(90 days)
No
The summary describes a dental restorative material and its physical properties, with no mention of AI or ML.
No
This device is a flowable restorative material used for filling and repairing dental structures, which is a structural and aesthetic function, not directly therapeutic.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as a material for restorations and sealants, and a liner, which are all therapeutic or restorative functions, not diagnostic ones. There is no mention of it being used to identify or detect medical conditions.
No
The device description clearly states it is a "low viscosity, visible-light activated, flowable" material packaged in syringes and containing various chemical components and fillers. This describes a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct dental restorations and sealants, which are applied directly to the patient's teeth. IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a flowable restorative material used for filling cavities and sealing surfaces. This is a therapeutic/restorative device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health condition.
- Performance Studies: The performance studies listed focus on the physical and mechanical properties of the material (depth of cure, strength, water sorption, etc.), which are relevant to its use as a dental restorative, not its diagnostic capabilities.
This device is clearly a dental restorative material, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
- . Base under Class I and II direct restorations
- . Pit and fissure sealant
- . Class III and V restorations
- . Repair of resin, porcelain and acrylic temporary materials
- . Liner under direct restorative materials
Product codes
EBF, EBC
Device Description
Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent enabling up to a depth of 3~5mm at a time. Jet Flow Bulk is packaged in disposable tips and two syringes that include restorative materials. The shades offered with Jet Flow Bulk are Universal(U), Dentin(D), A1, A2, A3. Jet Flow Bulk contains bisGMA, UDMA, bisEMA. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.053 to 6.76 microns and silica with a particle size range of 0.04 to 0.452 um. The inorganic filler loading is approximately 35.6 vol.% (61.0wt.%).
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
Dentist
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)
Non-clinical Testing:
- Biocompatibility Tests according to EN ISO 10993-3:2014, EN ISO 10993-5:2009, EN ISO 10993-. 6:2016, EN ISO 10993-10:2023, EN ISO 10993-11:2018, EN ISO 10993-23:2021, EN ISO 7405:2018
- Performance tests such as Sensitivity of ambient light, Depth of cure, Shade, Color Stability, Flexural strength, Water Sorption, Solubility and Radio-opacity according to EN ISO 4049:2009.
- Shelf Life test: ASTM-F1980
Key Results:
- Depth of cure: > 2.5 mm (U: 5 mm, D: 5 mm, A1: 3.27 mm, A2: 3.31 mm, A3: 3.07 mm)
- Flexural strength: >= 80MPa (106.26MPa)
- Water sorption:
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2024
META Biomed Co., Ltd. % April Lee Consultant Withus Group, Inc. 106 Superior Irvine. California 92620
Re: K242014
Trade/Device Name: Jet Flow Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, EBC Dated: July 10, 2024 Received: July 10, 2024
Dear April Lee:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
Submission Number (if known)
K242014
Device Name
Jet Flow Bulk
Indications for Use (Describe)
- . Base under Class I and II direct restorations
- . Pit and fissure sealant
- . Class III and V restorations
- . Repair of resin, porcelain and acrylic temporary materials
- . Liner under direct restorative materials
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K24204 - 510(k) Summary
Submitter
META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: ef1459@metabiogw.bizmeka.com Phone: +82-43-230-8841 Fax: +82-43-217-1983
Device Information
- Trade Name: Jet Flow Bulk ●
- Classification Name: Material, Tooth Shade, Resin 0
- Common Name: Tooth shade resin material
- Product Code: EBF
- Panel: Dental
- Regulation Number: 21 CFR 872.3690
- Device Class: Class II
- Date prepared: 06/26/2024
Predicate Devices:
- o K120453, FILTEK BULK FILL FLOWABLE RESTORATIVE by 3M ESPE DENTAL PRODUCTS
Device Description
-
Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent enabling up to a depth of 3~5mm at a time.
-
Jet Flow Bulk is packaged in disposable tips and two syringes that include restorative materials.
-
The shades offered with Jet Flow Bulk are Universal(U), Dentin(D), A1, A2, A3.
-
Jet Flow Bulk contains bisGMA, UDMA, bisEMA.
-
The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.053 to 6.76 microns and silica with a particle size range of 0.04 to 0.452 um. The inorganic filler loading is approximately 35.6 vol.% (61.0wt.%).
Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971
Official Correspondent
Fax: 1-909-460-8122
5
Indications for Use
- Base under Class I and II direct restorations ●
- Pit and fissure sealant
- . Class III and V restorations
- Repair of resin, porcelain and acrylic temporary materials ●
- o Liner under direct restorative materials
Non-clinical Testing
The following testing was conducted on our subject device:
- Biocompatibility Tests according to EN ISO 10993-3:2014, EN ISO 10993-5:2009, EN ISO 10993-. 6:2016, EN ISO 10993-10:2023, EN ISO 10993-11:2018, EN ISO 10993-23:2021, EN ISO 7405:2018
- Performance tests such as Sensitivity of ambient light, Depth of cure, Shade, Color Stability, ● Flexural strength, Water Sorption, Solubility and Radio-opacity according to EN ISO 4049:2009.
- Shelf Life test: ASTM-F1980 .
Summary of Technological Characteristics:
The subject device and the predicate device have the same intended use and have similar technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.
The subject device is different from the predicate devices in raw materials, however, the test results provided in this submission support that it is substantially equivalent to the predicate device.
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | Meta Biomed Co., Ltd. | 3M ESPE DENTAL PRODUCTS |
| Device Name | Jet Flow Bulk | FILTEK BULK FILL FLOWABLE |
| RESTORATIVE | ||
| 510(k) Number | N/A | K120453 |
| Classification | ||
| Name | Material, Tooth Shade, Resin | Material, Tooth Shade, Resin |
| Product Code | EBF | EBF |
| Regulation | ||
| Number | 21 CFR 872.3690 | 21 CFR 872.3690 |
| Indications for | ||
| use | • Base under Class I and II direct | |
| restorations | ||
| • Pit and fissure sealant | ||
| • Class III and V restorations | ||
| • Repair of resin, porcelain and acrylic | ||
| temporary materials | • Base under Class I and II direct restorations | |
| • Liner under direct restorative materials | ||
| • Pit and fissure sealant | ||
| • Restoration of minimally invasive cavity | ||
| preparations (including small, non-stress- | ||
| bearing occlusal restorations) | ||
| • Class III and V restorations | ||
| • Liner under direct restorative | ||
| materials | • Undercut blockout | |
| • Repair of small enamel defects | ||
| • Repair of small defects in esthetic indirect | ||
| restorations | ||
| • Repair of resin and acrylic temporary | ||
| materials | ||
| • As a core build-up where at least half the | ||
| coronal tooth structure is remaining to | ||
| provide structural support for the crown | ||
| Raw Material | Resin: |
- Bis-EMA,
- Bis-GMA,
- UDMA,
- TCDDMA. | Resin:
- Bis-EMA,
- Bis-GMA,
- UDMA,
- Substituted Dimethacrylate,
- TEGDMA. |
| | Filler: - Barium Glass,
- Feldspar,
- Silica,
- Ytterbium fluoride. | Filler:
- Silane treated ceramic,
- Ytterbium fluoride, |
| | Total inorganic filler: 61% weight,
35.6% volume | Total inorganic fillers: 64.5% weight, 42.5%
volume. |
| | Principle of
Operation | Jet Flow Bulk contains bisGMA,
UDMA, bisEMA. The fillers are a
combination of ytterbium trifluoride
filler with a range of particle sizes
from 0.053 to 6.76 microns and silica
with a particle size range of 0.04 to
0.452 µm. The inorganic filler loading
is approximately 35.6 vol.%
(61.0wt.%).
When irradiated by light, the
methacrylate functionalities of the
resins and fillers undergo, in
conjunction with the photo initiator
system, a light induced polymerization
to form a hard composite that is
bonded to the tooth structure with a
permanent dental adhesive. |
| | | Performance
Standard |
| | Radiopaque | O |
| | Depth of cure | > 2.5 mm
(U: 5 mm, D: 5 mm, A1: 3.27 mm, A2:
3.31 mm, A3: 3.07 mm) |
6
7
| Flexural
| strength | ≥ 80MPa (106.26MPa) | 126.5MPa |
|---|---|---|
| Water sorption | ||
| & Solubility | ≤ 40 µg/mm³ (13.48 µg/mm³) | (26.52 µg/mm³) |
| ≤ 7.5 µg/mm³ (1.14 µg/mm³) | (5.98 µg/mm³) | |
| Sensitivity to | ||
| ambient light | Physically homogeneous(Pass) | Physically homogeneous |
| Shade and | ||
| Colour stability | Shade: The shade of the sample shall | |
| be matched with shade guide.(Pass) | ||
| Colour Stability: The sample shall be | ||
| no colour change.(Pass) | The shade of the sample shall be matched with | |
| shade guide. | ||
| The sample shall be no colour change. | ||
| Biocompatibilit | ||
| y | Yes | Yes |
| Intended | ||
| Operator | Dentist | Dentist |
| Sterility | Non-sterile | Non-sterile |
| Shelf Life | 3 years | 3 years |
Conclusion:
Based on documentation supplied with this submissions drawn from the testing results demonstrate that the subject device, Jet Flow Bulk is substantially equivalent to our legally marketed predicate device.