra Band-Lok(Bisco D/C Resinomer)Reliance Orthodontic ProductsInc. |
|---|---|---|---|
| 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 toothconditionerTooth shade resin material | Bracket adhesive resin and toothconditioner | Tooth shade resin material |
| Patient Population | Adults | Adults | Adults |
| Prescription Use | RX only | RX only | RX only |
| Environment | Dental prosthetics andauthorized laboratories andclinics.Orthocem must be stored intemperatures between 5° to30°C.Ortho Bite must be stored intemperatures between 5° to27°C. | Dental prosthetics and authorizedlaboratories and clinics.Transbond™ XT must be stored intemperatures between 2° to 27°C. | Dental prosthetics andauthorized laboratories andclinics.Ultra Band-Lok must be storedat room temperature (15-30°C). |
| Applicable Standards | ISO 4049; ISO 29022; ISO10993 | Not Available, details not disclosedby manufacturer. | Not Available, details notdisclosed by manufacturer. |
| Base Composition | The adhesives containmethacrylate as resin fillers andsilica that is used as fillers. | The adhesive containsmethacrylate as resin fillers andsilica that is used as fillers. | The adhesive containsmethacrylate as resin fillersand silica that is used asfillers. |
| Device Sterilization | Not Applicable | Not Applicable | Not Applicable |
| Primary PackageContainer: | Capsule, Syringe | Capsule, Syringe | Syringe |
| Shelf life | Orthocem: 2 yearsOrtho Bite: 3 years | Not Available, details not disclosedby manufacturer. | Not Available, details notdisclosed by manufacturer. |
| Use the samematerials orsubstances in contactwith the same humantissuesor body fluids? | YES | YES | YES |
| Is the product incompliance to EN ISO10993? | 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
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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 thesame clinicalcondition? | YES | YES | YES |
| Is it used at the samesite in the body? | YES | YES | YES |
| Is it used in a similarpopulation? | YES | YES | YES |
| Is it used for thesame intendedpurpose? | YES | YES | YES |
| Is not foreseen todeliver significantlydifferentperformances? | NO | NO | NO |
| Is it similar conditionsof use? | YES | YES | YES |
| Is it similarspecifications andproperties | YES | YES | YES |
| Is it similar principlesof operation? | YES | YES | YES |
| Orthocem | Ortho Bite | Transbond XT | Ultra Band-Lok | |
|---|---|---|---|---|
| Sensitivity to ambientlight | Physicallyhomogeneous | Physicallyhomogeneous | Physically homogeneous | Not disclosed by themanufacturer1 |
| Depth of cure | 2.830 mm | 2.993 mm | 2.993 mm | Not disclosed by themanufacturer1 |
| Flexural strength | 82.01 MPa | 118.30 MPa | 142.30 MPa | Not disclosed by themanufacturer1 |
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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/mm³Solubility: 5.66 µg/mm³ | Sorption: 30.16 µg/mm³Solubility: 5.76 µg/mm³ | Sorption: 25.13 µg/mm³Solubility: 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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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 toenvironmentlighting - ISO4049 | According to the ISO 4049 standard,acceptance is related to the physicalhomogeneity of the sample, so the materialwas compared after the test to the samematerial pressed between coverslips, butwithout exposure to ambient light. Thus,there is no difference between the samples. | All results are within the range specified by ISO4049. |
| Depth of Cure- ISO 4049 | According to ISO 4049, the specification forthis material is that its curing depth is: >1.0 mm for opaque materials and > 1.5 mmfor non-opaque materials. | All results are greater than the specifiedthreshold, therefore the material is considered tobe in conformity. |
| Flexuralstrength | According to the EN ISO 4049 standard thespecification for flexural strength is≥50MPa. | All results are greater than the specifiedthreshold, therefore the material is considered tobe in conformity |
| Watersorption andsolubility | Sorption: Maximum of 40 µg/mm³.Solubility: maximum of 7.5 µg/mm³. | The results demonstrate that the productcomplies the specification in the EN ISO 4049Standard. |
| AcceleratedStabilityStudies | Study created to accelerate the possiblechemical degradation and/or physicalchanges of the product in forced conditionsof storage. | Considering the results observed at the end ofthe 183 days test period, the shelf-life of 2 yearsin the storage condition of 30°C for the productcan be confirmed. |
| EvaluationReport ofLong-TermStability(Shelf) | Study designed to verify the physical andchemical characteristics of the productduring the expected shelf life. The resultsare used to confirm the expiration date andstorage conditions. | Considering the results observed at the end ofthe 24 months of the long-term test (shelf), theshelf life of 2 years in the storage condition of30°C for the product can be confirmed. |
| Transportevaluationreport | We performed a testing according to ASTMD4169 | The testing results were successful and we hadonly aesthetic damages considered irrelevant.However, initially the test report advised that thepackages did not meet the minimum criteria forcompression testing. Therefore, a new testingwas performed aiming to re-evaluate thepaperboard compression resistance. DENTSCAREmodified the paperboard specs and submitted toCETEA to repeat the assessment. According toTEST REPORT CETEA RE 07.217/17, all evaluatedsamples met the compression criteria required byASTM D4169 standard. |
| Shear BondStrength -ISO 29022 | According to ISO 29022 standard, the testverifies the adhesive bond strength betweendirect dental restorative materials and toothstructure. The results are used to confirmthe adhesion of the product to the teeth | Orthocem: 14.70 MPaOrtho Bite: 14.76 MPaTransbond XT: 15.44 MPa |
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Page 09 of 09
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 toenvironmentlighting - ISO4049 | According to the ISO 4049 standard,acceptance is related to the physicalhomogeneity of the sample, so the materialwas compared after the test to the samematerial pressed between coverslips, butwithout exposure to ambient light. Thus,there is no difference between the samples. | All results are within the range specified byISO 4049. |
| Depth of Cure- ISO 4049 | According to ISO 4049, the specification forthis material is that its curing depth is: >1.0 mm for opaque materials and > 1.5 mmfor non-opaque materials. | All results are greater than the specifiedthreshold, therefore the material is consideredto be in conformity. |
| Flexuralstrength | According to the EN ISO 4049 standard thespecification for flexural strength is≥50MPa. | All results are greater than the specifiedthreshold, therefore the material is consideredto be in conformity. |
| Watersorption andsolubility. | Sorption: Maximum of 40 µg/mm3.Solubility: maximum of 7.5 µg/mm3. | The results demonstrate that the productcomplies the specification in the EN ISO 4049Standard. |
| AcceleratedStabilityStudies | Study created to accelerate the possiblechemical degradation and/or physicalchanges of the product in forced conditionsof storage. | Considering the results observed at the end ofthe 227 days test period, the shelf-life of 3years in the storage condition of 27°C for theproduct can be confirmed. |
| EvaluationReport ofLong-TermStability(Shelf) | Study designed to verify the physical andchemical characteristics of the productduring the expected shelf life. The resultsare used to confirm the expiration date andstorage conditions. | Considering the results observed at the end ofthe 36 months of the long-term test (shelf),the shelf life of 3 years in the storagecondition of 30°C for the product can beconfirmed. |
| Transportevaluationreport | We performed a testing according to ASTMD4169 | The testing results were successful and wehad only aesthetic damages consideredirrelevant. However, initially the test reportadvised that the packages did not meet theminimum criteria for compression testing.Therefore, a new testing was performedaiming to re-evaluate the paperboardcompression resistance. DENTSCARE modifiedthe paperboard specs and submitted to CETEAto repeat the assessment. According to TESTREPORT CETEA RE 07.217/17, all evaluatedsamples met the compression criteria requiredby ASTM D4169 standard. |
| Shear BondStrength -ISO 29022 | According to ISO 29022 standard, the testverifies the adhesive bond strength betweendirect dental restorative materials and toothstructure. The results are used to confirmthe adhesion of the product to the teethsurface. | Orthocem: 14.70 MPaOrtho Bite: 14.76 MPaTransbond 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.
§ 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.