(121 days)
The SimpliShade Bulk Fill is indicated for:
- Direct placement of anterior and posterior restorations.
- Core build-ups.
- Repair of defects in restorations.
The SimpliShade Bulk Fill Flow is indicated for:
- Base/liner under Class I and Class II direct restorations.
- Pit and fissure sealant.
- Restoration of small cavities.
- Class III and V restorations.
- Blocking out undercuts.
- Small core build-ups.
- Repair of resin and acrylic provisional restorations.
SimpliShade™ Bulk Fill Composite is offered in two types of viscosities: the high viscosity formula will be branded as SimpliShade™ Bulk Fill; the low viscosity formula will be branded as SimpliShade™ Bulk Fill Flow.
SimpliShade Bulk Fill is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed for the placement of direct restorations. SimpliShade Bulk Fill is designed to be used after placement of a dental adhesive, such as a product from the Kerr OptiBond™ family. SimpliShade Bulk Fill is available in Unidose™ compules and syringe delivery systems that are suitable for occlusal surfaces. The product offers allows a technique in which a cavity up to 5 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill is offered in one universal shade to optically blend with a range of VITA™ shade guide equivalents. This composite can be polished with a wide variety of polishing discs, rubber cups, and brushes.
SimpliShade Bulk Fill Flow is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed to be used as a base or liner in Class I and II restorations and must be overlayed with a composite resin to replace the occlusal surfaces. It is also suitable to be used on nonocclusal-contact surfaces, such as pit and fissures, core build-ups and Class III and V restorations. SimpliShade Bulk Fill Flow is available in Unidose™ compules and syringe delivery systems. The product allows a technique in which a cavity up to 4 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill Flow is offered in one universal shade to optically blend with a range of VITAM shade guide equivalents. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.
The provided text is a 510(k) Summary for dental resin materials. It describes the acceptance criteria and study proving the device meets these criteria, but it focuses on non-clinical performance and does not include information about clinical studies with human participants or AI-assisted performance analysis. Therefore, I cannot generate information related to multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance, as these are not present in the document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to international standards and internal benchmarks. The reported device performance indicates that the subject devices (SimpliShade™ Bulk Fill and SimpliShade™ Bulk Fill Flow) met these criteria.
| Acceptance Critieria | Reported Device Performance |
|---|---|
| For both SimpliShade™ Bulk Fill & SimpliShade™ Bulk Fill Flow: | |
| Curing Intensity (mW/cm²) | ≥ 650 mW/cm² (Similar to Predicate Devices which were ≥ 550 mW/cm²) |
| Wavelength (nm) for curing | 400 - 520 nm (Similar to Predicate Devices which were 400 - 500 nm) |
| Curing Time (sec) | 20 sec (≥ 650 mW/cm²) (Similar to Predicate Devices which were ≥ 20 sec at ≥ 550 mW/cm²) |
| Compressive Strength (MPa) | Meet the criteria per internal standard (>260 Mpa) |
| Rockwell Hardness (RHN) | Meet the criteria per internal standard (>65 RHN) |
| Flexural Strength (Mpa) | Conform to ISO 4049 requirement |
| Radio-opacity (mm of AI) | Conform to ISO 4049 requirement |
| Water Sorption (µg/mm³) | Conform to ISO 4049 requirement |
| Water Solubility (µg/mm³) | Conform to ISO 4049 requirement |
| Sensitivity to ambient light | Conform to ISO 4049 requirement (Same as Predicate Devices) |
| Color Stability | Conform to ISO 4049 requirement (Same as Predicate Devices) |
| Biocompatibility (ISO standards) | Conform to ISO 10993-1, -3, -5, -6, -10, -11, -12, -23 and ISO 7405. (Similar to Predicate devices) |
| Dentistry - Polymer-based restorative materials (ISO standard) | Conform to ISO 4049:2019 (Similar to Predicate devices which were ISO 4049:2009) |
| Specific to SimpliShade™ Bulk Fill: | |
| Depth of Cure (mm) | Up to 5mm (Similar to Predicate Device) |
| Recommended for load-bearing occlusal surfaces | Yes (Same as Predicate Device) |
| Specific to SimpliShade™ Bulk Fill Flow: | |
| Depth of Cure (mm) | Up to 4mm (Similar to Predicate Device) |
| Recommended for load-bearing occlusal surfaces | No (Same as Predicate Device) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of specimens tested) for each non-clinical test. It states that "Performance bench tests according to ISO 4049...have been conducted" and "Additional tests...have been performed." The data provenance is non-clinical laboratory testing, conducted by the manufacturer, Kerr Corporation, to demonstrate substantial equivalence to legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical study involving material properties, not diagnostic interpretation by human experts.
4. Adjudication method for the test set
Not applicable. Ground truth for material properties is established through standardized testing procedures, not by human adjudication of observations.
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. This document describes the non-clinical performance of dental restorative materials. It does not involve AI, human readers, or clinical effectiveness studies in this context. The section "Clinical Performance Data" explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the subject devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe AI algorithm performance.
7. The type of ground truth used
The ground truth is established through physical and chemical property measurements according to established international standards (e.g., ISO 4049, ISO 10993 series) and internal company standards. This involves objective measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is a non-clinical evaluation of material properties, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, there is no ground truth established in that context.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
August 31, 2022
Kerr Corporation Haiyan Wei Senior Regulatory Affairs Specialist 1889 W Mission Blvd Pomona, California 91766
Re: K221255
Trade/Device Name: SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 5, 2022 Received: August 5, 2022
Dear Haiyan Wei:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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 E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K221255
Device Name
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
Indications for Use (Describe)
The SimpliShade Bulk Fill is indicated for:
- Direct placement of anterior and posterior restorations.
- Core build-ups.
- Repair of defects in restorations.
The SimpliShade Bulk Fill Flow is indicated for:
- Base/liner under Class I and Class II direct restorations.
- Pit and fissure sealant.
- Restoration of small cavities.
- Class III and V restorations.
- Blocking out undercuts.
- Small core build-ups.
- Repair of resin and acrylic provisional restorations.
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 word "Kerr" in a bold, blue font. The word is written in all lowercase letters, except for the "K", which is capitalized. There is a trademark symbol to the right of the second "r" in the word. The background of the image is white.
K221255 - 510(k) Summary
for
SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow
1. Submitter Information:
Kerr Corporation 1889 W Mission Blvd Pomona, CA 91766 USA
| Contact Person: | Haiyan Wei |
|---|---|
| Telephone Number: | (714) 516-7710 |
| Email: | haiyan.wei@kavokerr.com |
June 27, 2022 Date Prepared:
2. Device Name:
| Proprietary Name: | SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow |
|---|---|
| Manufacturer: | Kerr Corporation |
| Common Name: | Tooth Shade Resin Material Restorative |
| Classification Name: | Tooth Shade Resin Material |
| CFR Number: | 872.3690 |
| Device Class: | II |
| Product Code: | EBF |
3. Predicate Device (Primary):
| Proprietary Name: | Filtek™ One Bulk Fill Restorative (K163207) |
|---|---|
| Manufacturer: | 3M ESPE Dental Products |
| Common Name: | Tooth Shade Resin Material Restorative |
| Classification Name: | Tooth Shade Resin Material |
| CFR Number: | 872.3690 |
| Device Class: | II |
| Product Code: | EBF |
Predicate Device #2:
| Proprietary Name: | Filtek™ Bulk Fill Flowable Restorative (K120453) |
|---|---|
| Manufacturer: | 3M ESPE Dental Products |
| Common Name: | Tooth Shade Resin Material |
| Classification Name: | Tooth Shade Resin Material |
| CFR Number: | 872.3690 |
| Device Class: | II |
| Product Code: | EBF |
4. Device Description:
SimpliShade™ Bulk Fill Composite is offered in two types of viscosities: the high viscosity formula will be branded as SimpliShade™ Bulk Fill; the low viscosity formula will be branded as SimpliShade™ Bulk Fill Flow.
SimpliShade™ Bulk Fill:
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Image /page/4/Picture/0 description: The image shows the logo for Kerr, a dental equipment and supplies manufacturer. The logo is in blue and features the company name in a bold, sans-serif font. A trademark symbol is located to the right of the company name. The logo is simple and modern, and the blue color gives it a professional look.
SimpliShade Bulk Fill is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed for the placement of direct restorations. SimpliShade Bulk Fill is designed to be used after placement of a dental adhesive, such as a product from the Kerr OptiBond™ family.
SimpliShade Bulk Fill is available in Unidose™ compules and syringe delivery systems that are suitable for occlusal surfaces. The product offers allows a technique in which a cavity up to 5 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill is offered in one universal shade to optically blend with a range of VITA™ shade guide equivalents. This composite can be polished with a wide variety of polishing discs, rubber cups, and brushes.
SimpliShade™ Bulk Fill Flow:
SimpliShade Bulk Fill Flow is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed to be used as a base or liner in Class I and II restorations and must be overlayed with a composite resin to replace the occlusal surfaces. It is also suitable to be used on nonocclusal-contact surfaces, such as pit and fissures, core build-ups and Class III and V restorations.
SimpliShade Bulk Fill Flow is available in Unidose™ compules and syringe delivery systems. The product allows a technique in which a cavity up to 4 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill Flow is offered in one universal shade to optically blend with a range of VITAM shade guide equivalents. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.
న్. Principle of Operation / Mechanism of Action:
SimpliShade™ Bulk Fill:
SimpliShade Bulk Fill is a high viscosity resin-based nano-hybrid dental restorative that can be lightcured. It is designed to be used after placement of a dental adhesive. Once the bonding procedure is completed, a liner using a low viscosity flowable composite may optionally be placed and light cured according to the manufacturer's instructions prior to placing SimpliShade Bulk Fill. SimpliShade Bulk Fill is intended to be cured by exposure to light waves with a minimum light intensity of 650 mW/cm² and a light wavelength output within the 400-520 nm range, in incremental layers up to 5 mm. The handling behavior of the material is achieved through the addition of a proprietary rheology modifier as well as an optimized balance of the concentration of the filler system with the resin concentration. When irradiated by light, the methacrylate functionalities of the resins and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
SimpliShade™ Bulk Fill Flow:
SimpliShade Bulk Fill Flow is a low viscosity resin-based nano-hybrid dental restorative that can be light-cured. It is designed to be used after placement of a dental adhesive. Once the bonding procedure is completed, a layer of SimpliShade Bulk Fill Flow is placed directly onto the prepared site along the axial and gingival margins. With a brushing action, the material can flow into the marginal interfaces and recesses of the preparation in up to 4mm increments; SimpliShade Bulk Fill Flow is intended to be cured by exposure to light waves with a minimum light intensity of 650 mW/cm² and a light wavelength output within the 400-520 nm range. The handling behavior of the material is achieved through the addition of a proprietary rheology modifier as well as an optimized balance of the concentration of the filler system with the resin concentration. When irradiated by light, the methacrylate functionalities of the resins and fillers undergo, in conjunction with the photoinitiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.
6. Indications for Use:
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Image /page/5/Picture/0 description: The image shows the word "Kerr" in a bold, blue font. The letters are large and spaced closely together. A small trademark symbol is located to the upper right of the word.
SimpliShade™ Bulk Fill is indicated for:
- Direct placement of anterior and posterior restorations.
- Core build-ups.
- Repair of defects in restorations.
SimpliShade™ Bulk Fill Flow is indicated for:
- Base/liner under direct restorations.
- Pit and fissure sealant.
- Restoration of small cavities.
- Class III and V restorations.
- Blocking out undercuts.
- Small core build-ups.
- Repair of resin and acrylic provisional restorations.
7. Description of Substantial Equivalence:
The similarities between the SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow (Subject Device) and the Primary Predicate Device Filtek™ One Bulk Fill Restorative (K163207), Predicate Device #2 Filtek™ Bulk Fill Flowable Restorative (K120453), include the Regulatory Classification, Intended Use of the device, Indications for Use, Mode of Action, Device description, and Clinical condition of use. Furthermore, Technological Characteristics and Performance testing including Biocompatibility testing are similar.
There are no major differences but only minor differences between the SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow (Subject Device) and the Primary Predicate Device Filtek™ One Bulk Fill Restorative (K163207), Predicate Device #2 Filtek™ Bulk Fill Flowable Restorative (K120453). The formulation composition slightly varies and performance test results have slightly different values; however, these minor differences have no impact on the device performances which demonstrate subject devices are substantially equivalent as predicate devices.
Table 1 below compares the SimpliShade™ Bulk Fill, SimpliShade™ Bulk Fill Flow (Subject Devices) and the Primary Predicate Device Filtek™ One Bulk Fill Restorative (K163207), Predicate Device #2 Filtek™ Bulk Fill Flowable Restorative (K120453) with respect to intended use, technological characteristics and performance testing.
| DescriptiveInformation | Subject Device 1 | Subject Device 2 | Predicate Device(Primary) | PredicteDevice #2 | Comparison |
|---|---|---|---|---|---|
| SimpliShade™Bulk Fill(K221255) | SimpliShade™Bulk Fill Flow(K221255) | Filtek™ One BulkFill Restorative(K163207) | Filtek™ Bulk FillFlowable Restorative(K120453) | ||
| Manufacturer | Kerr Corporation | Kerr Corporation | 3M ESPEDental Products | 3M ESPEDental Products | N/A |
| Regulatory Classification | |||||
| Regulation # | 21 CFR 872.3690 | 21 CFR 872.3690 | 21 CFR 872.3690 | 21 CFR 872.3690 | Same asPredicates. |
| RegulationTitle | Tooth Shade ResinMaterial | Tooth Shade ResinMaterial | Tooth Shade ResinMaterial | Tooth Shade ResinMaterial | Same asPredicates. |
| RegulationClass | Class II | Class II | Class II | Class II | Same asPredicates. |
| Product Code | EBF | EBF | EBF | EBF | Same asPredicates. |
| Indications for Use/Intended Use | |||||
| Intended Use | Material, ToothShade, Resin | Material, ToothShade, Resin | Material, ToothShade, Resin | Material, ToothShade, Resin | Same asPredicates. |
| Indicationsfor Use | 1.Direct placementof anterior andposteriorrestorations.2.Core build-ups.3.Repair of defectsin restorations. | 1.Base/liner underdirect restorations.2.Pit and fissuresealant.3.Restoration ofsmall cavities.4.Class III and Vrestorations.5.Blocking outundercuts.6.Small core build-ups.7.Repair of resinand acrylicprovisionalrestorations. | 1.Direct anteriorand posteriorrestorations(including occlusalsurfaces).2.Base/liner underdirect restorations.3.Core build-ups.4.Splinting.5.Indirectrestorationsincluding inlays,onlays and veneers.6.Restorations ofdeciduous teeth.7.Extended fissuresealing in molarsand premolars.8.Repair of defectsin porcelainrestorations,enamel, andtemporaries. | 1.Base under Class Iand II directrestorations.2.Liner under directrestorative materials.3.Pit and fissuresealant.4.Restoration ofminimally invasivecavity preparations(including small, nonstress-bearingocclusal restorations).5.Class III and Vrestorations.6.Undercut blockout.7.Repair of smallenamel defects.8.Repair of smalldefects in estheticindirect restorations.9.Repair of resin andacrylic temporarymaterials.10.As a core build-upwhere at least half thecoronal toothstructure is remainingto provide structuralsupport for thecrown. | SameIndication forUse asPredicateDevices andexpressedthroughsimilar choiceof wording. |
| Technological Characteristics | |||||
| Clinicalcondition ofuse | Dental clinics orsimilar healthcaresettings. | Dental clinics orsimilar healthcaresettings. | Dental clinics orsimilar healthcaresettings. | Dental clinics orsimilar healthcaresettings. | Same asPredicateDevices. |
| Anatomicallocation ofuse | Oral, teeth | Oral, teeth | Oral, teeth | Oral, teeth | Same asPredicateDevices. |
| Principles ofOperation | Tooth shade resin-based dentalrestorative that canbe light-cured by | Tooth shade resin-based dentalrestorative that canbe light-cured by | Tooth shade resin-based dentalrestorative that canbe light-cured by | Tooth shade resin-based dentalrestorative that canbe light-cured by | Same asPredicateDevices. |
| photopolymerization. | photopolymerization. | photopolymerization. | photopolymerization. | ||
| Storage | Store at roomtemperature 2-28°C(36-82°F). | Store at roomtemperature 2-28°C(36-82°F). | Store at roomtemperature 2-27°C. | Store at roomtemperature 2-27°C. | Similar toPredicatedevices. |
| Compatiblewithmethacrylate-based dentaladhesives | Yes | Yes | Yes | Yes | Same asPredicateDevices. |
| Recommended for load-bearingocclusalsurfaces | Yes | No | Yes | No | Same asPredicateDevices. |
| PrimaryPackaging | Syringe andCapsule | Syringe andCapsule | Syringe andCapsule | Syringe and Capsule | Same asPredicateDevices. |
| MaterialComposition | Methacrylateresins, Photo-initiators,Inorganic fillers | Methacrylateresins, Photo-initiators,Inorganic fillers | Methacrylateresins, Photo-initiators,Inorganic fillers | Methacrylate resins,Photo-initiators,Inorganic fillers | Similar toPredicatedevices. |
| ContainingInorganicFillers | Yes | Yes | Yes | Yes | Same asPredicateDevices. |
| PrimaryFiller particlesize range | 40 nm - 0.4 µm | 40 nm - 0.1 µm | 4 nm - 100 nm | 10 nm - 5.0 µm | Similar toPredicatedevices. |
| CuringMechanism | Photo-initiation | Photo-initiation | Photo-initiation | Photo-initiation | Same asPredicateDevices. |
| Intensity(mW/cm²) forcuring | ≥ 650 mW/cm² | ≥ 650 mW/cm² | ≥ 550 mW/cm² | ≥ 550 mW/cm² | Similar toPredicatedevices. |
| Wavelength(nm) forcuring | 400 - 520 nm | 400 - 520 nm | 400 - 500 nm | 400 - 500 nm | Similar toPredicateDevices. |
| Curing Time(sec) | 20 sec (≥ 650mW/cm²) | 20 sec (≥ 650mW/cm²) | At least 20 sec (≥550 mW/cm²) | 20 sec (≥ 550mW/cm²) | Similar toPredicateDevices. |
| Depth ofCure (mm) | Up to 5mm | Up to 4mm | Up to 5mm | Up to 4mm | Similar toPredicateDevices. |
| CompressiveStrength(MPa) | Meet the criteriaper internalstandard | Meet the criteriaper internalstandard | Meet the criteriaper internalstandard | Meet the criteria perinternal standard | Similar toPredicateDevices. |
| Internalstandard>260 Mpa | |||||
| RockwellHardness(RHN)InternalStandard>65 RHN | Meet the criteriaper internalstandard | Meet the criteriaper internalstandard | Meet the criteriaper internalstandard | Meet the criteria perinternal standard | Similar toPredicateDevices. |
| FlexuralStrength(Mpa) | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO 4049requirement | Similar toPredicateDevices. |
| Radio-opacity(mm of AI) | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO 4049requirement | Similar toPredicateDevices. |
| WaterSorption(µg/mm³) | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO 4049requirement | Similar toPredicateDevices. |
| WaterSolubility(µg/mm³) | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO 4049requirement | Similar toPredicateDevices. |
| Sensitivity toambient light | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO 4049requirement | Same asPredicateDevices. |
| ColorStability | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO4049 requirement | Conform to ISO 4049requirement | Same asPredicateDevices. |
| Performance Testing | |||||
| Biocompatability | ISO 10993-1:2018ISO 10993-3:2014ISO 10993-5:2009ISO 10993-6:2016ISO 10993 10:2021ISO 10993-11:2017ISO 10993-12:2021ISO 10993-23:2021ISO 7405:2018 | ISO 10993-1:2018ISO 10993-3:2014ISO 10993-5:2009ISO 10993-6:2016ISO 10993-10:2010ISO 10993-11:2017ISO 10993-12:2021ISO 10993-23:2021ISO 7405:2018 | ISO 10993-1:2009ISO 10993-3:2014ISO 10993-5:2009ISO 10993-6:2007ISO 10993-10:2010ISO 10993-11:2006ISO 10993-12:2012ISO 7405:2008/AMD1 2013 | ISO 10993-1:2009ISO 10993-3:2003ISO 10993-5:2009ISO 10993-6:2007ISO 10993-10:2010ISO 10993-11:2006ISO 10993-12:2012ISO 7405:2008 | Similar toPredicatedevices. |
| Dentistry -Polymer-basedrestorativematerials | ISO 4049:2019 | ISO 4049:2019 | ISO 4049:2009 | ISO 4049:2009 | Similar toPredicatedevices. |
Table 1: Device Comparison Table
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- Non-Clinical Test Data:
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Performance bench tests according to ISO 4049 for Dental Polymer-Based Restorative Materials have been conducted to determine conformance in regards of flexural strength, sensitivity to light, water sorption, water solubility, depth of cure, radio-opacity, and color stability etc. Additional tests such as compressive strength, diametral tensile strength, rockwell hardness, and volumetric shrinkage, wear, and shrinkage stress have been performed to compare the subject devices and predicate devices. The data from these tests demonstrate that the subject devices SimpliShade Bulk Fill and SimpliShade Bulk Fill Flow are substantially equivalent to the predicate devices 3M Filtek One Bulk Fill Restorative and 3M Filtek Bulk Fill Flowable Restorative.
9. Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the subject devices.
10. Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the SimpliShade™ Bulk Fill and SimpliShade™ Bulk Fill Flow are deemed to be substantially equivalent to the predicate devices.
§ 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.