(79 days)
Not Found
No
The summary describes a chemical adhesive product and makes no mention of AI or ML technology.
No
The device is described as an "orthodontic bracket adhesive" used for bonding brackets. It does not exert any direct therapeutic action on the patient's body or disease state, but rather serves as a means of affixing a medical device (orthodontic brackets).
No
Explanation: The device is described as an "orthodontic bracket adhesive" used for bonding, not for identifying a disease or condition. Its purpose is to physically attach orthodontic brackets.
No
The device description clearly states that Light Bond and Pad Lock are "light cure, orthodontic bracket adhesives," which are physical materials, 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 an orthodontic bracket adhesive." This is a device used in vivo (on a living patient) to bond brackets to teeth.
- Device Description: The description confirms it's an adhesive for bonding to tooth surfaces.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are typically used for tests on samples like blood, urine, tissue, etc., to diagnose or monitor conditions. This device is a therapeutic/restorative device used directly on the patient.
N/A
Intended Use / Indications for Use
Light Bond adhesives are intended for use as a light cure bracket and lingual retainer adhesive.
Pad Lock adhesives are intended for use as a light cure bracket adhesive.
Light Bond is intended for use as an orthodontic bracket adhesive.
Pad Lock® is intended for use as a fluorescing, light cure Orthodontic Bracket Adhesive.
Product codes (comma separated list FDA assigned to the subject device)
DYH
Device Description
Light Bond and Pad Lock are light cure, orthodontic bracket adhesives available in a variety of viscosities for bonding to metal, ceramic and composite surfaces. Both Light Bond and Pad Lock are available in fluoride and non-fluoride formulas and come in syringe style or tip dispensing.
In addition, Pad Lock fluoresces to ease clean-up of flash for the user.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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.
K 111814
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 1540 West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.
SEP 1 4 2011
Section 8.0
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
1540 West Thorndale Avenue Address: 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 16, 2011
Medical Device Name:
- Trade names Light Bond™ and Pad Lock® .
- Common name -Orthodontic Bracket Adhesives .
- 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)]: QUICK CURE, K001048, approved 4/27/00.
1
Reliance Orthodontic Products, Inc.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 1540 West Thorndale Ave. · Itasca. IL · 60143 · U.S.A.
8.1 DESCRIPTION OF THE APPLICANTS DEVICE:
Light Bond and Pad Lock are light cure, orthodontic bracket adhesives available in a variety of viscosities for bonding to metal, ceramic and composite surfaces. Both Light Bond and Pad Lock are available in fluoride and non-fluoride formulas and come in syringe style or tip dispensing.
In addition, Pad Lock fluoresces to ease clean-up of flash for the user.
8.2 INTENDED USE AND POPULATION:
Light Bond adhesives are intended for use as a light cure bracket and lingual retainer adhesive.
Pad Lock adhesives are intended for use as a light cure bracket adhesive.
8.3 PREDICATE DEVICE:
Reliance Orthodontic Products, Inc. Quick Cure™, 510(k) submission (K001048) dated 04/28/2000
8.4 TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:
Performance Characteristics of Light Bond "", Pad Lock and Quick Cure" :
| Property | Light Bond™ | Pad Lock® | Quick Cure™ |
|---|---|---|---|
| Intended Use | Light Cure | ||
| Orthodontic bracket | |||
| adhesive | |||
| Containing Fluoride | Light Cure | ||
| Orthodontic Bracket | |||
| Adhesive | |||
| Containing Fluoride | Light Cure adhesive for | ||
| bonding Orthodontic | |||
| brackets | |||
| Containing Fluoride | |||
| Mechanical / | |||
| Physical | |||
| Properties | Syringe or Tip Delivery | Syringe or Tip Delivery | Syringe or Tip Delivery |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002
Ms. Paula Wendland. ASO COE Regulatory Affairs Manager Reliance Orthodontic Products. Incorporated 1540 West Thorndate Avenue Itasca, Illinois 60143
SEP 14 2001
Re: K111814
Trade/Device Name: Light Bond™ and Pad Lock® Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: August 22, 2011 Received: August 24, 2011
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. 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.
3
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); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1.1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.ida.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh fac
Anthony D. Watson, B.S., M.S., M.B.A. 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/4/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo includes the registered trademark symbol. Above the company name is a handwritten signature or mark that includes the number 111814.
Toll Free 1-800-323-4348 · Phone 630-773-4009 · Fax 630-250-7704 1540 West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.
3.2 Indications for Use Statement:
8945000 510 (k) Number (if known):
Device Name:
Indications for Use:
Light Bond is intended for use as an orthodontic bracket adhesive.
Pad Lock® is intended for use as a fluorescing, light cure Orthodontic Bracket Adhesive.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- | -- |
Susan Runge
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K111814 | Page 15 |
|---|---|---|
| ---------------- | --------- | --------- |