ENADEN FLOW

K140976 · Km Corporation · EBF · Jul 10, 2014 · Dental

Device Facts

• Record ID: K140976
• Device Name: ENADEN FLOW
• Applicant: Km Corporation
• Product Code: EBF · Dental
• Decision Date: Jul 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Enaden Flow is intended for use in: 1) Restoration of class I~V cavities 2) Blocking out of undercuts 3) Sealing hypersensitive areas

Device Story

Enaden Flow is a visible light-cured, radiopaque, polymer-based flowable composite restorative material. It is supplied in a plastic syringe with a plunger, disposable needle, and protective cap. The device is used by dental professionals in a clinical setting for the restoration of anterior and posterior teeth, including class I-V cavities, blocking out undercuts, and sealing hypersensitive areas. The material is applied directly to the tooth structure and cured using a dental light-curing unit. By providing a flowable, aesthetic restorative material, it enables clinicians to repair tooth structure, improve tooth appearance, and address sensitivity, thereby restoring dental function and patient comfort.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 4049 (flexural strength, depth of cure, water absorption/solubility, radio-opacity, color stability), ISO 9917 (compressive strength), and ISO 10993 (cytotoxicity, skin sensitization, oral irritation, systemic toxicity). Results support substantial equivalence.

Technological Characteristics

Polymer-based composite containing Barium Glass, UDMA, TEGDMA, and Bis-GMA. Visible light-cured. Radiopaque. Supplied in a syringe-based dispensing system. Tested to ISO 4049, ISO 9917, and ISO 10993 standards.

Indications for Use

Indicated for patients requiring restoration of class I-V cavities, blocking out of undercuts, or sealing of hypersensitive areas. For prescription use only.

Regulatory Classification

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.

Predicate Devices

• Tetric Evocream (K042819)
• G-aenial Universal Flo (GCUC-505) (K091388)
• Denfil Flow (K060637)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone]

#### 2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Fax: [phone] Phone: [phone] Email: [e-mail]

#### 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

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#### 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:

- 1) Restoration of class I~V cavities
- 2) Blocking out of undercuts
- 3) 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.

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| | Subject Device | Predicate Devices | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)<br>Number | K140976 | K042819 | K091388 | K060637 |
| Device Name | Enaden Flow | Tetric Evocream | G-aenial Universal Flo<br>(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<br>intended for use in :<br>1) Restoration of class I~V<br>cavities.<br>2) Blocking out of<br>undercuts.<br>3) Sealing hypersensitive<br>areas | 1) Anterior restorations<br>(Class III, IV)<br>2) Class V restorations<br>3) Restorations in the<br>posterior region(Class I, II)<br>4) Veneering of discolored<br>anterior teeth<br>5) Splinting of mobile teeth<br>6) Repair of composite and<br>ceramic veneers. | 1) Restoration of class I-V<br>cavities.<br>2) Restoration of root surface<br>caries.<br>3) Restoration of deciduous<br>teeth.<br>4) Filling tunnel shaped<br>cavities.<br>5) Sealing hypersensitive areas<br>6) Liner/base/filling in cavity<br>undercuts<br>7) Sealant<br>8) Splinting mobile teeth<br>9) Additions to composite<br>restorations. | 1) Class V restorations<br>2) Anterior<br>restorations(Class III,IV)<br>3) Small posterior<br>restorations<br>4) Restorative therapy for<br>mini-cavities of all types.<br>5) Extended fissures sealing<br>in molars and premolars.<br>6) Repair of<br>composite/ceramic veneers.<br>7) Blocking out of<br>undercuts |
| Material<br>Composition | Barium Glass, Urethane<br>Dimethacrylate(UDMA),<br>Triethylene Glycol<br>Dimethacrylate(TEGDMA)<br>, Bis-GMA, etc | Barium Glass,<br>Dimethacrylates(UDMA), etc | Triethylene Glycol<br>Dimethacrylate(TEGDMA),<br>Urethane<br>Dimethacrylate(UDMA), etc | Bis-GMA, Barium<br>aluminosilicate.<br>Triethylene Glycol<br>Dimethacrylate(TEGDMA,<br>etc |
| Human Factors | Ready to use dispensing<br>system | Ready to use dispensing<br>system | Ready to use dispensing<br>system | Ready to use dispensing<br>system |
| Biocompatibili | Biocompatible, conforming | Biocompatible, conforming to | Biocompatible, conforming to | Biocompatible, conforming |
| ty | to ISO 10993 | ISO 10993 | ISO 10993 | to ISO 10993 |
| Physical<br>Properties | Meets ISO 4049<br>specifications | Meets ISO 4049 specifications | Meets ISO 4049 specifications | Meets ISO 4049<br>specifications |

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#### 9. Conclusion:

Based on the testing results, KM Corporation concludes that the Enaden Flow is substantially equivalent to the predicate devices.

·

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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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 [phone] or [phone] 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K140976

Device Name Enaden Flow

Indications for Use (Describe) The Enaden Flow is intended for use in :

1) Restoration of class I~V cavities

2) Blocking out of undercuts

3) 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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