ECO-S

K103121 · Vericom Co., Ltd. · EBC · Oct 26, 2010 · Dental

Device Facts

• Record ID: K103121
• Device Name: ECO-S
• Applicant: Vericom Co., Ltd.
• Product Code: EBC · Dental
• Decision Date: Oct 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Pit and fissure sealant

Device Story

Eco-S is a single-part, light-curing dental sealant based on methacrylate resin chemistry. It is applied to the pits and fissures of posterior teeth to act as a sealant. The device is used in a dental clinic setting by a dental professional. It is not a permanent restoration. The sealant is cured using a light-curing unit, which hardens the material to provide a protective barrier on the tooth surface.

Clinical Evidence

Bench testing only. Safety and performance validations were performed, including biocompatibility testing, to ensure compliance with applicable international and US regulations.

Technological Characteristics

Single-part, light-curing pit and fissure sealant based on methacrylate resin chemistry. Physical properties include shear bond strength, ambient light sensitivity, cure time, depth of cure, and uncured film thickness.

Indications for Use

Indicated for use as a pit and fissure sealant on posterior teeth.

Regulatory Classification

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.

Predicate Devices

• 3M Clinpro™ Sealant (K992326)

Submission Summary (Full Text)

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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

1. Company making the submission:

| | Submitter |
|----------|----------------------------------------------------------------------------------------------------------------------------|
| Name | VERICOM Co., Ltd. |
| Address | #606, 5th Dongyoung Venturestel<br>199-32, Anyang 7-Dong, Manan-Gu<br>Anyang-Si, Gyeonggi-Do,<br>Republic of Korea 430-817 |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Myung-Hwan Oh |
| Internet | [e-mail] |

## 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

- 4. 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.

- 5. 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

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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

6. Review :

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

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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.

- 7. 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.

8. 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 [phone] or [phone] 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™ |
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| 510(k) Number K | KG3121 | | OCT 2 6 2010 |
| Device Name: Eco-S™ | | | |
| Indication for use: | | | |
| | Pit and fissure sealant | | |
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| Prescription Use | | OR | Over-The-Counter Use |
| (Per 21CFR801.109) | | | |
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| (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.

4. Indication for use Page # 1 of 1

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