BC PLUS

K043562 · Vericom Co., Ltd. · KLE · Jan 3, 2005 · Dental

Device Facts

• Record ID: K043562
• Device Name: BC PLUS
• Applicant: Vericom Co., Ltd.
• Product Code: KLE · Dental
• Decision Date: Jan 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

BC Plus™ is a light curing single component bonding agent specially developed as a restorative adhesive in dentistry, which is used for bonding resin-based filling materials (e.g. composites, compomers) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. BC Plus™ permits priming and bonding to be carried out in single step.

Device Story

BC Plus™ is a light-activated, ethanol-based, single-component resin bonding agent used in restorative dentistry. It functions as an adhesive to bond resin-based filling materials (composites, compomers), amalgam, and laboratory-produced restorations to hard dental tissues. The device is applied by a dental professional in a clinical setting. It simplifies the restorative process by allowing priming and bonding to occur in a single step. The agent is cured using a dental light source. By providing a reliable bond between restorative materials and tooth structure, it aids in the retention and sealing of dental restorations, potentially improving clinical outcomes and restoration longevity.

Clinical Evidence

No clinical data. Safety and performance were established through bench testing, product validation, and a review of literature pertaining to the safety and biocompatibility of resin tooth bonding agents.

Technological Characteristics

Single-component, light-activated, ethanol-based adhesive resin. Designed for bonding composites, compomers, amalgam, and laboratory restorations to dental tissues. Class II device (21 CFR 872.3200).

Indications for Use

Indicated for use as a restorative adhesive in dentistry for bonding resin-based filling materials (composites, compomers) to hard dental tissues, as well as bonding amalgam and laboratory-produced restorations. Contraindicated in patients with hypersensitivity to the agent or methacrylate monomers.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• Kaazaas

Submission Summary (Full Text)

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K043562

Page 1 of 2

0011

Vericom Co. Ltd.

Healthy and beautiful teeth with Vericom

## 510(k) Summary

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

Date: Nov.24, 2004

- 1. Company and Correspondent making the submission:

| | Company |
|----------|----------------------------------------------------------------------------------------------------------------------------|
| 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 - BC Plus™ Common Name - Resin Tooth Bonding Agent Classification Name - Agent, Tooth Bonding, Resin 21CFR 872.3200, KLE, Class2

3. Predicate Device :
Kaazaas

- 4. Description :
BC Plus™ is a single component bonding agent designed to bond composite to dentin, enamel, cast metals, treated porcelain and set amalgam. BC Plus™ is an ethanol based formulation of light-activated, adhesive resin.

- 5. Indication for use :
BC Plus™ is a light curing single component bonding agent use in restorative adhesive dentistry specifically developed for bonding resin-based filling materials (e.g. composites, compomers) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. BC Plus™ permits priming and bonding to be carried out in single step.

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

Image /page/0/Picture/19 description: The image shows the logo for Vericom Dental Materials. The logo is a black curved shape with the word "VERICOM" in white letters inside. Below the curved shape, the words "Dental materials" are written in a smaller font.

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Page 2 of 2

Healthy and beautiful teeth with Vericom

- 6. Contra-indications :
BC Plus™ should not be used with patients who develop hypersensitivity to it or have a history of hypersensitivity to methacrylate monomer.

1 - .

- 7. Review :
BC Plus™ has the same device characteristics as the predicate device. Material, design and use concept is similar.

BC Plus™ has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.

An extensive review of literature pertaining to the safety and biocompatibility of resin tooth bonding agent has been conducted. Appropriate safeguards have been incorporated in the design of BC Plus™

- 8. Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's "Guidance for the Preparation of Premarket notifications for Dental Composite" and based on the information provided in this premarket notification Vericom Co., Ltd. concludes that BC Plus™ is safe and effective and substantially equivalent to predicate devices as described herein. ﺎ

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

r :

Image /page/1/Picture/15 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in a stylized, curved font, positioned above the words "Dental materials" in a smaller, simpler font. The logo is black and white.

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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" written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing shapes. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 3 2005

Vericom Company Limited C/O Mr. Chan Yo Won Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542

Re: K043562

Trade/Device Name: BC Plus™ Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: December 3, 2004 Received: December 27, 2004

Dear Mr. Won:

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 such 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. Won

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 mean that 1 27 mas muss statutes and regulations administered by other Federal agencies. or the rive of any I vath all the Act's requirements, including, but not limited to: registration r od inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT art 007), aquality systems (QS) regulation (21 CFR Part 820); and if requirelate as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo leter notification. The FDA finding of substantial equivalence of your device to a premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desite specifical of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overnit Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Quite y. Mchiee m.D.

Chiu Lin. Ph.D. Director

DR. CHILL LIN

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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510(k) Number K 0 4 3562

Device Name: BC Plus™

Indication for use:

BC Plus™ is a light curing single component bonding agent specially developed as a restorative adhesive in dentistry, which is used for bonding resin-based filling materials (e.g. composites, compomers) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. BC Plus™ permits priming and bonding to be carried out in single step.

Over-The-Counter Use OR Prescription 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)

MEad, the MSR

(Civision Sigh-Off) Division of Anesthesiology, General Hospital,
Intection of Anesthesiology, General Hospital, Intection of Anesthesiology, Intection Control, De

:10(k) Number: K043562