DENFIL ETCHANT-37

K080265 · Vericom Co., Ltd. · EBF · Feb 6, 2008 · Dental

Device Facts

• Record ID: K080265
• Device Name: DENFIL ETCHANT-37
• Applicant: Vericom Co., Ltd.
• Product Code: EBF · Dental
• Decision Date: Feb 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Etching the enamel and dentine for adhesive restorations.

Device Story

DenFil™ Etchant-37 is a dental etching agent composed of 37% phosphoric acid thickened with natural polymer. It is applied by a clinician to the interior of a prepared tooth cavity to etch enamel and dentine surfaces. This process increases surface roughness to improve the retention of subsequent adhesive restorative materials. The device is used in a dental clinic setting by dental professionals.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance were established through comparative testing of chemical composition, pH, adhesion, and viscosity against the predicate device, alongside biocompatibility testing.

Technological Characteristics

37% phosphoric acid formulation thickened with natural polymer. Formulated as a gel for topical application to tooth structure. Classified as a tooth shade resin material (21 CFR 872.3690).

Indications for Use

Indicated for etching enamel and dentine to improve retention of adhesive dental restorations.

Regulatory Classification

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.

Predicate Devices

• K-ETCHANT GEL (K062409)

Submission Summary (Full Text)

{0}------------------------------------------------

Ko80265

### 000015

2007 2008

Vericom Co. Ltd.

Healthy and beautiful teeth with Vericom

Page 1 of 2

## 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: September 1, 2007

1. Company making the submission:

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

2, Device:

Proprietary Name - DenFil™ Etchant-37 Common Name - Etching agent Classification Name - Material, Tooth Shade, Resin

3. Predicate Device:

K-ETCHANT GEL, KURARAY MEDICAL INC, K062409

#### 4. Description:

DenFil™ Etchant-37 is an etching agent consists of 37% phosphoric acid formulations
thickened with natural polymer. It is classified into tooth shade resin material, 21 CFFR Section 872.3690, because it is a device intended to be painted on the interior of a
prepared cavity of a tooth to improve retention of a restoration.

5. Indication for use:

Etching the enamel and dentine for adhesive restorations.

に、そのあると、そのため、このと、この、ここで、

# 606,50 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 a logo for Vericom Dental Materials. The logo is black and white and features the word "VERICOM" in a stylized font. Below the word "VERICOM" are the words "Dental materials" in a smaller font. The logo is simple and professional, and it is likely used to promote Vericom Dental Materials and its products.

{1}------------------------------------------------

## 000016

Page 2 of 2

Vericom Co. Ltd. Company Comments of Children Comments of

Healthy and beautiful teeth with Vericom

### 6. Review:

DenFil™ Etchant-37 has the same device characteristics as the predicate device; main material, chemical composition, and use concept.

DenFil™ Etchant-37 has the similar mechanical properties as the predicate device; pH, adhesion and viscosity.

DenFil™ Etchant-37 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 Internation 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 DenFam Etchant-37 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

CI Car 2019 Catalia 2011 - 14

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

Image /page/1/Picture/14 description: The image shows a logo for a company called "VERICOM Dental materials". The logo is in black and white and features the company name in a stylized font. The words "Dental materials" are written in a smaller font below the company name. The logo has a curved shape.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of thick, black lines.

FEB - 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vericom Company, Limited C/O Mr. Morten S. Christensen Responsible Third Party Official Underwriters Laboratories Incorporated 455 East Trimble Road San Jose, California 95131-1230

Re: K080265

Trade/Device Name: DenFil™ Etchant-37 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 22, 2008 Received: February 1, 2008

Dear Mr. Christensen:

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.

{3}------------------------------------------------

Page 2 - Mr. Christensen

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office 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 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,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# 000011

510(k) Submission - DenFill™ Etchant-37

510(k) Number K080305

Device Name: DenFil™ Etchant-37

Indication for use:

Etching the enamel and dentine for adhesive restorations. .

Prescription Use (Per 21CFR801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vericom Co., Ltd.

Susan Ruoves

Division Sign-Off)

Jivision of Anesthesists

4. Indication for use Page # 1 of 1

Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices

10(k) Number: TO 800