(50 days)
Not Found
No
The summary describes a heat-curable adhesive and its performance testing against a predicate device, with no mention of AI or ML technologies.
No.
The device is an adhesive used for bonding orthodontic brackets and appliances, not directly for therapy.
No
Explanation: This device is an orthodontic adhesive used for bonding brackets, which is a treatment material, not a diagnostic tool.
No
The device description clearly states it is a "heat curable orthodontic adhesive," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Therma-Cure is an orthodontic adhesive used for bonding brackets and appliances within the mouth of a patient.
- Device Description: It describes an adhesive used for bonding in vivo.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any such analysis on specimens.
Therefore, Therma-Cure is a medical device used for treatment within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
Therma-Cure™ is a heat curable orthodontic adhesive used for the indirect bonding of orthodontic brackets and appliances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The intended patient population ranges from pediatric to adult recipients of orthodontic treatment.
Intended User / Care Setting
orthodontic, dental or pediatric dental office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reliance Orthodontic Products Inc. Light Bond™ Orthodontic Adhesive System. 510(k) submission (K880793)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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 .
1
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 for | |
| indirect bonding | Light Cure Adhesive for | |
| indirect bonding | ||
| Mechanical / Physical | ||
| Properties | Single paste in a hand- | |
| held delivery | Single paste in a hand- | |
| held delivery | ||
| Chemical Composition | Bisphenol A Diglycidyl | |
| Methacrylate resin | ||
| Monomer and Silica | ||
| Filler | ||
| Triethyleneglycol | ||
| Dimethacrylate Diluent | ||
| 2-3-Di-tert-butyl-4- | ||
| methylphenol Inhibitor | Bisphenol A Diglycidyl | |
| Methacrylate / Urethane | ||
| Dimethacrylate Resin | ||
| Monomer and Silica | ||
| Filler | ||
| Triethyleneglycol | ||
| Dimethacrylate Diluent | ||
| 2-3-Di-tert-butyl-4- | ||
| methylphenol Inhibitor |
2
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.
3
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.
4
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
5
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