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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Enaden Flow device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for Enaden Flow (K140976)

1. Table of Acceptance Criteria and Reported Device Performance

The application states that the device was tested based on referenced standards and that "All the test results support substantial equivalence to the predicate devices." This implies that the acceptance criteria for each tested property were to meet or exceed the performance of the predicate devices or to conform to the specified ISO standards. The direct acceptance criteria values are not explicitly specified in numerical terms in this summary, but rather implied by adherence to standards and substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Meets ISO 4049 (Flexural Strength, Sensitivity to Ambient Light, Depth of polymerization, Water Absorption/Solubility, Radio-opacity, Color/Color Stability) specifications	Meets ISO 4049 specifications (as per table)
Meets ISO 9917 (Compressive Strength) specifications	(Implied by overall "Meets ISO 4049 specifications")
Conforms to ISO 10993-5 (Cytotoxicity)	Biocompatible, conforming to ISO 10993 (as per table)
Conforms to ISO 10993-10 (Skin sensitization test, Oral mucous irritation test)	Biocompatible, conforming to ISO 10993 (as per table)
Conforms to ISO 10993-11 (Short term systemic toxicity test)	Biocompatible, conforming to ISO 10993 (as per table)
Meets specifications for other bench testing (Shelf life, Appearance, Volume, and Packaging tests)	(Implied by overall "substantially equivalent")

Note: The summary states that "The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices." This means that the device was evaluated against the performance of the existing predicate devices (Tetric Evocream, G-aenial Universal Flo, Denfil Flow) for these properties, and found to be comparable or better.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary provides details on non-clinical performance data (bench testing) but does not specify sample sizes for these tests.
The data provenance is from bench testing and not human clinical data. Therefore, notions of country of origin or retrospective/prospective do not apply in the typical sense for clinical studies. The tests were performed by the manufacturer, KM Corporation, based in the Republic of Korea.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission relies on non-clinical (bench) testing. There were no human readers or experts establishing ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical bench testing, there is no test set in the context of human data requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a submission for a dental restorative material, which does not involve human readers interpreting images, and therefore does not assess the effect of AI on human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical dental restorative material, not a software algorithm. Therefore, "standalone performance" in the context of algorithm-only performance is not relevant. The performance data provided relates to the physical and biocompatible properties of the material itself.

7. The Type of Ground Truth Used

The ground truth for the performance claims is based on established international standards (ISO 4049, ISO 9917, ISO 10993) and comparison to legally marketed predicate devices. The "ground truth" is the established performance benchmarks set by these standards and the observed performance of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device (restorative material) and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The device itself is manufactured to specifications, and its properties are tested to demonstrate compliance and substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device. The quality and performance of the device are ensured through manufacturing controls and adherence to material specifications and testing against established standards.

Summary

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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: +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:

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)

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Device Description: 5.

6. Intended Use:

The Enaden Flow is intended for use in:

1. Restoration of class I~V cavities
1. Blocking out of undercuts
1. 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)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 isintended for use in :1) Restoration of class I~Vcavities.2) Blocking out ofundercuts.3) Sealing hypersensitiveareas	1) Anterior restorations(Class III, IV)2) Class V restorations3) Restorations in theposterior region(Class I, II)4) Veneering of discoloredanterior teeth5) Splinting of mobile teeth6) Repair of composite andceramic veneers.	1) Restoration of class I-Vcavities.2) Restoration of root surfacecaries.3) Restoration of deciduousteeth.4) Filling tunnel shapedcavities.5) Sealing hypersensitive areas6) Liner/base/filling in cavityundercuts7) Sealant8) Splinting mobile teeth9) Additions to compositerestorations.	1) Class V restorations2) Anteriorrestorations(Class III,IV)3) Small posteriorrestorations4) Restorative therapy formini-cavities of all types.5) Extended fissures sealingin molars and premolars.6) Repair ofcomposite/ceramic veneers.7) Blocking out ofundercuts
MaterialComposition	Barium Glass, UrethaneDimethacrylate(UDMA),Triethylene GlycolDimethacrylate(TEGDMA), Bis-GMA, etc	Barium Glass,Dimethacrylates(UDMA), etc	Triethylene GlycolDimethacrylate(TEGDMA),UrethaneDimethacrylate(UDMA), etc	Bis-GMA, Bariumaluminosilicate.Triethylene GlycolDimethacrylate(TEGDMA,etc
Human Factors	Ready to use dispensingsystem	Ready to use dispensingsystem	Ready to use dispensingsystem	Ready to use dispensingsystem
Biocompatibili	Biocompatible, conforming	Biocompatible, conforming to	Biocompatible, conforming to	Biocompatible, conforming
ty	to ISO 10993	ISO 10993	ISO 10993	to ISO 10993
PhysicalProperties	Meets ISO 4049specifications	Meets ISO 4049 specifications	Meets ISO 4049 specifications	Meets ISO 4049specifications

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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 (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

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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 :

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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Regulation Number and Section

§ 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.