THERMA-CURE by RELIANCE ORTHODONTIC PRODUCTS, INC.

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 Description

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

AI/ML Overview

The provided text describes the 510(k) summary for the device "Therma-Cure™", a heat-curable orthodontic adhesive, and its comparison to a predicate device, "Light Bond™ Orthodontic Adhesive". The study focused on demonstrating substantial equivalence, primarily through performance testing.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Therma-Cure)
Intended Use	Light Cure Adhesive for indirect bonding (as per predicate device, Light Bond)	Heat Cure Adhesive for indirect bonding
Mechanical / Physical Properties	Single paste in a hand-held delivery (as per predicate device, Light Bond)	Single paste in a hand-held delivery
Chemical Composition	Bisphenol A Diglycidyl Methacrylate / Urethane Dimethacrylate Resin Monomer and Silica Filler Triethyleneglycol Dimethacrylate Diluent 2-3-Di-tert-butyl-4-methylphenol Inhibitor (as per predicate device, Light Bond)	Bisphenol A Diglycidyl Methacrylate resin Monomer and Silica Filler Triethyleneglycol Dimethacrylate Diluent 2-3-Di-tert-butyl-4-methylphenol Inhibitor
Shear Bond Strength	Not explicitly stated as a numerical acceptance criterion, but the implied criterion is similar performance to the predicate device, Light Bond, when tested using an in-vivo performance test method. This means the shear bond strength should be within an acceptable range of the predicate, indicating comparable adhesive strength for orthodontic bracket retention.	The study reported "similar performance" to the predicate device for shear bond strength using an in-vivo performance test method. No specific numerical values were provided.
Non-toxicity	The device must be non-toxic, conforming to applicable biocompatibility standards. The implied acceptance criterion would be passing the requirements of ISO 10993-5 (tests for in vitro cytotoxicity).	Therma-Cure has been proven to be non-toxic when tested according to ISO 10993-5.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "replicates of 5 for both Therma-Cure and Light Bond" were used for the shear bond strength testing. This means 5 samples for the Therma-Cure device and 5 samples for the Light Bond device, for a total of 10 samples in the test.
- Data Provenance: The study states "in-vivo performance test method". While it doesn't explicitly state the country of origin, the FDA submission context implies the data would be relevant to U.S. regulatory standards. It is a prospective study as it involves conducting new tests for regulatory submission.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the given text. The study describes "in-vivo performance test method" for shear bond strength, which is a laboratory or clinical measurement rather than an expert interpretation task. For the non-toxicity test, reference to ISO 10993-5 implies standard toxicology protocols were followed, not expert consensus on ground truth.
Adjudication Method for the Test Set:
- Not applicable. The tests described are objective performance measurements (shear bond strength, non-toxicity) rather than subjective assessments requiring adjudication among experts.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was not an MRMC study. The device is an orthodontic adhesive, not an AI-powered diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to this submission.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical product (adhesive), not an algorithm or AI system.
The Type of Ground Truth Used:
- For Shear Bond Strength: The ground truth was established through a direct, objective measurement using an "in-vivo performance test method." The predicate device's performance served as the comparative "ground truth" for demonstrating substantial equivalence.
- For Non-Toxicity: The ground truth was established by adherence to the objective test standards outlined in ISO 10993-5.
The Sample Size for the Training Set:
- Not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a physical adhesive, this question does not apply.

Summary

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Reliance Orthodontic Products, Inc.

JUL 3 1 2007

Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 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 630-773-4009 · Fax 630-250-7704 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 forindirect bonding	Light Cure Adhesive forindirect bonding
Mechanical / PhysicalProperties	Single paste in a hand-held delivery	Single paste in a hand-held delivery
Chemical Composition	Bisphenol A DiglycidylMethacrylate resinMonomer and SilicaFillerTriethyleneglycolDimethacrylate Diluent2-3-Di-tert-butyl-4-methylphenol Inhibitor	Bisphenol A DiglycidylMethacrylate / UrethaneDimethacrylate ResinMonomer and SilicaFillerTriethyleneglycolDimethacrylate Diluent2-3-Di-tert-butyl-4-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 630-773-4009 · Fax 630-250-7704 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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 630-773-4009 · Fax 630-250-7704 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

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
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.(b)
Classification. Class II.