(85 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of a dental restorative material, with no mention of AI or ML.
No.
A therapeutic device is typically involved in the treatment or prevention of a disease or condition by directly affecting the body's functions or structure. This device is a restorative material used to fill cavities and seal sensitive areas, which falls under the category of restoring normal function or appearance rather than treating a disease.
No
The device is a restorative material used for dental fillings, not for diagnosing conditions. Its intended uses include restoring cavities, blocking undercuts, and sealing hypersensitive areas, all of which are treatment-oriented.
No
The device description clearly states it is a "polymer-based restorative material" and is contained in a "plastic syringe" with associated hardware components. This indicates a physical material and delivery system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (restoration of cavities, blocking undercuts, sealing hypersensitive areas) are all procedures performed directly on the patient's teeth. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a material used for dental restorations, applied directly to the teeth. This is consistent with a medical device used for treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on material properties relevant to dental restorations (flexural strength, depth of polymerization, water absorption, etc.) and biocompatibility, not diagnostic accuracy metrics like sensitivity or specificity.
This device is clearly a dental restorative material, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Enaden Flow is intended for use in :
- Restoration of class I~V cavities
- Blocking out of undercuts
- Sealing hypersensitive areas
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Enaden Flow is a polymer-based restorative material. Enaden Flow is visible light-cured, radiopaque flowable composite and it is easy to handle, ready to be applied to restorations directly. The Enaden Flowl is available in 5 shades: A1, A2, A3, A3.5, and B2 (according to VITAPAN® classic shade guide). The device is used for the restorations of both anterior and posterior teeth. The device is contained in a plastic syringe and the system includes a plunger, disposable needle, protective cap, and a holder for direction control of the needle.
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 following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- 1SO 4049 Flexural Strength, Sensitivity to Ambient Light, Depth of polymerization, Water · Absorption/Solubility, Radio-opacity, Color/ Color Stability
- ISO 9917 Compressive Strength
- ISO 10993-5 Cytotoxicity
- ISO 10993-10 Skin sensitization test, Oral mucous irritation test
- ISO 10993-11 Short term systemic toxicity test
- Other bench testing Shelf life, Appearance, Volume, and Packaging tests
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
(K140976)
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
07/08/2014 Date: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1. Applicant / Submitter:
KM Corporation 727 , Seoun-ro, Miyang-myeon, Anseong-si, Gyeonggi-do, 456-843, Republic of Korea
Tel: +82-31-678-3451 Fax: +82-31-678-3489
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
3. Device:
1
Proprietary Name: Enaden Flow Common Name: Light-cured Flowable Restorative Material Classification Name: Tooth Shade Resin Material Classification: Class II, 21 CFR 872.3690 EBF Classification Product Code:
4. Predicate Device:
Tetric Evocream by Ivoclar Vivadent, Inc. (K042819) G-aenial Universal Flo (GCUC-505) by GC AMERICA, Inc. (K091388) Denfil Flow by VERICOM Co., Ltd. (K060637)
1
1
Device Description: 5.
Enaden Flow is a polymer-based restorative material. Enaden Flow is visible light-cured, radiopaque flowable composite and it is easy to handle, ready to be applied to restorations directly. The Enaden Flowl is available in 5 shades: A1, A2, A3, A3.5, and B2 (according to VITAPAN® classic shade guide). The device is used for the restorations of both anterior and posterior teeth. The device is contained in a plastic syringe and the system includes a plunger, disposable needle, protective cap, and a holder for direction control of the needle.
6. Intended Use:
if
The Enaden Flow is intended for use in:
-
- Restoration of class I~V cavities
-
- Blocking out of undercuts
-
- Sealing hypersensitive areas
7. Performance Data(Non-Clinical):
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- = 1SO 4049 Flexural Strength, Sensitivity to Ambient Light, Depth of polymerization, Water · Absorption/Solubility, Radio-opacity, Color/ Color Stability
- = ISO 9917 Compressive Strength
- · ISO 10993-5 Cytotoxicity
- ISO 10993-10 Skin sensitization test, Oral mucous irritation test
- · ISO 10993-11 Short term systemic toxicity test
- · Other bench testing Shelf life, Appearance, Volume, and Packaging tests
8. Substantial Equivalence
Enaden Flow is substantially equivalent to the predicate devices described herein with respect to intended use, device design, main raw material, accessory components, and delivery method. Also the curing mechanism of the subject device and the predicate devices is substantially equivalent in principle.
The difference is the compositions of some additives; however, the biocompatibility and the performance testing results show that this difference does not raise issues in safety and effectiveness.
2
| Subject Device | Predicate Devices | |||
|---|---|---|---|---|
| 510(K) | ||||
| Number | K140976 | K042819 | K091388 | K060637 |
| Device Name | Enaden Flow | Tetric Evocream | G-aenial Universal Flo | |
| (GCUC-505) | Denfil Flow | |||
| Manufacturer | KM Corporation | Ivoclar Vivadent, Inc | GC AMERICA, INC | VERICOM Co., Ltd. |
| Product Code | EBF | EBF | EBF | EBF |
| Design | Image: Enaden Flow syringe | Image: Tetric Evocream applicator | Image: G-aenial Universal Flo applicators | Image: Denfil Flow syringe |
| Intended Use | The Enaden Flow is | |||
| intended for use in : |
- Restoration of class I~V
cavities. - Blocking out of
undercuts. - Sealing hypersensitive
areas | 1) Anterior restorations
(Class III, IV) - Class V restorations
- Restorations in the
posterior region(Class I, II) - Veneering of discolored
anterior teeth - Splinting of mobile teeth
- Repair of composite and
ceramic veneers. | 1) Restoration of class I-V
cavities. - Restoration of root surface
caries. - Restoration of deciduous
teeth. - Filling tunnel shaped
cavities. - Sealing hypersensitive areas
- Liner/base/filling in cavity
undercuts - Sealant
- Splinting mobile teeth
- Additions to composite
restorations. | 1) Class V restorations - Anterior
restorations(Class III,IV) - Small posterior
restorations - Restorative therapy for
mini-cavities of all types. - Extended fissures sealing
in molars and premolars. - Repair of
composite/ceramic veneers. - Blocking out of
undercuts |
| Material
Composition | Barium Glass, Urethane
Dimethacrylate(UDMA),
Triethylene Glycol
Dimethacrylate(TEGDMA)
, Bis-GMA, etc | Barium Glass,
Dimethacrylates(UDMA), etc | Triethylene Glycol
Dimethacrylate(TEGDMA),
Urethane
Dimethacrylate(UDMA), etc | Bis-GMA, Barium
aluminosilicate.
Triethylene Glycol
Dimethacrylate(TEGDMA,
etc |
| Human Factors | Ready to use dispensing
system | Ready to use dispensing
system | Ready to use dispensing
system | Ready to use dispensing
system |
| Biocompatibili | Biocompatible, conforming | Biocompatible, conforming to | Biocompatible, conforming to | Biocompatible, conforming |
| ty | to ISO 10993 | ISO 10993 | ISO 10993 | to ISO 10993 |
| Physical
Properties | Meets ISO 4049
specifications | Meets ISO 4049 specifications | Meets ISO 4049 specifications | Meets ISO 4049
specifications |
3
9. Conclusion:
Based on the testing results, KM Corporation concludes that the Enaden Flow is substantially equivalent to the predicate devices.
·
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2014
KM Cornoration C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA Incorporated 2651 E Chapman Avenue Suite 110 Fullerton, CA 92831
Re: K140976
Trade/Device Name: Enaden Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 7, 2014 Received: April 16, 2014
Dear Ms. Chung:
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. 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 warrantics. 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.
5
Page 2 - Ms. Priscilla Chung
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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Digitally signed by Richard C. Chapman -S Date: 2014.07.10 14:08:37 -04'00'
for
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Enaden Flow
Indications for Use (Describe) The Enaden Flow is intended for use in :
-
Restoration of class I~V cavities
-
Blocking out of undercuts
-
Sealing hypersensitive areas
Type of Use (Select one or both, as applicable)
[区] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
。 彩 FOR FDA USE ONLY .
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Image /page/6/Picture/15 description: The image shows the text "Sheena A. Green's 2014.07.10 11:35:45 -04'00'". The text appears to be a timestamp or record of some kind. The text is black and the background is white.