Orthocem, Ortho Bite

K192682 · Dentscare Ltda · DYH · Aug 14, 2020 · Dental

Device Facts

• Record ID: K192682
• Device Name: Orthocem, Ortho Bite
• Applicant: Dentscare Ltda
• Product Code: DYH · Dental
• Decision Date: Aug 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Orthocem and Ortho Bite are light-curing resin cements used in orthodontic procedures. Orthocem bonds metal, ceramic, or polycarbonate brackets/tubes to enamel; it contains a fluorescent substance for UV-light tracing during removal. Ortho Bite is a self-adhesive, self-levelling composite used for cementing orthodontic bands and creating temporary bite-planes (disocclusion). Both devices are applied by dental professionals in clinical settings. They utilize dimethacrylate monomers, HEMA Phosphate, silica fillers, and a Camphorquinone/DABE photoinitiator system. The materials are applied to the tooth surface and cured via light exposure. The clinician uses the physical properties—thixotropy for Ortho Bite and fluorescence for Orthocem—to ensure proper placement and subsequent removal. These devices facilitate orthodontic treatment by securing appliances and managing occlusal interference, benefiting the patient through effective appliance retention and controlled tooth movement.

Clinical Evidence

Bench testing only. Evaluated per ISO 4049 (depth of cure, flexural strength, water sorption/solubility, sensitivity to ambient light) and ISO 29022 (shear bond strength). Results: Orthocem (14.70 MPa) and Ortho Bite (14.76 MPa) compared to Transbond XT (15.44 MPa). Stability and transport testing (ASTM D4169) confirmed shelf-life (2 years for Orthocem, 3 years for Ortho Bite) and packaging integrity.

Technological Characteristics

Light-curing resin cements. Composition: dimethacrylate monomers, HEMA Phosphate, silica fillers, Camphorquinone/DABE photoinitiator. Form factor: syringe/capsule. Standards: ISO 4049 (polymer-based restorative materials), ISO 29022 (shear bond strength), ISO 10993 (biocompatibility). Non-sterile. Storage: 5-30°C (Orthocem), 5-27°C (Ortho Bite).

Indications for Use

Indicated for adults requiring orthodontic treatment, specifically for the cementation of metal, ceramic, or polycarbonate brackets, tubes, and orthodontic bands, as well as for temporary dental disocclusion.

Regulatory Classification

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.

Predicate Devices

• Transbond™ XT (K880393)

Reference Devices

• Bisco D/C Resinomer (Ultra Band-Lok) (K924151)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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".

K192682

### 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: [phone]

- D) Contact Person:
Roberta

Tel.: [phone]

Email: [e-mail]

- 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

K192682

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<br>Band-Lok) | BISCO, INC. (Reliance<br>Orthodontic Products, Inc. as<br>Repackager/Relabeler;<br>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 (Ultra<br>Band-Lok) |
| <b>Orthocem</b><br>Cementation of metal, ceramic or<br>polycarbonate brackets or tubes to enamel<br>surface. | Intended for direct bonding of ceramic<br>brackets and metal brackets. | Ultra Band-Lok® is intended for use<br>as an orthodontic band cement and<br>for occlusal buildups. |
| <b>Ortho bite</b><br>The product is indicated for cementing<br>orthodontic bands and is also suitable for<br>temporary dental disocclusion during<br>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<br>and Common Name | Orthocem and Ortho Bite<br>DentsCare | Transbond™ XT<br>3M Unitek | Ultra Band-Lok<br>(Bisco D/C Resinomer)<br>Reliance Orthodontic Products<br>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<br>conditioner<br>Tooth shade resin material | Bracket adhesive resin and tooth<br>conditioner | Tooth shade resin material |
| Patient Population | Adults | Adults | Adults |
| Prescription Use | RX only | RX only | RX only |
| Environment | Dental prosthetics and<br>authorized laboratories and<br>clinics.<br>Orthocem must be stored in<br>temperatures between 5° to<br>30°C.<br>Ortho Bite must be stored in<br>temperatures between 5° to<br>27°C. | Dental prosthetics and authorized<br>laboratories and clinics.<br>Transbond™ XT must be stored in<br>temperatures between 2° to 27°C. | Dental prosthetics and<br>authorized laboratories and<br>clinics.<br>Ultra Band-Lok must be stored<br>at room temperature (15-<br>30°C). |
| Applicable Standards | ISO 4049; ISO 29022; ISO<br>10993 | Not Available, details not disclosed<br>by manufacturer. | Not Available, details not<br>disclosed by manufacturer. |
| Base Composition | The adhesives contain<br>methacrylate as resin fillers and<br>silica that is used as fillers. | The adhesive contains<br>methacrylate as resin fillers and<br>silica that is used as fillers. | The adhesive contains<br>methacrylate as resin fillers<br>and silica that is used as<br>fillers. |
| Device Sterilization | Not Applicable | Not Applicable | Not Applicable |
| Primary Package<br>Container: | Capsule, Syringe | Capsule, Syringe | Syringe |
| Shelf life | Orthocem: 2 years<br>Ortho Bite: 3 years | Not Available, details not disclosed<br>by manufacturer. | Not Available, details not<br>disclosed by manufacturer. |
| Use the same<br>materials or<br>substances in contact<br>with the same human<br>tissues<br>or body fluids? | YES | YES | YES |
| Is the product in<br>compliance to EN ISO<br>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

K192682

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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

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K192682

| Reusable | NO | NO | NO |
|---------------------------------------------------------------------------|-------------|-------------|-------------|
| Duration | Permanent | Permanent | Permanent |
| Part of body | Oral, tooth | Oral, tooth | Oral, tooth |
| Is it used for the<br>same clinical<br>condition? | YES | YES | YES |
| Is it used at the same<br>site in the body? | YES | YES | YES |
| Is it used in a similar<br>population? | YES | YES | YES |
| Is it used for the<br>same intended<br>purpose? | YES | YES | YES |
| Is not foreseen to<br>deliver significantly<br>different<br>performances? | NO | NO | NO |
| Is it similar conditions<br>of use? | YES | YES | YES |
| Is it similar<br>specifications and<br>properties | YES | YES | YES |
| Is it similar principles<br>of operation? | YES | YES | YES |

| | Orthocem | Ortho Bite | Transbond XT | Ultra Band-Lok |
|---------------------------------|---------------------------|---------------------------|------------------------|---------------------------------------|
| Sensitivity to ambient<br>light | Physically<br>homogeneous | Physically<br>homogeneous | Physically homogeneous | Not disclosed by the<br>manufacturer1 |
| Depth of cure | 2.830 mm | 2.993 mm | 2.993 mm | Not disclosed by the<br>manufacturer1 |
| Flexural strength | 82.01 MPa | 118.30 MPa | 142.30 MPa | Not disclosed by the<br>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'.

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| Water sorption and solubility | Sorption: 31.43 µg/mm³<br>Solubility: 5.66 µg/mm³ | Sorption: 30.16 µg/mm³<br>Solubility: 5.76 µg/mm³ | Sorption: 25.13 µg/mm³<br>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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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.

K192682

# 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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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<br>environment<br>lighting - ISO<br>4049 | According to the ISO 4049 standard,<br>acceptance is related to the physical<br>homogeneity of the sample, so the material<br>was compared after the test to the same<br>material pressed between coverslips, but<br>without exposure to ambient light. Thus,<br>there is no difference between the samples. | All results are within the range specified by ISO<br>4049. |
| Depth of Cure<br>- ISO 4049 | According to ISO 4049, the specification for<br>this material is that its curing depth is: ><br>1.0 mm for opaque materials and > 1.5 mm<br>for non-opaque materials. | All results are greater than the specified<br>threshold, therefore the material is considered to<br>be in conformity. |
| Flexural<br>strength | According to the EN ISO 4049 standard the<br>specification for flexural strength is<br>≥50MPa. | All results are greater than the specified<br>threshold, therefore the material is considered to<br>be in conformity |
| Water<br>sorption and<br>solubility | Sorption: Maximum of 40 µg/mm³.<br>Solubility: maximum of 7.5 µg/mm³. | The results demonstrate that the product<br>complies the specification in the EN ISO 4049<br>Standard. |
| Accelerated<br>Stability<br>Studies | Study created to accelerate the possible<br>chemical degradation and/or physical<br>changes of the product in forced conditions<br>of storage. | Considering the results observed at the end of<br>the 183 days test period, the shelf-life of 2 years<br>in the storage condition of 30°C for the product<br>can be confirmed. |
| Evaluation<br>Report of<br>Long-Term<br>Stability<br>(Shelf) | Study designed to verify the physical and<br>chemical characteristics of the product<br>during the expected shelf life. The results<br>are used to confirm the expiration date and<br>storage conditions. | Considering the results observed at the end of<br>the 24 months of the long-term test (shelf), the<br>shelf life of 2 years in the storage condition of<br>30°C for the product can be confirmed. |
| Transport<br>evaluation<br>report | We performed a testing according to ASTM<br>D4169 | The testing results were successful and we had<br>only aesthetic damages considered irrelevant.<br>However, initially the test report advised that the<br>packages did not meet the minimum criteria for<br>compression testing. Therefore, a new testing<br>was performed aiming to re-evaluate the<br>paperboard compression resistance. DENTSCARE<br>modified the paperboard specs and submitted to<br>CETEA to repeat the assessment. According to<br>TEST REPORT CETEA RE 07.217/17, all evaluated<br>samples met the compression criteria required by<br>ASTM D4169 standard. |
| Shear Bond<br>Strength -<br>ISO 29022 | According to ISO 29022 standard, the test<br>verifies the adhesive bond strength between<br>direct dental restorative materials and tooth<br>structure. The results are used to confirm<br>the adhesion of the product to the teeth | Orthocem: 14.70 MPa<br>Ortho Bite: 14.76 MPa<br>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

K192682

### ORTHO BITE

| Test | Specification | Results |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity to<br>environment<br>lighting - ISO<br>4049 | According to the ISO 4049 standard,<br>acceptance is related to the physical<br>homogeneity of the sample, so the material<br>was compared after the test to the same<br>material pressed between coverslips, but<br>without exposure to ambient light. Thus,<br>there is no difference between the samples. | All results are within the range specified by<br>ISO 4049. |
| Depth of Cure<br>- ISO 4049 | According to ISO 4049, the specification for<br>this material is that its curing depth is: ><br>1.0 mm for opaque materials and > 1.5 mm<br>for non-opaque materials. | All results are greater than the specified<br>threshold, therefore the material is considered<br>to be in conformity. |
| Flexural<br>strength | According to the EN ISO 4049 standard the<br>specification for flexural strength is<br>≥50MPa. | All results are greater than the specified<br>threshold, therefore the material is considered<br>to be in conformity. |
| Water<br>sorption and<br>solubility. | Sorption: Maximum of 40 µg/mm3.<br>Solubility: maximum of 7.5 µg/mm3. | The results demonstrate that the product<br>complies the specification in the EN ISO 4049<br>Standard. |
| Accelerated<br>Stability<br>Studies | Study created to accelerate the possible<br>chemical degradation and/or physical<br>changes of the product in forced conditions<br>of storage. | Considering the results observed at the end of<br>the 227 days test period, the shelf-life of 3<br>years in the storage condition of 27°C for the<br>product can be confirmed. |
| Evaluation<br>Report of<br>Long-Term<br>Stability<br>(Shelf) | Study designed to verify the physical and<br>chemical characteristics of the product<br>during the expected shelf life. The results<br>are used to confirm the expiration date and<br>storage conditions. | Considering the results observed at the end of<br>the 36 months of the long-term test (shelf),<br>the shelf life of 3 years in the storage<br>condition of 30°C for the product can be<br>confirmed. |
| Transport<br>evaluation<br>report | We performed a testing according to ASTM<br>D4169 | The testing results were successful and we<br>had only aesthetic damages considered<br>irrelevant. However, initially the test report<br>advised that the packages did not meet the<br>minimum criteria for compression testing.<br>Therefore, a new testing was performed<br>aiming to re-evaluate the paperboard<br>compression resistance. DENTSCARE modified<br>the paperboard specs and submitted to CETEA<br>to repeat the assessment. According to TEST<br>REPORT CETEA RE 07.217/17, all evaluated<br>samples met the compression criteria required<br>by ASTM D4169 standard. |
| Shear Bond<br>Strength -<br>ISO 29022 | According to ISO 29022 standard, the test<br>verifies the adhesive bond strength between<br>direct dental restorative materials and tooth<br>structure. The results are used to confirm<br>the adhesion of the product to the teeth<br>surface. | Orthocem: 14.70 MPa<br>Ortho Bite: 14.76 MPa<br>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.