(266 days)
Indications for use:
*Class III and V restorations
-
- Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
*Base/liner under direct restorations
*Repair of small defects in esthetic indirect restorations
*Pit and fissure sealant
*Undercut blockout
*Repair of resin and acrylic temporary materials
- Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
Apoller Flow-Light Cure Flowable Composite is a low viscosity light activated flowable nanocomposite device. The device is comprised of a syringe with dispensing tips. It consists of methmethacrylate monomers, inorganic fillers and nanoparticles. Apoller Flow Light Cure Flowable Composite contains BisGMA, UDMA, TEGDMA, photo initiator, stabilizer and inorganic fillers including barium glass powder, strontium glass powder and nanosilica. The filler loading is about 56% by weight. The particle size varies from 0.03 to 1 micron. Apoller Flow Light Cure Flowable Composite series is packed in a plastic syringe with a bend metal injection needle heads for ease of usage, its model is Flowable and comes with Refill Syringe of 3.0g /syringe and 1.5 g /syringe. It is available in a variety of 15 tooth-colored shades.
The provided FDA 510(k) summary for the "Apoller Flow Light Cure Flowable Composite" describes its substantial equivalence to a predicate device, "Filtek™ Supreme Ultra Flowable Restorative." The document outlines various performance aspects but primarily focuses on demonstrating equivalence to the predicate device rather than establishing specific acceptance criteria for the new device and then proving it meets those criteria with a standalone study. Instead, it compares the new device's properties to existing standards and the predicate device.
Here's an attempt to extract the requested information based on the provided text. It's important to note that many of the specific details regarding study design, sample sizes for test/training sets, expert qualifications, and adjudication methods (which are typical for AI/software device studies) are not present in this type of submission for a dental composite. This document focuses on material properties and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly that the "Apoller Flow Light Cure Flowable Composite" performs comparably to the "Filtek™ Supreme Ultra Flowable Restorative" predicate device and meets relevant ISO standards. The performance is reported in terms of various physical properties and biocompatibility, demonstrating equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Apoller Flow Light Cure Flowable Composite) |
|---|---|---|
| Physical Properties | Comparable to predicate device (Filtek™ Supreme Ultra Flowable Restorative) per ISO 4049 | - Sensitivity to ambient light: Compared, results demonstrate substantial equivalence.- Depth of cure (mm): Compared, results demonstrate substantial equivalence.- Flexural Strength (MPa): Compared, results demonstrate substantial equivalence. |
| - Water sorption (µg/mm³): Compared, results demonstrate substantial equivalence.- Water solubility (µg/mm³): Compared, results demonstrate substantial equivalence.- Shade Color stability after irradiation and water sorption: Compared, results demonstrate substantial equivalence. | ||
| - Radio-opacity (mm): Compared, results demonstrate substantial equivalence. | ||
| Biocompatibility | Substantially equivalent to predicate device per ISO 7405, ISO 10993-1, -3, -5, -11 | Concluded to be substantially equivalent to the primary predicate device based on comparative test report. |
| Technological | Equivalent to predicate device | - Intended Use: Equivalent- Method of Polymerization: Equivalent (Light Cured)- Chemical composition: Equivalent (Glass filled Methmethacrylate monomer resins, Nanoparticle) |
| - Mechanical/physical properties: Equivalent (Low viscosity, Flowable)- Application process and use: Similar- Camphorquinone / amine photoinitiator system: Equivalent | ||
| - Methacrylate-based resin matrix: Equivalent- Silane treated fillers: Equivalent- Bonded with permanent dental adhesive: Equivalent |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the "comparison testing" of physical properties. These would typically be determined by the specific ISO standards (e.g., ISO 4049) applied to dental materials, which involve a certain number of specimens for each test. The data provenance is from non-clinical performance testing conducted by the manufacturer (SINO-DENTEX CO., LTD., Changchun, China). The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not as part of an ongoing prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and submission. Dental composite materials do not typically involve expert review for "ground truth" in the same way an AI diagnostic image analysis device would. The "ground truth" for material properties is established through standardized laboratory testing (e.g., ISO 4049).
4. Adjudication method for the test set
This information is not applicable. There is no adjudication process involving multiple human readers for validating the performance of a dental material.
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
An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, not for dental composite materials.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims (physical properties, biocompatibility) is based on standardized laboratory testing methods (e.g., ISO 4049 for physical properties; ISO 7405, ISO 10993-1, -3, -5, -11 for biocompatibility). The performance of the new device is then compared against that of the predicate device and the requirements of these standards.
8. The sample size for the training set
This information is not applicable. The device is a physical material, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As the device is a physical material, there is no training set or ground truth in the context of machine learning.
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Image /page/0/Picture/0 description: The image shows 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.
November 14, 2018
Greenway YW LLC % Maritza Moncayo VP Regulatory Affairs Iris Global LLC 40931 W. Hopper Dr. Maricopa, Arizona 85138
Re: K180463
Trade/Device Name: Apoller Flow Light Cure Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 23, 2018 Received: August 29, 2018
Dear Maritza Moncayo:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Mary S. Mary S. Runner -S3 Runner - S3 12:23:42 -05'00' 12:23:42 -05'00'
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
APOLLER FLOW LIGHT CURE FLOWABLE COMPOSITE
Indications for Use (Describe)
Indications for use:
*Class III and V restorations
-
- Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
*Base/liner under direct restorations
- Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
*Repair of small defects in esthetic indirect restorations
*Pit and fissure sealant
*Undercut blockout
*Repair of resin and acrylic temporary materials
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 a green logo with the letters "GW" in a stylized font. There are three horizontal lines running through the letters, giving them a striped appearance. A small "R" in a circle is located in the upper right corner of the logo, indicating a registered trademark.
Greenway YW LLC
5. 510 (k) Summary
K180463 - Apoller Flow Light Cure Flowable Composite
Date prepared: November 09, 2018
Applicant, Contact and Manufacturer Information: 5.1.
| Applicant Information: | GREENWAY YW LLC |
|---|---|
| 21 N. Skokie Hwy, Suite 204 | |
| Lake Bluff, II. 60044, | |
| United States of America | |
| Tel: 1(847) 525-5258 | |
| Fax: 1(847) 478-5258 | |
| Contact: Scott Yin | |
| Email: yinradtech@gmail.com |
Maritza Moncayo Contact Person: Regulatory Affairs IRIS GLOBAL, LLC 40931 W. Hopper Dr. Maricopa, AZ 85138 Phone/Fax: 1 (847)-226-9176 Email: mmoncayo@irisgra.com
- SINO-DENTEX CO., LTD. Manufacturer: 12357E Jinhu Road, High-Tech Development District, Changchun, China 130103 Contact: Pengtao Yan Email: dentex-ypt@163.com Tel: (086) 431-87855156 Fax: (086) 431-87855157
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Image /page/4/Picture/0 description: The image shows a green logo with the letters "GW" in a stylized font. There are three horizontal lines below the letters, giving the impression of a solid base. A small registered trademark symbol is located in the upper right corner of the logo. The logo is simple and modern.
5.2. General Device Information:
Greenway is providing general product information and classification per FDA guidelines, in Table 1.
Table 1.- Product Classification
| Device Trade Name(Commercial): | Apoller Flow Light Cure Flowable Composite |
|---|---|
| Common Name: | Tooth Shade Resin Material |
| Classification: | 21 CFR 872.3690 |
| Regulation Name: | Tooth Shade Resin Material |
| Regulatory Class: | Class II |
| Product Code: | EBF |
5.3. Primary Predicate Device Information to which Equivalence is Claimed:
The primary predicate device is Filtek™ Supreme Ultra Flowable Restorative, summary of the predicate device in Table 2:
| Device Trade Name | Filtek™ Supreme Ultra Flowable Restorative |
|---|---|
| Common Name | Tooth shade resin material |
| 510 (k) Number | K100235 |
| Decision Date | May 12, 2010 |
| Manufacturer | 3M Company |
| Classification | 21 CFR 872.3690 |
| Product Code | EBF |
| Class | II |
Table 2- Summary Predicate Device
5.4. Device Description:
Apoller Flow-Light Cure Flowable Composite is a low viscosity light activated flowable nanocomposite device. The device is comprised of a syringe with dispensing tips. It consists of methmethacrylate monomers, inorganic fillers and nanoparticles. Apoller Flow Light Cure Flowable Composite contains BisGMA, UDMA, TEGDMA, photo initiator, stabilizer and inorganic fillers including barium glass powder, strontium glass powder and nanosilica. The filler loading is about 56% by weight. The particle size varies from 0.03 to 1 micron. Apoller Flow Light Cure Flowable Composite series is packed in a plastic syringe with a bend metal injection needle heads for ease of usage, its model is Flowable and comes with Refill Syringe of 3.0g /syringe and 1.5 g /syringe. It is available in a variety of 15 tooth-colored shades.
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Image /page/5/Picture/0 description: The image shows a green logo with the letters "GW" in a stylized font. The letters are bold and have horizontal lines running through them, creating a striped effect. There is a registered trademark symbol in the upper right corner of the logo. The logo is simple and modern.
Apoller Flow - Light Cure Flowable Composite Abbreviated 510(k) Notification
Greenway YW LLC
5.5. Indications for Use:
- Class III and V restorations
- . Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
- Base/liner under direct restorations
- Repair of small defects in esthetic indirect restorations .
- Pit and fissure sealant
- Undercut blockout
- . Repair of resin and acrylic temporary materials
5.6. Technological Characteristics:
The assessment of the technological characteristic of the Apoller Flow Light Cure Flowable Composite and of the predicate device "Filtek™ Supreme Ultra Flowable Restorative" are equivalent as the currently marketed predicate device manufactured by 3M Company-3M ESPE Dental Products, as described in Table 3.
Both Apoller Flow Light Cure Flowable Composite and primary predicate device are very similar in all comparison areas including chemical composition, intended use, method of polymerization, mechanical properties and application process and use. A slight difference is the filler loading which impact the flowability of the composite, doesn't influence the application and all physical properties.
| TechnologicalCharacteristics/ Properties | Apoller Flow LightCure FlowableComposite | Filtek™ SupremeUltra FlowableRestorative | Discussion |
|---|---|---|---|
| Intended use | *Class III and Vrestorations*Restoration ofminimally invasivecavity preparations(including small, nonstress-bearingocclusalrestorations)*Base/liner underdirect restorations*Repair of smalldefects in estheticindirect restorations | *Class III and Vrestorations*Restoration ofminimally invasivecavity preparations(including small, nonstress-bearingocclusal restorations)*Base/liner underdirect restorations*Repair of smalldefects in estheticindirect restorations | Equivalent toprimary predicatedevice |
Table 3.- Technological Characteristics
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Image /page/6/Picture/0 description: The image shows a logo with the letters 'GW' in a stylized, green font. The letters are bold and slightly overlapping, with horizontal lines running through them, creating a sense of depth or texture. A registered trademark symbol (®) is positioned in the upper right corner of the logo.
Greenway YW LLC
Apoller Flow - Light Cure Flowable Composite Abbreviated 510(k) Notification
| TechnologicalCharacteristics/ Properties | Apoller Flow LightCure FlowableComposite | Filtek™ SupremeUltra FlowableRestorative | Discussion |
|---|---|---|---|
| *Pit and fissuresealant *Undercutblockout *Repair ofresin and acrylictemporary materials | *Pit and fissuresealant *Undercutblockout *Repair ofresin and acrylictemporary materials | ||
| Method of Polymerization | Light Cured | Light Cured | Equivalent toprimary predicatedevice |
| Chemical composition | Glass filledMethmethacrylatemonomer resinsNanoparticleFiller loading-56 %by weight | Glass filledMethmethacrylatemonomer resinsNanoparticleFiller loading-65 %by weight | Equivalent toprimary predicatedevice |
| Mechanical/physicalproperties | Low viscosityFlowable | Low viscosityFlowable | Equivalent toprimary predicatedevice |
| Application process and use | Similar | Similar | Equivalent toprimary predicatedevice |
| Camphorquinone / aminephotoinitiator system | Equivalent | Equivalent | |
| Methacrylate-based resinmatrix | Equivalent | Equivalent | |
| Silane treated fillers | Equivalent | Equivalent | |
| Bonded with permanentdental adhesive | Equivalent | Equivalent |
5.7. Summary of Physical Properties:
The Physical properties of this 510(k) submission includes data of the comparison testing per ISO4049, performed to the Apoller Flow Light Cure Flowable Composite and the primary predicate device "Filtek™ Supreme Ultra Flowable Restorative". The properties evaluated included Sensitivity to ambient light, Depth of cure (mm), Flexural Strength (MPa), Water sorption (µg/mm³), Water solubility(µg/mm³), Shade Color stability after irradiation and water sorption, Radio-opacity (mm). Based on the tests performed the results demonstrate substantial equivalence to the primary predicate device.
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Image /page/7/Picture/0 description: The image shows a green logo with the letters "GW" in a stylized font. The letters are connected and have horizontal lines running through them. There is a small registered trademark symbol in the upper right corner of the logo.
Apoller Flow - Light Cure Flowable Composite Abbreviated 510(k) Notification
Greenwav YW LLC
5.8. Biocompatibility
Evaluation of biocompatibility was conducted using ISO7405, ISO 10993-1; ISO10993-3; ISO10993-5:2009 and ISO10993-11 to determine the biocompatibility of Apoller Flow Light Cure Flowable Composite. Based on the comparative test report it was concluded that Apoller Flow Light Cure Flowable Composite is substantial equivalent to the primary predicate device.
5.9. Non-Clinical Performance Testing:
Based on the technological characteristics, physical property and biocompatibility comparisons between Apoller Flow Light Cure Flowable Composite and the primary predicate device, it is demonstrated that Apoller Flow Light Cure Flowable Composite is equivalent to 3M Filtek™ Supreme Ultra Flowable Restorative.
Conclusion - Substantial Equivalence: 5.10.
The information provided in the 510(k) submission shows that Apoller Flow Light Cure Flowable Composite is substantially equivalent to the primary predicate device Filtek™ Supreme Ultra Flowable Restorative, the two products have the same indications for use, are composed of similar materials, have the same intended use, physical properties and technological characteristics as well as a similar design.
§ 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.