WELL-PASTE

K090992 · Vericom Co., Ltd. · KIF · Apr 21, 2009 · Dental

Device Facts

• Record ID: K090992
• Device Name: WELL-PASTE
• Applicant: Vericom Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Apr 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

Well-Paste™ is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Well-Paste™ can be used on its own and for vital pulpectomies in deciduous teeth.

Device Story

Well-Paste™ is a premixed, non-setting root canal filling material containing Calcium Hydroxide and Barium Sulfate. It is supplied in a syringe with disposable tips for application. The device is used by dental professionals in a clinical setting to provide temporary filling after endodontic procedures or for pulpectomies in deciduous teeth. Its high fluidity and radiopacity facilitate placement and visualization within the root canal. The material remains stable without solidification or separation, providing a biocompatible seal.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility, safety, and performance validation (flow, film thickness, radiopacity, solubility, and disintegration).

Technological Characteristics

Premixed, non-setting paste containing Calcium Hydroxide and Barium Sulfate. Delivered via syringe with disposable tips. Features high fluidity and radiopacity. Class II device (Product Code: KIF).

Indications for Use

Indicated for temporary root canal filling following endodontic surgery, use as a standalone sealer, and for vital pulpectomies in deciduous teeth.

Regulatory Classification

Identification

A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.

Predicate Devices

• Metapaste, META BIOMED CO. LTD. (K032605)

Submission Summary (Full Text)

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Vericom Co. Ltd.

Healthy and beautiful teeth with Vericom

510(k) Summary

Kogomd

APR 2.1 2009

000018

Page 1 of 2

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

Date: December 1, 2008

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 - Well-Paste TM Common Name - Root canal filling Materials Classification Name - Resin, Root Canal Filling

- 3. Predicate Device : Metapaste, META BIOMED CO. LTD. K032605
- 4. Description :

Well-Paste™ is a temporary root canal filling material after endodontic surgery as pulp capping, pulpotomy or apexification. It contains Calcium Hydroxide and Barium Sulfate mainly, so it shows excellent radiopacity. It also has high fluidity and excellent accessibility into the root canal. Well-Paste™ is premixed paste as a non-setting material and is very stable without any solidification or separation. And it is packaged in a convenient syringe with disposable tips, a plastic holder and disposable tip cap.

- 5. Indication for use :
Well-Paste™ is a biocompatible root canal sealer used for the temporary filling of root canal after endodontic surgery. Well-Paste™ can be used on its own and for vital pulpectornies in deciduous teeth.

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

September 1998 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 199

Image /page/0/Picture/18 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in bold, sans-serif font, arched upwards. Below the word, in a smaller font, are the words "Dental materials."

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### 6. Review :

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

Well-Paste™ has the similar physical properties as the predicate device; flow, film thickness, radiopacity, solubility and disintegration.

Well-Paste™ 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 Well-Paste™ 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 seasonably necessary by the FDA.
END

# 606,5th 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 for a company that produces dental materials. The logo consists of the word "VERICOM" in bold, white letters on a black, curved background. Below the word "VERICOM" is the phrase "Dental materials" in a smaller, sans-serif font. The logo is simple and professional, and it clearly communicates the company's focus on dental products.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2009

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

Re: K090992

Trade/Device Name: Well-Paste™ Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: March 12, 2009 Received: April 7, 2009

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.

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Suarez

Susan Runner, D.D.S., MA Acting 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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000017

510(k) Number K

Device Name: Well-Paste™

Indication for use:

Well-Paste™ is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Well-Paste™ can be used on its own and for vital pulpectomies in deciduous teeth.

Prescription Use OR (Per 21CFR801.109)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Susan Turner

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

-10(k) Number: K080991

Vericom Co., Ltd.

4. Indication for use Page # 1 of 1