Eco-S™ is a single part, light curing, pit and fissure sealant. It is based on methacrylate resin chemistry. It can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.

AI/ML Overview

The provided text describes a 510(k) summary for a dental sealant called "Eco-S™". It makes claims of substantial equivalence to a predicate device (3M Clinpro™ Sealant, K992326) based on similar technological characteristics and physical properties. However, the document does not describe acceptance criteria or a study that rigorously proves the device meets specific performance metrics in a clinical or standalone study context.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Technological Characteristics: Similar device design, appearance, main materials, and indication for use as predicate device (3M Clinpro™ Sealant, K992326).	Eco-S™ has similar technological characteristics (device design, appearance, main materials, indication for use) as the predicate device.
Physical Properties: Similar shear bond strength, ambient light sensitivity, cure time, depth of cure, and uncured film thickness as predicate device.	Eco-S™ has similar physical properties (shear bond strength, ambient light sensitivity, cure time, depth of cure, uncured film thickness) as the predicate device.
Safety: Biocompatibility and compliance with applicable International and US regulations.	Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

Important Note: The document frames "acceptance criteria" as similarity to a predicate device rather than specific quantitative thresholds for performance.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for a test set or data provenance because it primarily relies on demonstrating similarity to a predicate device through physical and technological characteristics. There is no mention of clinical data or a test set in the traditional sense for evaluating AI or diagnostic device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as there is no test set or mention of expert-established ground truth for evaluating the device's performance against clinical outcomes or diagnoses. The evaluation relies on comparing physical and technological properties to a predicate device.

4. Adjudication method for the test set

This information is not applicable as there is no test set or clinical study described that would require an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a pit and fissure sealant, a dental material, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic or AI devices is not directly relevant here. The "ground truth" for this device's acceptance is based on its physical and technological similarity to a legally marketed predicate device (3M Clinpro™ Sealant, K992326) and compliance with safety regulations (biocompatibility).

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm and therefore does not have a training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI algorithm and therefore does not have a training set.

Summary of the Study/Evaluation described:

The document describes a Predicate Device Comparison as the primary method to demonstrate safety and effectiveness.

Study Design: The submission asserts that Eco-S™ has "similar technological characteristics" and "similar physical properties" to the predicate device (3M Clinpro™ Sealant, K992326).
Performance Metrics Compared: Device design, appearance, main materials, indication for use, shear bond strength, ambient light sensitivity, cure time, depth of cure, and uncured film thickness.
Safety Evaluation: Biocompatibility tests were performed, and the device is stated to comply with applicable International and US regulations.

The study presented is not a traditional clinical trial or an evaluation of an AI algorithm's performance. Instead, it's a demonstration of substantial equivalence through comparison of material properties and characteristics to a previously approved device.

Summary

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000017

Page 1 of 2

Vericom Co. Ltd.

Healthy and beautiful teeth with Vericom

510(k) Summary

y K103R1

OCT 2 6 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: August 20, 2010

Company making the submission:

	Submitter
Name	VERICOM Co., Ltd.
Address	#606, 5th Dongyoung Venturestel199-32, Anyang 7-Dong, Manan-GuAnyang-Si, Gyeonggi-Do,Republic of Korea 430-817
Phone	+82 31 441-2881
Fax	+82 31 441-2883
Contact	Myung-Hwan Oh
Internet	mh-oh@hanmail.net

2. Device :

Proprietary Name - Eco-S TM Common Name - Dental sealant, pit and fissure sealant Classification Name - Sealant, Pit And Fissure, And Conditioner

3 .- Predicate Device .-

3M Clinpro™ Sealant, 3M COMPANY, K992326

1. Description :
  Eco-S™ is a single part, light curing, pit and fissure sealant. It is based on methacrylate resin chemistry. It can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.
1. Indication for use :
  Pit and fissure sealant

606,5th Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea

ているので、その他のお気になることになるというというというという

Image /page/0/Picture/19 description: The image shows the logo for Vericom Dental Materials. The logo features the word "VERICOM" in bold, stylized letters, arched in a crescent shape. Below the word, in a smaller font, are the words "Dental materials."

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Vericom Co. Ltd.

CHUCK STATE - ----------------------------------------------------------------------------------------------------------------------------------------------------------------

Healthy and beautiful teeth with Vericom

Review :

Eco-S ™ has the similar technological characteristics as the predicate device; device design, appearance, main materials and indication for use.

2 .. .........................................................................................................................................................................

ースーム Mark Times Times Corpora

Eco-S TM has the similar physical properties as the predicate device; Shear bond strength, Ambient light sensitivity. Cure time, Depth of cure and Uncured film thickness.

Eco-S ™ has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

1. Conclusions :
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Vericom Co., Ltd. concludes that Eco-S TM is safe and effective and substantially equivalent to predicate devices as described herein.

Vericom Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.

END

606,5 Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea

Image /page/1/Picture/12 description: The image shows a logo with the word "VERICOM" in bold, white letters against a black background. The logo is curved, with the word "VERICOM" in the center. The logo has a crescent shape. The letters are evenly spaced and easy to read.

Dental materials

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vericom Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526

OCT 2 6 2010

Re: K103121

Trade/Device Name: Eco-STM Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: October 3, 2010 Received: October 22, 2010

Dear Mr. Mouser:

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 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.

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Page 2- Mr. Mouser

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 (QS) 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.gov/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.

Susan Lunnes

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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			000016 510(k) Submission - Eco-S™
510(k) Number K	KG3121		OCT 2 6 2010
Device Name: Eco-S™
Indication for use:
	Pit and fissure sealant







Prescription Use		OR	Over-The-Counter Use
(Per 21CFR801.109)



(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
	Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
	510(k) Number:	KG3121

Vericom Co., Ltd.

Indication for use Page # 1 of 1

l rt

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.