MULTIPLE RESIN TOOTH BONDING AGENT

K052501 · Cosmedent, Inc. · KLE · Oct 21, 2005 · Dental

Device Facts

• Record ID: K052501
• Device Name: MULTIPLE RESIN TOOTH BONDING AGENT
• Applicant: Cosmedent, Inc.
• Product Code: KLE · Dental
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Resin Tooth Bonding Agent is used to facilitate the adhesive bonding of restorative/preventive dental materials to dental hard tissues as well as to other restorative materials.

Device Story

Cosmedent Resin Tooth Bonding Agent is a dual-cure 4th generation dentin/enamel adhesive. It consists of two bottles, Primer A and Primer B. Primer A can be used alone and light-cured, or mixed with Primer B for self-curing. Two coats are applied to prepared teeth. The device promotes adhesion of resin composite restoratives to dental hard tissues. It is used in a clinical setting by dental professionals. The adhesive bond strength is approximately 25 MPa. The device benefits patients by providing a reliable interface between restorative materials and tooth structure.

Clinical Evidence

Bench testing only. The device demonstrates an adhesive bond strength of approximately 25 MPa, compared to 28 MPa for the predicate device.

Technological Characteristics

Dual-cure 4th generation resin bonding agent; acetone-based solution of room temperature polymerizing dimethacrylates. Kit components include resin adhesive, phosphoric acid etchant, and silane coupling agent. Applied in two coats.

Indications for Use

Indicated for use by dental professionals to facilitate adhesive bonding of restorative or preventive dental materials to dentin, enamel, and other restorative materials.

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

• Bisco All-Bond 2 (K910860)

Submission Summary (Full Text)

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

K05250|

Page 19 of 21

Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for RESIN TOOTH BONDING AGENT

3CT 2 1 2005

#### 510(k) SUMMARY As required by the Safe Medical Devices Act of 1990

### DESCRIPTION OF THE APPLICANT DEVICE

TRADE NAME: Multiple COMMON NAME: Dentin/enamel adhesive CLASSIFICATION NAME: Tooth resin bonding agent (21 CFR 872.3200, Product code KLE)

Cosmedent Resin Tooth Bonding Agent is a dual-cure 4th generation resin tooth bonding agent based on an acetone solution of room temperature polymerizing dimethacrylates. The device consists of two bottles designated as Primer A and Primer B. Primer A can be used alone and light cured, or it can be mixed with Primer B whereupon the adhesive will self cure in a clinically appropriate amount of time. In either case, two coats of the adhesive are applied to the prepared teeth. The adhesive bond strength of the device is approximately 25 MPa. The product is intended to be used to promote the adhesion of resin composite restoratives to dentin and enamel.

The technological characteristics of the applicant device are identical to the predicate device except with the latter; equal quantities of A and B are mixed and cured whereas with the former, A can be cured alone or mixed with B and allowed to self cure. The safety and efficacy are otherwise equivalent.

### IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

Bisco All-Bond 2 (K910860) is a dual-cure 4th generation resin tooth bonding agent based on an acetone solution of room temperature polymerizing dimethacrylates. Primers A and B are mixed and five coats of the mixed material are applied to the prepared teeth. The adhesive will self cure in a clinically appropriate amount of time, or the mixed adhesive can be light cured. The adhesive bond strength of the device is approximately 28 MPa. The product is intended to be used to promote the adhesion of resin composite restoratives to dentin and enamel.

Omer L. Sandlin

James L. Sandrik, PhD

Cosmedent, Inc. 401 N. Michigan Avenue Suite 2500 Chicago, Illinois 60611 Phone: [phone] Fax: [phone] [e-mail] Submitted: September 8, 2005

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Public Health Service

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James L. Sandrik, PhD Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611

Re: K052501

Trade/Device Name: Resin Tooth Bonding Agent Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 08, 2005 Received: September 13, 2005

Dear Dr. Sandrik:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your becasing in (t) for the is substantially equivalent (for the indications for relered above and nave acterimined marketed predicate devices marketed in interstate commerce use stated in the encreasure) to regain that of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic ilave bech receasified in acceration of a premarket approval application (PMA). You may, Act (Act) market the device, subject to the general controls provisions of the Act. The general therefore, market the device, backed we annual registration, listing of devices, good controls provibitions and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice to such additional controls. Existing major regulations affecting your device can be illay be subject to such additional controls. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

# Page 2 -- James L. Sandrik, PhD

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issuance of a substance oner requirements of the Act or
that FDA has made a determination that your device complies with must comply with that FDA has made a determination that your uce also encess. You must comply with any Federal statutes and regulations administered by oner restation and listing (21 CFF Part 807);
all the Act's requirements, including, but not limited to: restaurants as e all the Act's requirements, including but normance requirements as set forth in the quality
labeling (21 CFR Part 801); good names as an and contropic product radiation labeling (21 CFR Part 801); good manufacturing passicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produ systems (QS) regulation (21 G31-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin maketing your active as easence of your device to a legally
premarket notification. The FDA finding of substantial equiralsed thus, nermi premarket notification. The FDA Inding of substantal equivaliation of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs of the may of the support of 2115 - Also and association entitled If you desire specific advice for your uc-vice on our in and have note the regulation entitled, the regulation entitled, the contact the Office of Compliance and 240, 210-011-17 (12. CFR Pat 807.97). You may obtain other
"Misbranding by reference to prematics notification it a frem the Division of "Misbranding by reference to premailities under the Act from the Division of Small
general information on your responsibilities under the Act its toll free number (800) 6 general intormation on your responsibilities and its toll-free number [phone] or 1 Manufacturers, Internet and Consulter / Essibance at to vol. #10 votes #10 votes #110 l.
[phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/in

Sincerely yours,

Smute. Y. Michie Oms

Chiú S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page 6 of 21

# INDICATIONS FOR USE

510(k) Number (if known):

K052501

Device Name: MULTIPLE (RESIN TOOTH BONDING AGENT)

Indications For Use:

Resin Tooth Bonding Agent is used to facilitate the adhesive bonding of restorative/preventive dental materials to dental hard tissues as well as to other restorative materials.

Resin Tooth Bonding Agent is marketed as a kit that may contain:

- A single light-cure resin component .
- A two-component self-cure resin adhesive .
- A phosphoric acid etchant .
- A silane coupling agent .

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sonser Rumm

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

510(k) Number: K052550