THERMA-CURE

K071590 · Reliance Orthodontic Products, Inc. · DYH · Jul 31, 2007 · Dental

Device Facts

• Record ID: K071590
• Device Name: THERMA-CURE
• Applicant: Reliance Orthodontic Products, Inc.
• Product Code: DYH · Dental
• Decision Date: Jul 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Therma-Cure is a heat cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the indirect bonding of orthodontic brackets and appliances.

Device Story

Therma-Cure is a heat-curable orthodontic adhesive used for indirect bonding of brackets and appliances. It is supplied as a single paste in a hand-held delivery system. Used in orthodontic, dental, or pediatric dental offices by clinicians. The adhesive is applied to brackets/appliances, which are then bonded to teeth using heat to cure the resin. This process facilitates the attachment of orthodontic hardware, aiding in patient orthodontic treatment. The device is non-toxic per ISO 10993-5.

Clinical Evidence

Bench testing only. In-vivo performance testing for shear bond strength was conducted using an indirect bonding procedure with replicates of 5 for both Therma-Cure and the predicate device (Light Bond). Results showed similar performance between the two adhesives. Biocompatibility testing confirmed the device is non-toxic according to ISO 10993-5.

Technological Characteristics

Heat-curable orthodontic adhesive. Composition: Bisphenol A Diglycidyl Methacrylate resin monomer, silica filler, Triethyleneglycol Dimethacrylate diluent, and 2-3-Di-tert-butyl-4-methylphenol inhibitor. Form factor: Single paste in hand-held delivery. Curing principle: Heat-activated polymerization.

Indications for Use

Indicated for indirect bonding of orthodontic brackets and appliances in pediatric to adult patients undergoing orthodontic treatment in a dental or orthodontic office setting.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Predicate Devices

• Light Bond™ Orthodontic Adhesive (K880793)

Submission Summary (Full Text)

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Reliance Orthodontic Products, Inc.

JUL 3 1 2007

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

K071590

Section 5.0

510 (k) Summary

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

510 (k) Owners Name: Reliance Orthodontic Products, Inc. Paul Gange, President

Address: 1540 West Thorndale Avenue Itasca. Il 60143 USA

Phone Number: 630-773-4009 Fax Number: 630-250-7704

Contact Person: Paula Wendland, Regulatory Affairs Manager (Preparer)

Date 510 (k) Summary was Prepared: June 4, 2007

Medical Device Name:

- Trade name -- Therma-Cure™ .
- Common name Heat Curable Orthodontic Adhesive .
- Classification name Bracket Adhesive Resin and Tooth Conditioner . (21CFR872.3750, Product Code DYH, Class II Device)

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

- Reliance Orthodontic Products, Inc. Light Bond™ Orthodontic Adhesive .

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Reliance Orthodontic Products, Inc.

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

## 5.1 DESCRIPTION OF THE APPLICANTS DEVICE:

Therma-Cure™ is a heat curable orthodontic adhesive used for the indirect bonding of orthodontic brackets and appliances.

5.2 INTENDED USE AND POPULATION:

Therma-Cure is a heat cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the indirect bonding of orthodontic brackets and appliances. The intended patient population ranges from pediatric to adult recipients of orthodontic treatment.

5.3 PREDICATE DEVICE:

Reliance Orthodontic Products Inc. Light Bond™ Orthodontic Adhesive System. 510(k) submission (K880793) dated June 13, 1988.

5.4 TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:

Performance Characteristics of Therma-Cure versus Light Bond:

| Property | Therma-Cure | Light Bond |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Heat Cure Adhesive for<br>indirect bonding | Light Cure Adhesive for<br>indirect bonding |
| Mechanical / Physical<br>Properties | Single paste in a hand-<br>held delivery | Single paste in a hand-<br>held delivery |
| Chemical Composition | Bisphenol A Diglycidyl<br>Methacrylate resin<br>Monomer and Silica<br>Filler<br>Triethyleneglycol<br>Dimethacrylate Diluent<br>2-3-Di-tert-butyl-4-<br>methylphenol Inhibitor | Bisphenol A Diglycidyl<br>Methacrylate / Urethane<br>Dimethacrylate Resin<br>Monomer and Silica<br>Filler<br>Triethyleneglycol<br>Dimethacrylate Diluent<br>2-3-Di-tert-butyl-4-<br>methylphenol Inhibitor |

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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 letter "R" inside a circle, which is placed 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 overall design is simple and elegant, conveying 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.

5.5 Summary:

Therma-Cure was tested against Light Bond using in-vivo performance test method for shear bond strength. Testing was conducted using indirect bonding procedure in replicates of 5 for both Therma-Cure and Light Bond, the predicate device. Testing resulted in similar performance between the two adhesives.

Therma-Cure has been proven to be non-toxic when tested according to ISO 10993-5.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of three human profiles facing right, stacked on top of each other. The profiles are stylized with flowing lines. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2007

Mr. Paul Gange Regulatory Affairs Manager Reliance Orthodontic Products, Incorporated 1540 West Thorndale Avenue Itasca, Illinois 60143

Re: K071590

Trade/Device Name: Therma Cure Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: June 4, 2007 Received: June 12, 2007

Dear Mr. Gange:

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. Gange

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.

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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Reliance Orthodontic Products, Inc.

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):

Therma-Cure Device Name:

Indications for Use:

Therma-Cure is a heat cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the indirect bonding of orthodontic brackets and appliances.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Abber DDS for Dr. Susan Renner

Mision Sign-Off Civision of Anesthesiology. General Hospital. Infection Control, Dental Devices

510(k) Number: K071590