(111 days)
No
The summary describes a light-cure orthodontic adhesive and its bonding properties, with no mention of AI or ML.
No
Explanation: A therapeutic device is one that treats or prevents a disease or condition. This device is an adhesive used to bond orthodontic brackets and appliances to teeth, which is a supportive function and not directly therapeutic.
No
This device is an adhesive used for bonding orthodontic brackets, not for diagnosing conditions. Its primary function is to physically attach something to a tooth surface.
No
The device description clearly states it is a light-cure 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 is "as a light cure, orthodontic adhesive" for bonding brackets and appliances to a tooth surface. This is a direct application to the body (the tooth surface) for a structural purpose.
- Device Description: The description reinforces its use as an adhesive for bonding to tooth surfaces.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any such specimens.
The device is a medical device, specifically a dental adhesive, but it falls under the category of devices used directly on the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
This Device is intended for use as a light cure, orthodontic adhesive.
Product codes
DYH
Device Description
This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
The Quantum LB was tested against Transbond™ XT using in-vivo performance test method for shear bond strength. Testing resulted in similar performance between the two adhesives.
A biocompatibility evaluation was conducted per ISO10993 for the composition of the Quantum LB device and determined to not directly or through the release of material constituents produce adverse local or systemic effects.
In addition, Cytotoxicity testing was conducted on Quantum LB using the ISO 10993-5 Elution Method. The Quantum LB was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test following the guidelines of ISO10993-5, Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity. The Quantum LB showed no evidence of causing cell lysis or toxicity and met the requirements of the test with a grade of less than grade 2 (Mild reactivity).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized representation of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, abstract design. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Reliance Orthodontic Products Inc. Paula Wendland Regulatory Affairs Manager 1540 West Thorndale Ave Itasca, Illinois 60143
Re: K161684
Trade/Device Name: Quantum LB Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin And Tooth Conditioner Regulatory Class: Class II Product Code: DYH Dated: June 15, 2016 Received: June 17, 2016
Dear Paula 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runno DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem on the left, containing the letter 'R' in a stylized font. To the right of the emblem is the company name, "Reliance Orthodontic Products, Inc.", written in an elegant, cursive typeface. A thin line underlines the text, adding a touch of sophistication to the overall design.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 P.O. Box 678, 1540 West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.
SECTION 6.0 INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): __K161684 __________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
This Device is intended for use as a light cure, orthodontic adhesive.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem on the left, containing the letter "R" in a stylized font. To the right of the emblem is the company name, "Reliance Orthodontic Products, Inc.", written in an elegant, cursive typeface with a line underneath.
800-323-4348 · Phone 630-773-4009 · Fax 630-25 x 678, 1540 West Thorndale Ave. · Itasca, IL · 60143 ·
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/Owner
Address: 1540 West Thorndale Ave. Itasca, IL 60143 USA
Contact Phone Number: 630-773-4009 Fax Number: 630-250-7704
Contact Person: Paula Wendland, Regulatory Affairs Manager
Date 510(k) Summary was Prepared: May 31st, 2016
Medical Device Name:
- Trade name Quantum LB .
- Common name Orthodontic Bracket Adhesive .
- Classification name -- Adhesive, Bracket and Tooth Conditioner, Resin o (21CFR872.3750, Product Code DYH, Class II Device)
LEGALLY MARKETED DEVICES TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]:
- Transbond XT 510(k) K880393 0
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Image /page/4/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo features a circular emblem with the letters "R" and "P" intertwined. The company name is written in a cursive font to the right of the emblem. A horizontal line is underneath the company name.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 P.O. Box 678, 1540 West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.
5.1 DESCRIPTION OF THE APPLICANTS DEVICE:
This device is a light-cure orthodontic adhesive intended for bonding brackets and appliances to a tooth surface. This device will bond to any enamel, porcelain, composite or metal tooth surface that has been properly conditioned. This device will be available in push syringe or tips for preferences in dispensing.
5.2 INTENDED USE AND POPULATION:
This device is intended for use as a light cure, orthodontic adhesive.
5.3 PREDICATE DEVICE:
3M Unitek Transbond XT, 510(k) submission (K880393) dated 3/31/1998 is similar in intended use, handling and technology compared to the device described in this submission.
| Property | QUANTUM LB | TRANSBOND XT |
|---|---|---|
| Intended Use | Light Cure Orthodontic | |
| Adhesive | Light Cure Orthodontic | |
| Adhesive |
5.4 TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS.
| Intended Use | Light Cure Orthodontic Adhesive | Light Cure Orthodontic Adhesive |
|---|---|---|
| Composition | Methacrylate Monomer | Methacrylate Monomer |
| Product Features | Bonds to conditioned Enamel, Composite, Porcelain and Metal tooth surfaces. | Bonds to conditioned Enamel, Porcelain and Metal tooth surfaces. |
| Dispensing Method | Push Syringe and Tips | Push Syringe and Tips |
| Method of Cure | Light Cure | Light Cure |
5.5 Summary:
The Quantum LB was tested against Transbond™ XT using in-vivo performance test method for shear bond strength. Testing resulted in similar performance between the two adhesives.
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Image /page/5/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo consists of a circular emblem with the letter "R" inside, followed by the company name written in a cursive font. The words "Reliance Orthodontic Products, Inc." are underlined with a thin 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 P.O. Box 678, 1540 West Thorndale Ave. Itasca, IL · 60143 ·
A biocompatibility evaluation was conducted per ISO10993 for the composition of the Quantum LB device and determined to not directly or through the release of material constituents produce adverse local or systemic effects.
In addition, Cytotoxicity testing was conducted on Quantum LB using the ISO 10993-5 Elution Method. The Quantum LB was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test following the guidelines of ISO10993-5, Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity. The Quantum LB showed no evidence of causing cell lysis or toxicity and met the requirements of the test with a grade of less than grade 2 (Mild reactivity).
Audume 10.6.16