RELIANCE S.E.P.

K071688 · Reliance Orthodontic Products, Inc. · KLE · Sep 7, 2007 · Dental

Device Facts

• Record ID: K071688
• Device Name: RELIANCE S.E.P.
• Applicant: Reliance Orthodontic Products, Inc.
• Product Code: KLE · Dental
• Decision Date: Sep 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Reliance S.E.P. is a one step self etching primer intended to be used for the preparation of a tooth surface prior to bonding an orthodontic appliance(s) with a light cure adhesive.

Device Story

Reliance S.E.P. is a one-step self-etching primer for orthodontic bonding. Device consists of a handheld dispenser containing the primer solution; manual compression dispenses solution into a light-impervious mixing well. Used by orthodontists or dental professionals in a clinical setting to prepare enamel surfaces before applying light-cure adhesives. The primer combines etching and priming into a single step, simplifying the bonding process. Clinical benefit includes effective bond strength for orthodontic appliances, facilitating treatment for patients ranging from pediatric to adult.

Clinical Evidence

Bench testing only. Comparative shear bond strength testing performed against the predicate device demonstrated equivalent effectiveness. Oral toxicity testing confirmed the device is non-toxic.

Technological Characteristics

One-step self-etching primer; chemical composition includes acidic monomer and solvent. Delivered via handheld dispenser into a light-impervious mixing well. Designed for use with light-cure orthodontic adhesives.

Indications for Use

Indicated for preparation of tooth surfaces prior to bonding orthodontic appliances with light cure adhesives in pediatric to adult patients.

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

• 3M Unitek Transbond ™ Plus Self Etching Primer (K984246)

Submission Summary (Full Text)

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Reliance Orthodontic Products, Inc.

K071688

Toll Free 1-800-323-4348 · Phone [phone] · Fax [phone] PO Box 678 · Itasca, IL · 60143 · U.S.A.

SEP - 7 2007

### Section 5.0 510 (k) Summary

Note: This summary is provided in accordance with the requirements of 21CFR807.92 (c).

| 510 (k) Owners Name: | Reliance Orthodontic Products, Inc.<br>Paul Gange, President | |
|----------------------|--------------------------------------------------------------|--|
| Address: | 1540 West Thorndale Avenue<br>Itasca, Il 60143 USA | |
| Phone Number: | 630-773-4009 | |
| Fax Number: | 630-250-7704 | |
| Contact Person: | Paula Wendland, Regulatory Affairs Manager<br>(Preparer) | |

Date 510 (k) Summary was Prepared: June 14, 2007

Medical Device Name:

- Trade name Reliance S.E.P. .
- Common name Self Etching Primer .
- Classification name Resin Tooth Bonding Agent (21CFR872.3200, . Product Code KLE, Class II Device)

# LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]:

- 3M Unitek Transbond ™ Plus Self Etching Primer (510(k) submission . K984246 under the ESPE Dental Ag Prompt L-Pop)

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Image /page/1/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo consists of a stylized letter "R" enclosed in a circle, which is positioned above the company name. The company name is written in a cursive font, with the words "Reliance Orthodontic Products" on the first line and "Inc." on the second line. The logo is simple and elegant, and it conveys a sense of professionalism and quality.

Toll Free 1-800-323-4348 · Phone [phone] · Fax [phone] PO Box 678 · Itasca, IL · 60143 · U.S.A

# DESCRIPTION OF THE APPLICANTS DEVICE:

The Reliance S.E.P. is a one step self etching primer contained in a handheld dispenser. Upon manual compression into a light impervious mixing well, enough solution is dispensed to prepare the enamel surface of up to 20 teeth.

## INTENDED USE AND POPULATION:

The Reliance S.E.P. is a one step self etching primer intended to be used for the preparation of a tooth surface prior to bonding an orthodontic appliance(s) with a light cure adhesive. The intended patient population ranges from pediatric to adult recipients of orthodontic treatment.

TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:

Performance Characteristics of the Reliance S.E.P. versus the 3M Unitek Transbond ™ Plus Self Etching Primer:

| Property | Reliance S.E.P. | 3M Unitek Transbond™<br>Plus Self Etching<br>Primer |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Intended Use | Self Etching Primer,<br>Single Step Delivery for<br>use with light cure<br>bonding orthodontic<br>adhesives | Self Etching Primer,<br>Single Step Delivery<br>use with light cure<br>bonding orthodontic<br>adhesives. |
| Mechanical / Physical<br>Properties | • Combines etching<br>and priming in one<br>easy step<br>• Effective bond<br>strength | • Combines etching<br>and priming in one<br>easy step<br>• Effective bond<br>strength |
| Chemical Composition | Acidic Monomer /<br>Solvent | Acidic Monomer /<br>Solvent |

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Image /page/2/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a stylized "R" enclosed in a circle, which is positioned above the company name. The company name is written in an elegant, cursive font. The words "Reliance Orthodontic Products, Inc." are all on one line.

Toll Free 1-800-323-4348 · Phone [phone] · Fax [phone] PO Box 678 - Itasca, IL - 60143 · U.S.A.

Shear bond strength testing comparisons conducted between the Reliance S.E.P. and the predicate device, 3M Unitek Transbond TM Plus Self Etching Primer demonstrate that the applicant device is equivalent to the legally marketed device in terms of effectiveness.

Additionally, toxicity testing was conducted using an Oral Toxicity Test method and was found to be non toxic. Sufficient data has been generated to demonstrate that the applicant device is safe for its intended use.

Paula Wendland Regulatory Affairs Manager Reliance Orthodontic Products, Inc. 800-323-4348 / 630-773-4009 Fax: [phone]

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

SEP - 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Paula Wendland Regulatory Affairs Manager Reliance Orthodontic Products, Incorporated 1540 West Thorndale Avenue Itasca, Illinois 60143

Re: K071688

Trade/Device Name: Reliance S.E.P. Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 24, 2007 Received: August 27, 2007

Dear Ms. Wendland:

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 - Ms. Wendland

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 vours.

Spirite y. Mckinno md

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

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Image /page/5/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a stylized "R" inside a circle with a registered trademark symbol. Below the symbol is the company name, "Reliance Orthodontic Products, Inc." in a cursive font.

Toll Free 1-800-323-4348 · Phone [phone] · Fax [phone] PO Box 678 · Itasca, IL · 60143 · U.S.A.

#### SECTION 6.0

# INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known): K07 | 1688

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Reliance S.E.P. is a one step self etching primer intended to be used for the preparation of a tooth surface prior to bonding an orthodontic appliance(s) with a light cure adhesive.

| Prescription Use <u>X</u><br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|----------------------------------------------------------|--------|------------------------------------------------|
|----------------------------------------------------------|--------|------------------------------------------------|


| Division Sign-Off) | |
|----------------------------------------------|---------|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 10(k) Number: | k071688 |

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