(266 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a flowable composite, with no mention of AI or ML capabilities.
No
The device is a dental restorative material used for various applications like fillings, liners, and sealants. Its function is to restore or repair tooth structure, not to treat or cure a disease or condition itself.
No
Explanation: The device is a flowable composite material used for restorations and other dental procedures, not for diagnosing conditions or diseases. Its intended use is for treatment, not diagnosis.
No
The device description clearly states it is a "low viscosity light activated flowable nanocomposite device" comprised of a syringe, dispensing tips, and various chemical components (monomers, fillers, nanoparticles). This describes a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to dental restorations and procedures performed directly on the patient's teeth (filling cavities, sealing pits, repairing materials). This is a therapeutic or restorative function, not a diagnostic one.
- Device Description: The description details a material used for filling and repairing teeth. It's a physical material applied to the patient.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the body (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition based on such testing.
- Performance Studies: The performance studies focus on physical properties relevant to a dental restorative material (depth of cure, strength, water sorption, etc.), not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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)
Product codes
EBF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
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
4
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.
5
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.
| Technological
Characteristics/ Properties | Apoller Flow Light
Cure Flowable
Composite | Filtek™ Supreme
Ultra Flowable
Restorative | Discussion |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Intended 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 | *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 | Equivalent to
primary predicate
device |
Table 3.- Technological Characteristics
6
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
| Technological
Characteristics/ Properties | Apoller Flow Light
Cure Flowable
Composite | Filtek™ Supreme
Ultra Flowable
Restorative | Discussion |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | *Pit and fissure
sealant *Undercut
blockout *Repair of
resin and acrylic
temporary materials | *Pit and fissure
sealant *Undercut
blockout *Repair of
resin and acrylic
temporary materials | |
| Method of Polymerization | Light Cured | Light Cured | Equivalent to
primary predicate
device |
| Chemical composition | Glass filled
Methmethacrylate
monomer resins
Nanoparticle
Filler loading-56 %
by weight | Glass filled
Methmethacrylate
monomer resins
Nanoparticle
Filler loading-65 %
by weight | Equivalent to
primary predicate
device |
| Mechanical/physical
properties | Low viscosity
Flowable | Low viscosity
Flowable | Equivalent to
primary predicate
device |
| Application process and use | Similar | Similar | Equivalent to
primary predicate
device |
| Camphorquinone / amine
photoinitiator system | Equivalent | Equivalent | |
| Methacrylate-based resin
matrix | Equivalent | Equivalent | |
| Silane treated fillers | Equivalent | Equivalent | |
| Bonded with permanent
dental 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.
7
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.