(183 days)
Opallis (Sculptable version)
- The composite is suitable for use in permanent and deciduous teeth:
- Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI.
- Direct veneers with composites.
- Cementation of tooth fragments.
- Core build-ups.
- Teeth splinting.
- Diastema closing or reduction.
- Modification of teeth's shape (e.g .: conoid teeth).
- Porcelain/composite repairs.
Opallis Flow (Flowable version)
- Base/lining underneath direct restorations.
- Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy
- Pit and fissure sealant.
- Tunnel-type preparation.
- Repair of enamel defects.
- Bonding of tooth fragments.
- Repairs in composite resin.
- Non-carious cervical lesions.
- Planning of preparation walls.
Opallis is a, radiopaque, light-curing composite resin with fluorescent and opalescent properties. It is an aesthetic restorative material used for restorations of anterior and posterior teeth.
Opallis Flow is a light-curing composite resin used for the restoration of slightly invasive preparations, pit and fissure sealant, base/lining underneath direct restorations, in tunnel-type preparations, radiopaque lining of cavities, repairs of enamel defects, restorations of primary teeth, repairs in composite resin, bonding of tooth fragments, class I, III and V restorations, non-carious cervical lesions. Opallis Flow can be used separately or with Opallis composites.
The provided text describes the acceptance criteria and performance data for two dental composite resins, Opallis and Opallis Flow, to demonstrate their substantial equivalence to predicate devices for FDA 510(k) clearance.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance (Opallis and Opallis Flow):
| Test | Acceptance Criteria (Specification) | Opallis Reported Performance | Opallis Flow Reported Performance |
|---|---|---|---|
| Sensitivity to ambient lighting | Physical homogeneity of the sample after exposure to ambient light (compared to unexposed material). Must show no difference. (ISO 4049) | All results are within the range specified by ISO 4049 (material considered physically homogeneous). | All results are within the range specified by ISO 4049 (material considered physically homogeneous). |
| Depth of Cure | > 1.0 mm for opaque materials; > 1.5 mm for non-opaque materials. (ISO 4049) | Opaque shades: 2.99 mmNon-opaque shades: 2.84 mm All results > specified threshold. | Opaque shades: 2.97 mmNon-opaque shades: 3.01 mm All results > specified threshold. |
| Color tone stability | No more than a small change in color, as determined by visual inspection by three observers with normal vision in a D65 light chamber, comparing specimen on a diffuse white background against a gray background. (ISO 4049 and ISO 7491) | All comparisons carried out by three observers with normal eyesight; no color difference attested. | All comparisons carried out by three observers with normal eyesight; no color difference attested. |
| Radiopacity | Values found in specimens demonstrating they are radiolucent, typically between the second and third scale of the aluminum part. (ISO 4049) | 2.46 mm. Values found are between the second and third scale of the aluminum part. | 2.49 mm. Values found are between the second and third scale of the aluminum part. |
| Flexural Strength | ≥ 80 MPa (EN ISO 4049) | 93.38 MPa. All results > specified threshold. | 137.80 MPa. All results > specified threshold. |
| Water Sorption | Maximum of 40 µg/mm³ (ISO 4049) | 28.93 µg/mm³. Complies with specification. | 27.92 µg/mm³. Complies with specification. |
| Solubility | Maximum of 7.5 µg/mm³ (ISO 4049) | 5.53 µg/mm³. Complies with specification. | 5.46 µg/mm³. Complies with specification. |
| Shelf Life (Accelerated Stability) | Confirmed shelf-life based on accelerated degradation studies (e.g., 3 years at 30°C). | 3 years at 30°C confirmed based on 274 days test. | 3 years at 30°C confirmed based on 274 days test. |
| Shelf Life (Long-Term Stability) | Confirmed shelf-life based on physical and chemical characteristics during expected shelf life (e.g., 3 years at 30°C). | 3 years at 30°C confirmed based on 36 months test. | 3 years at 30°C confirmed based on 36 months test. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not explicitly state the specific numerical sample size (e.g., number of specimens tested for each physical property). It refers to "the samples" for various tests.
- Data Provenance: The tests are non-clinical and performed by the manufacturer, Dentscare LTDA, which is based in Joinville, Santa Catarina, Brazil. The studies appear to be prospective, laboratory-based tests comparing the manufactured devices against ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Color tone stability test: "three observers with normal eyesight, certified by a competent physician" were used for visual inspection. No further qualifications (e.g., years of experience, specific medical specialty) are provided beyond "normal vision" and "certified by a competent physician."
- For other physical property tests (e.g., flexural strength, depth of cure), the "ground truth" is established by adherence to International Standards (ISO 4049) rather than expert consensus on individual outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For Color tone stability, it states: "All comparisons were carried out by three observers... They did not attest to any color difference in the samples analyzed." This implies a form of consensus or 3/3 agreement among these observers. There is no explicit mention of an adjudication process like "2+1" if there were disagreement, but the stated outcome implies unanimous agreement.
- For other tests, adherence to the numerical specifications of ISO standards serves as the "adjudication."
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:
- No MRMC comparative effectiveness study was done. This device is a dental restorative material (composite resin), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental material, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For physical and chemical properties, the ground truth is based on International Standards specifications (specifically ISO 4049) and objective measurements compared against these predefined ranges.
- For biocompatibility, the ground truth is established through laboratory in-vitro and in-vivo tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation) conducted according to ISO 10993 standards. Additionally, the pre-existence of similar products on the market ("long term (10 years) the subject devices are in the market with no chronic toxicity reported") and comparison to predicates with more complex formulations (Vittra APS) informs the biocompatibility conclusions.
- For Color tone stability, a form of expert visual consensus (3 certified observers) is used against a control.
8. The sample size for the training set:
- Not applicable. This is a physical dental material. The "training" for such devices would be the manufacturing process development and quality control, not a data-driven training set in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI/algorithm where ground truth is established. The manufacturing and material specifications are developed and validated against industry standards and internal quality controls.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 22, 2020
Dentscare LTDA % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K201707
Trade/Device Name: Opallis, Opallis Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 16, 2020 Received: June 22, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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 Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201707
Device Name Opallis and Opallis Flow
Indications for Use (Describe)
Opallis (Sculptable version)
- The composite is suitable for use in permanent and deciduous teeth:
- Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI.
- Direct veneers with composites.
- Cementation of tooth fragments.
- Core build-ups.
- Teeth splinting.
- Diastema closing or reduction.
- Modification of teeth's shape (e.g .: conoid teeth).
- Porcelain/composite repairs.
Opallis Flow (Flowable version)
- Base/lining underneath direct restorations.
- Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy
- Pit and fissure sealant.
- Tunnel-type preparation.
- Repair of enamel defects.
- Bonding of tooth fragments.
- Repairs in composite resin.
- Non-carious cervical lesions.
- Planning of preparation walls.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with horizontal lines inside it, and the text "DentsCare" 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.
510(k) SUMMARY
December 10, 2020
- A) Submitter's Name: DENTSCARE LTDA
Owner / Operator Registration Number: 3007210751
Manufacture Registration Number: 3007210751
- B) Address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL
- C) Phone and Fax Numbers
Phone: +55 (47) 34416131
- D) Contact Person:
Roberta Uyara
Tel.: +55 (47) 34416131
- E) Latest Revision Date: December 10, 2020
- F) Classification Name: Tooth shade resin material.
Common / Usual Name: Tooth shade resin material.
Proprietary Name: Opallis and Opallis Flow
Product Code: EBF
Class: Class II
Regulation: 21 CFR 872.3690
G) Device Description
Opallis
Opallis is a, radiopaque, light-curing composite resin with fluorescent and opalescent properties.
It is an aesthetic restorative material used for restorations of anterior and posterior teeth.
Opallis Flow
Opallis Flow is a light-curing composite resin used for the restoration of slightly invasive preparations, pit and fissure sealant, base/lining underneath direct restorations, in tunnel-type preparations, radiopaque lining of cavities, repairs of enamel defects, restorations of primary teeth, repairs in composite resin, bonding of tooth fragments, class I, III and V restorations, non-carious cervical lesions. Opallis Flow can be used separately or with Opallis composites.
H) Substantial Equivalence:
The Opallis and Opallis Flow are equivalent with the following products:
| Equivalence | 510(k)Number | Model | Company |
|---|---|---|---|
| Primary Predicate | K042819 | TETRIC EVOCERAM | IVOCLAR VIVADENT AG |
| Secondary Predicate | K993783 | TETRIC EVOFLOW | IVOCLAR VIVADENT AG |
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Image /page/4/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter 'D' in a gray color, with three horizontal lines inside the 'D' to represent airflow. Below the symbol is the text 'DentsCare' in a sans-serif font, also in gray.
NTSCARE LTDA AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA ARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| Reference Predicate | K191306 | Llis, Vittra APS | DENTSCARE LTDA |
|---|---|---|---|
| Reference Predicate | K192682 | Orthocem, Ortho Bite | DENTSCARE LTDA |
The primary and secondary predicates support substantial equivalence to the subject device, for technological characteristics, indications for use, and performance.
The reference devices support substantial equivalence for the composition comparison in the biocompatibility assessment.
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Image /page/5/Picture/0 description: The image shows the logo and contact information for Dentscare LTDA. The logo features a stylized letter D with wave-like lines inside it, accompanied by the text "DentsCare" in a distinct font. The contact information includes the company's address on AV. EDGAR NELSON MEISTER, 474, in JOINVILLE, SANTA CATARINA, BRAZIL, with the postal code 89219-501, and the phone number 55 - 47 - 3441-6131.
I) Indications for Use:
| Indications for Use Comparison | ||
|---|---|---|
| Opallis and Opallis Flow | Tetric Evoceram (K042819) | Tetric Evoflow (K993783) |
| OpallisThe composite is suitable for use inpermanent and deciduous teeth:- Direct restorations in anterior andposterior teeth Classes I, II, III, IV, Vand VI.- Direct veneers with composites.- Cementation of tooth fragments.- Core build-ups.- Teeth splinting.- Diastema closing or reduction.- Modification of teeth's shape (e.g.:conoid teeth).- Porcelain/composite repairs. | - Anterior restorations (Class III, IV)- Class V restorations (cervical caries,root erosion, wedge-shaped defects)- Restorations in the posterior region(Class I and II)- Veneering of discolored anterior teeth- Splinting of mobile teeth- Repair of composite and ceramicveneers | - Class V restorations (cervical caries, rooterosion, wedge-shaped defects)- Anterior restorations (Classes III, IV)- Small posterior restorations- Restorative therapy for mini-cavities of alltypes- Adhesive cementation of Sonic-Sys Inlays- Extended fissures sealings in molars andpre-molars- Repair of composite/ceramic veneers- Blocking out of undercuts- Adhesive cementation of ceramic andcomposite restorations |
| Opallis Flow- Base/lining underneath directrestorations.- Small, non-occlusal stress-bearing classI restorations according to minimallyinvasive filling therapy- Pit and fissure sealant.- Tunnel-type preparation.- Repair of enamel defects.- Bonding of tooth fragments.- Repairs in composite resin.- Non-carious cervical lesions.- Planning of preparation walls. |
Discussion:
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Image /page/6/Picture/0 description: The image shows the logo and contact information for DentsCare LTDA. The logo features a stylized letter D with horizontal lines inside, accompanied by the text "DentsCare" in a smaller font. 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".
Opallis X Tetric Evoceram
Opallis and Tetric Evoceram are composite resins indicated for direct restorative procedures on deciduous and permanent teeth. The range of clinical situations in which direct composites can be indicated is very wide. In additional indications for restoring cavities, direct veneers with composites, core build-ups, diastema closing or reduction, modification of teeth 's shape (e.q.; conoid teeth), repair of small defects of the enamel, repair of porcelain or composite and build-ups for transparent, removable Invisalign® orthodontic retainers are examples of direct restoration (according to the Indications for use available in the manufacturer's website). As well as the use of dental splinting technique in cases of trauma and periodontal diseases. As a conclusion, the subject and the same indication for use.
Opallis Flow X Tetric Evoflow
Low viscosity light cured materials such as Opallis Flow and Tetric Evollow are suitable for various indications such as: Base /lining, restorations made under other restorative material likewise an initial layer in all type of cavity. This main indication has as examples: Tunnel-type, planning of preparation walls.
Small restorations of all types and Small, non-occlusal strestorations according to minimally invasive filling therapy: restorations made in receive direct masticatory load. These following indications are related to this definition: Pit and fissure sealant. Repair of enaments. Repair in composite resin. Non-carious cervical lesions, Class V restorations (cervical caries, root erosion, wedge-shaped defects), blocking out of undercuts. Even though there are minor differences between the indications for use of products Opallis Flow and Tetric Evoflow (since the Tetric Evollow, according to the Indications for use available in the manufacturer's website, is indicated for Splinting of mobile teeth and adhesive cementation of light-transmissive ind ceramic restorations) it can be concluded that both product have the same applicability.
Opallis is a condensable composite resin and Opallis Flow is its fluid counterpart for anterior restoration, such as Tetric Evoceram and Tetric Evoflow.
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J) Technological Characteristics Comparison:
The predicate and reference devices used to establish substantial equivalence for the Opallis Flow devices are outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Opallis and Opallis Flow to each of the predicate devices stratified by functional modality. Page 5-3
| Device Manufacturer andCommon Name | OPALLIS, OPALLIS FLOWDENTSCARE | TETRIC EVOCERAMIVOCLAR VIVADENT AG(Predicate) | TETRIC EVOFLOWIVOCLAR VIVADENT AG(Reference) |
|---|---|---|---|
| 510k # | Not assigned yet | K042819 | K993783 |
| Classification | Class II | Class II | Class II |
| Regulation # | 21 CFR 872.3690 | 21 CFR 872.3690 | 21 CFR 872.3690 |
| Product Code | EBF | EBF | EBF |
| Classification Name | Tooth shade resin material. | Tooth shade resin material. | Tooth shade resin material. |
| Patient Population | All the groups | All the groups | All the groups |
| Prescription Use | RX only | RX only | RX only |
| Environment | Dental prosthetics and authorizedlaboratories and clinics.Opallis/Opallis Flow must be storedin temperatures between 5 - 30°C. | Dental prosthetics and authorizedlaboratories and clinics.Tetric EvoCeram must be storedin temperatures between 2-28°C. | Dental prosthetics and authorizedlaboratories and clinics.Tetric EvoFlow must be stored intemperatures between 2-28°C. |
| Applicable Standards | ISO 4049 ; ISO 10993 | ISO 4049; ISO 10993 | ISO 4049; ISO 10993 |
| Device Sterilization | Not Applicable | Not Applicable | Not Applicable |
| Primary Package Container: | Syringe and capsule | Syringe and capsule (cavifil) | Syringe and capsule (cavifil) |
| Shelf life | 3 years | Information not disclosed by themanufacturer. | Information not disclosed by themanufacturer. |
| Use the same materials orsubstances in contact withthe same human tissuesor body fluids? | YES | YES | YES |
| Is the product in complianceto EN ISO 10993? | YES | YES | YES |
| Tissues | Enamel and Dentin | Enamel and Dentin | Enamel and Dentin |
| Reusable | NO | NO | NO |
| Duration | Permanent | Permanent | Permanent |
| Part of body | Oral, teeth | Oral, teeth | Oral, teeth |
| Is it used for the sameclinical condition? | yes | yes | yes |
| Is it used at the same site inthe body? | yes | yes | yes |
| Is it used in a similarpopulation? | yes | yes | yes |
| Is it used for the sameintended purpose? | yes | yes | yes |
| Is not foreseen to deliversignificantly differentperformances? | no | no | no |
| Is it similar conditions ofuse? | yes | yes | yes |
| Is it similar specifications andproperties | yes | yes | yes |
| Is it similar principles ofoperation? | yes | yes | yes |
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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, followed by the text 'DentsCare'. Below the logo is the company's address: AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL, and their phone number: Ph: 55 - 47 - 3441-6131.
| CLINICAL STEP | Opallis, Opallis FlowDentsCare | Tetric EvoceramIvoclar Vivadent AG | Tetric EvoflowIvoclar Vivadent AG |
|---|---|---|---|
| Two options: total damisolation or relative isolation | YES | YES | YES |
| Application according toadhesive technique | YES | YES | YES |
| Size for increments | 1,5-2mm | 1,5-2mm | 1,5-2mm |
| Light curing unit | POWER ≥ 450mW/cm2 andWAVELENGTH OF 400-500nm | POWER ≥ 500mW/cm2 andWAVELENGTH OF 400-500nm | POWER ≥ 500mW/cm2 andWAVELENGTH OF 400-500nm |
| Require finishing andpolishing | YES | YES | YES |
| Specification | OpallisDentsCare | Opallis FlowDentsCare | Tetric Evoceram1Ivoclar | Tetric Evoflow1Ivoclar |
|---|---|---|---|---|
| --------------- | ---------------------- | --------------------------- | ----------------------------- | ---------------------------- |
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Image /page/9/Picture/0 description: The image contains the logo for DentsCare. The logo features a stylized letter D with three horizontal lines inside the curve of the D, followed by the text "DentsCare" in a sans-serif font. To the right of the logo, there is text that reads "DENTSCARE AV. EDG" followed by "Ph: 55-".
| Flexural strength | 93.38 MPa | 137.80 MPa | 120 MPa | 114 MPa |
|---|---|---|---|---|
| Depth of cure | Opaque shades: 2.99 mmNon-opaque shades: 2.84 mm | Opaque shades: 2.97 mmNon-opaque shades:3.01 mm | > 1.5 mm | > 2.0 mm |
| Color stability | The observers did notattest any difference ofcolor | The observers did notattest any difference ofcolor | Not disclosed by themanufacturer | Not disclosed by themanufacturer |
| Sensitivity to ambientlight | Physically homogeneous | Physically homogeneous | Not disclosed by themanufacturer | Not disclosed by themanufacturer |
| Water sorption | 28.93 µg/mm³ | 27.92 µg/mm³ | 21.2 µg/mm³ | 21.0 µg/mm³ |
| Solubility | 5.53 µg/mm³ | 5.46 µg/mm³ | < 1.0 µg/mm³ | 0.1 µg/mm³ |
| Radiopacity | 2.46 mm | 2.49 mm | Not disclosed by themanufacturer | Not disclosed by themanufacturer |
1According to Scientific Documentation disclosed by the manufacturer on https://www.ivoclarvivadent.com/zooluwebsite/media/document/928/Tetric+EvoCeram+-+Tetric+EvoFlow
Discussion:
The subject devices are similar to the pre all light-curing, radiopaque composites for restorations. The subject device, Opallis and the predicate device, Tetric EvoCeram are sculptable composites and both offer the flowable version, Opallis Flow and Tetric EvoFlow, Flowable composites are indicated for initial layer in large Class I and II, since they are more well adaptable to the cavities.
The subject devices and the predicate devices are substantially equivalent when comparing indications for use, shelf life, physical and technological properties. Considering physical properties and performance of the products meet the International Standard ISO 4049 requirements, they are substantial equivalent.
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Image /page/10/Picture/0 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 wavy lines, also in the same color, suggesting movement or flow. Below the symbol, the word "DentsCare" is written in a simple, sans-serif font, with the first letter capitalized and the rest in lowercase.
ELSON MEISTER. 474. JOINVILLE, NA 89219-501 BRAZIL
K) Applicable Standards:
In order to reach substantially equivalent to the predicate device the subject device Opallis and Opallis Flow were 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)
This 510(k) submission addresses the recommendation described on the Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions
Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device Opallis and Opallis Flow demonstrate equivalency to the predicate device.
L) Risk Management:
In order to identified and mitigate the risks to health associated with the use of dental composite resin we have developed the risk analysis management file which includes the risk analysis method and results.
M) Non-clinical Testing:
In order to study the performance of the product, pre-clinical tests were performed according to the summary table below.
Opallis
| 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 - | According to ISO 4049, the | All results are greater than the |
| ISO 4049 | specification for this material isthat its curing depth is: > 1.0 mmfor opaque materials and > 1.5mm for non-opaque materials. | specified threshold, thereforethe material is considered to bein conformity. |
| The acceptance must beperformed provided that there isno more than a small change incolor, it must be proven as follows: | ||
| Color tonestability afterradiation andwater absorption-ISO 4049 andISO 7491 | a) comparisons should bemade by visual inspection andanalyzed by three observers withnormal vision, who do not identifyany differences in color, thiscomparison must be carried at adistance of 200 to 300 mm for aperiod of no more than 2 seconds;b) perform the comparisoncited in a) in a light chamber atDay Light - D65 mode.c) perform the comparison inparagraph a), by placing thespecimen on a diffuse whitebackground of 90% approximatereflectance, and it should have asa limiting size the size of thespecimen, which must besurrounded by a grey backgroundwith a diffuse reflectance of 30 ±5%. | All comparisons were carriedout by three observers withnormal eyesight, certified by acompetent physician. They didnot attest to any color differencein the samples analyzed.The results demonstrate that theproduct meets ISO 4049. |
| Radiopacity-ISO 4049 | Compare the individual opticaldrives of each aluminum scaleagainst the density of each scale(this check must be performedusing ISO 4049 as reference). Getthe value of the opticaldensity/grey value for the δsthickness of the specimen anddetermine the correspondingvalue of aluminum, δa. | The values found in thespecimens are between thesecond and third scale of thealuminum part, proving that thematerial is radiolucent accordingto the requirements of ISO 4049 |
| FlexingResistance-ISO 4049 | According to the EN ISO 4049standard the specification forflexural strength is ≥80MPa. | All results are greater than thespecified threshold, thereforethe material is considered asconformant. |
| Water sorptionand solubility.- ISO 4049 | Sorption: Maximum of 40 µm/mm3.Solubility: maximum of 7.5µm/mm3. | The results demonstrate that theproduct complies thespecification in the EN ISO 4049Standard. |
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Image /page/11/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a muted blue-gray color. Inside the "D", there are three horizontal lines that appear to represent airflow or movement. 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 SANTA CATARINA CATARINA 89219-1
DentsCare Ph: 55 - 47 - 3441-6131
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Image /page/12/Picture/0 description: The image shows a logo with a stylized letter 'D' at the top and the word 'DentsCare' below it. The 'D' is gray and has three horizontal lines inside, suggesting movement or airflow. The word 'DentsCare' is in a smaller font and appears to be part of the company's name or branding.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare ph: 55 - 47 - 3441-6131
| AcceleratedStability Studies | Study created to accelerate thepossible chemical degradationand/or physical changes of theproduct in forced conditions ofstorage. | Considering the resultsobserved at the end of the 274days test period, the shelf-life of3 years in the storage conditionof 30 °C for the product can beconfirmed. |
|---|---|---|
| EvaluationReport of Long-Term Stability(Shelf) | Study designed to verify thephysical and chemicalcharacteristics of the productduring the expected shelf life. Theresults are used to confirm theexpiration date and storageconditions. | Considering the resultsobserved at the end of the 36months of the long-term test(shelf), the shelf life of 3 years inthe storage condition of 30°C forthe product can be confirmed. |
| AcceleratedStability Studies- Capsule | Study created to accelerate thepossible chemical degradationand/or physical changes of theproduct in forced conditions ofstorage. | Considering the resultsobserved at the end of the 274days test period, the shelf-life of3 years in the storage conditionof 30 °C for the product can beconfirmed. |
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Image /page/13/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color. Inside the "D", there are three horizontal lines that resemble waves or airflow. Below the "D", the word "DentsCare" is written in a sans-serif font, also in gray.
DENTSCARE LTDA
AV. EDGAR NELSON MEISTER, 474, JOINVILLE,
SANTA CATARINA 89219-501 BRAZIL DentsCare ph: 55 - 47 - 3441-6131
Opallis Flow
| 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. | |
| Color tone stability after radiation and water absorption ISO 4049 and ISO 7491 | The acceptance must be performed provided that there is no more than a small change in color, it must be proven as follows:a) comparisons should be made by visual inspection and analyzed by three observers with normal vision, who do not identify any differences in color, this comparison must be carried at a distance of 200 to 300 mm for a period of no more than 2 seconds;b) perform the comparison cited in a) in a light chamber at Day Light - D65 mode.c) perform the comparison in paragraph a), by placing the specimen on a diffuse white background of 90% approximate reflectance, and it should have as a limiting size the size of the specimen, which must be surrounded by a grey background with a diffuse reflectance of 30 ± 5%. | All comparisons were carried out by three observers with normal eyesight, certified by a competent physician. They did not attest to any color difference in the samples analyzed.The results demonstrate that the product meets ISO 4049. | |
| Radiopacity - ISO 4049 | Compare the individual optical drives of each aluminum scale against the density of each scale (this check must be performed using ISO 4049 as reference). Get the value of the optical | The values found in the specimens are between the second and third scale of the aluminum part, proving that the material is radiolucent according | |
| density/grey value for the δsthickness of the specimen anddetermine the correspondingvalue of aluminum, δα. | to the requirements of ISO 4049 | ||
| FlexingResistanceISO 4049 | According to the EN ISO 4049standard the specification forflexural strength is ≥80MPa. | All results are greater than thespecified threshold, thereforethe material is considered asconformant. | |
| Water sorptionand solubility.ISO 4049 | Sorption: Maximum of 40 µm/mm³.Solubility: maximum of 7.5µm/mm³. | The results demonstrate that theproduct complies thespecification in the EN ISO 4049Standard. | |
| AcceleratedStability Studies | Study created to accelerate thepossible chemical degradationand/or physical changes of theproduct in forced conditions ofstorage. | Considering the resultsobserved at the end of the 274days test period, the shelf-life of3 years in the storage conditionof 30 °C for the product can beconfirmed. | |
| EvaluationReport of Long-Term Stability(Shelf) | Study designed to verify thephysical and chemicalcharacteristics of the productduring the expected shelf life. Theresults are used to confirm theexpiration date and storageconditions. | Considering the resultsobserved at the end of the 36months of the long-term test(shelf), the shelf life of 3 years inthe storage condition of 30°C forthe product can be confirmed. |
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Image /page/14/Picture/0 description: The image shows a logo for a company called "DentsCare". The logo features a stylized letter "D" in a gray color. Inside the "D", there are three horizontal lines that resemble waves. The text "DentsCare" is written below the "D" in a smaller font size, also in gray.
dentscare Ltda AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
Conclusion: Based on the performance test applied to this Opallis and Opallis Flow and the predicate comparison, we conclude that the subject device is substantially equivalent with the predicate.
| Biological endpoint | Test article | Rationale for why additional information isn't needed |
|---|---|---|
| Cytotoxicity | Orthocem UVTrace, Opallis,Vittra APS | The citotoxicity test was performed with the pool samplesOrthocem UV Trace, Opallis and Vittra APS and theyshowed no toxic effect on the cell line V-79, so Opallis andOpallis Flow are not considered cytotoxic. |
| Sensitization | Orthocem UVTrace, Opallis,Vittra APS | The sensitization test was performed with the pool samplesOrthocem UV Trace, Opallis and Vittra APS. Considering thetest result, Opallis and Opallis Flow can be considered asnon-sensitizing. |
| Irritation orIntracutaneousreactivity | Orthocem UVTrace, Opallis,Vittra APS | The test for irritation was performed with the pool samplesOrthocem UV Trace, Opallis and Vittra APS and noalterations were observed in the oral mucosa exposed tothe pool as well as in the cheek pouches of the control |
| animals, so Opallis and Opallis Flow can be considered asnon-irritating oral mucosa. | ||
| Acute SystemicToxicity | Vittra APS | According to ISO 10993-1:2018, item 6.3.2.6, acutesystemic toxicity tests can be combined with subacute andsubchronic toxicity and implantation test protocols. |
| Material-MediatedPyrogenicity | Not applicable | According to ISO 10993-1:2018, item 6.3.2.5, material-mediated pyrogenicity is rare. It has been observed inmedical devices containing biologically derived material.Taking into account the chemical and physical nature of thesubject devices, the existing information based on theliterature regarding the chemical ingredients in theformulation and the previous experience with products withsimilar formulation, the test for material-mediatedpyrogenicity is not applicable. |
| Subacute/Subchronictoxicity | Vittra APS | According to ISO 10993-1:2018, item 6.3.2.7, subacuteand subchronic systemic toxicity test protocols can beexpanded to include implantation test protocols to evaluatesubacute and subchronic systemic and local effects. |
| Genotoxicity | Orthocem UVTrace, Opallis,Vittra APS | The test for genotoxicity was performed with the poolsamples Orthocem UV Trace, Opallis and Vittra APS and theproducts did not induce gene mutations. Considering thetest result, Opallis and Opallis Flow are not genotoxicity. |
| Orthocem UVTrace, Opallis,Vittra APS | The study for genotoxicity was performed with the poolsamples Orthocem UV Trace, Opallis and Vittra APS and itdid not show a genotoxic effect. Considering the test result,Opallis and Opallis Flow are not genotoxicity. | |
| Implantation | Vittra APS | The test for implantation was performed with the productVittra APS, that is a Dentscare product previously reviewedby FDA, with more complex formulation when compared toOpallis and Opallis Flow. According to the comparative tablein item 5.1, all the ingredients present in the subjectdevices were tested, except Bis-GMA, Bis-EMA, DDDMA andC431810 Ultra Blue, however, these ingredients are widelyused in the industry and they are in the formulation ofdevices previously reviewed by FDA. Considering thesepoints and the test result, Opallis and Opallis Flow can beconsidered non-toxic and non-irritant. |
| Chronic Toxicity | Not applicable | Taking into account the long term (10 years) the subjectdevices are in the market with no chronic toxicity reported,the test is not needed to ensure the safety. |
| Carcinogenicity | Not applicable | Considering literature reviews and wide knowledgeregarding the chemical ingredients in the formulation and |
N) SUMMARY BIOCOMPATIBILITY DOCUMENTATION
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Image /page/15/Picture/0 description: The image shows the logo for DentsCare. The logo features a stylized letter "D" in a gray color, with three horizontal lines inside the "D" to represent airflow. 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 DentsCare ph: 55 - 47 - 3441-6131
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Image /page/16/Picture/0 description: The image contains the logo for DentsCare. The logo features a stylized letter 'D' in a gray color, with three horizontal lines inside the 'D' to represent teeth. Below the logo, the word 'DentsCare' is written in a bold, sans-serif font, also in gray. The overall design is clean and modern, suggesting a professional and trustworthy dental care service.
dentscare Ltda AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL Ph: 55 - 47 - 3441-6131
| the previous experience with products with similar |
|---|
| formulation, the products are not carcinogenicity potential, |
| so the test for carcinogenicity is not applicable. |
CONCLUSION
In accordance to results of biocompatibility tests ISO 10993 carried out with Opallis, taking into account the results of test with Vittra APS (more complex chemical composition) and given the time the Opallis family of products has been on the market, we can assure that the Opallis Flow are biocompatible for using in human patients.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.