(106 days)
Not Found
No
The summary describes a light-cure orthodontic adhesive and its physical properties and performance testing. There is no mention of AI or ML technology.
No
The device is an adhesive used for bonding in orthodontic procedures, not for treating a disease or condition.
No
The device is an adhesive used for bonding and retention, not for diagnosing medical conditions. Its intended uses (bonding retainers, creating buildups, retaining aligners) are therapeutic or corrective in nature, not diagnostic.
No
The device description clearly states it is a "flowable, 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 clearly states that the device is an "orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for the retention of thermo-plastic aligners." This describes a device used directly on a patient for a therapeutic or structural purpose within the mouth.
- Device Description: The description reinforces that it's a "light-cure orthodontic adhesive" with properties suitable for bonding and creating structures in the mouth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are used to perform tests on samples taken from the human body to provide diagnostic information. This device is a material used directly in the mouth for a structural and retentive purpose.
N/A
Intended Use / Indications for Use
L.C.R." is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for the retention of thermo-plastic aligners.
Product codes
DYH
Device Description
L.C.R."" is a light-cure orthodontic adhesive that is flowable and a highly filled resin in order to provide durability. These properties make it ideal for bonding lingual retainers, creating occlusal buildups and for the retention of a thermoplastic aligner.
L.C.R is available in push syringe, luer-lok 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthodontic, dental or pediatric dental office
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"L.C.R. "" was tested and compared to Flowtain"" for Flexural Strength and Depth of Cure via ISO 4049:2009(E) test method. Testing resulted in similar performance between the two adhesives for both Flexural Strength and Depth of Cure.
In addition, five replicates of a Compressive Strength Test were conducted for occlusal build-up suitability. This testing was conducted to show the intended use of L.C.R. " for this procedure was effective. Acceptable results were obtained for Compressive Strength.
For safety, L.C.R. "" has been tested via an Oral Toxicity Study using a 10 Mouse, 7 Day Method (Solid). L.C.R. "" showed no significant evidence of toxicity.
Based on the data comparison between LCR™ and the predicate device, Flowtain™, the intended use testing and oral toxicity study, LCR " was determined to be safe and effective for its intended use. Testing against the predicate device showed equivalent performance."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
રાજીન્દ દિવસ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય
ic 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.
OCT 2 6 2010
| 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: | |
| Fax Number: | 630-773-4009 |
| 630-250-7704 | |
| Contact Person: | Paula Wendland, Regulatory Affairs Manager (Preparer) |
| Date 510 (k) Summary was Prepared: June 24th, 2009 |
Medical Device Name:
- Trade name L.C.R.™ .
- Common name Flowable Light Cure 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)]:
Flowtain™ .
1
®
Reliance Orthodontic Products, Inc.
5.1 DESCRIPTION OF THE APPLICANTS DEVICE:
L.C.R."" is a light-cure orthodontic adhesive that is flowable and a highly filled resin in order to provide durability. These properties make it ideal for bonding lingual retainers, creating occlusal buildups and for the retention of a thermoplastic aligner.
L.C.R is available in push syringe, luer-lok syringe or tips for preferences in dispensing.
5.2 INTENDED USE AND POPULATION:
L.C.R." is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers. creation of occlusal buildups and for the retention of thermo-plastic aligners.
5.3 PREDICATE DEVICE:
Reliance Orthodontic Products, Inc. Flowtain™, 510(k) submission (K083051) dated 02/20/2009.
2
Reliance Orthodontic Products, Inc.
5.4 TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:
Performance Characteristics comparison of L.C.R. "" versus Flowtain" :
| Property | LCRTM | FlowtainTM |
|---|---|---|
| Intended Use | Light Cure adhesive for bonding lingual retainers, creation of occlusal buildups and retention of thermoplastic aligners | Light Cure adhesive for bonding lingual retainers, and retention of thermoplastic aligners |
| Mechanical / Physical Properties | Flowable Composite Light Cure | Flowable Composite Light Cure |
| Storage | Room Temperature | Room Temperature |
| Shelf Life | 2 years | 2 years |
| Delivery | Syringe and Tips | Syringe |
| Flexural Strength | Performance consistent with ISO 4049:2009 requirements | Performance consistent with ISO 4049:2009 requirements |
| Depth of Cure | Performance consistent with ISO 4049:2009 requirements | Performance consistent with ISO 4049:2009 requirements |
| Bonding of Lingual Retainers | Successful bond of wire to tooth withstanding multidirectional force | Successful bond of wire to tooth withstanding multidirectional force |
| Bonding of Thermoplastic Aligners | Adhesive created retentive surface for thermoplastic aligner. | Adhesive created retentive surface for thermoplastic aligner. |
5.5 Summary:
LCR™ claims substantial equivalence to the product, Flowtain™ (K083051). L.C.R. "" was tested and compared to Flowtain"" for Flexural Strength and Depth of Cure via ISO 4049:2009(E) test method. Testing resulted in similar performance between the two adhesives for both Flexural Strength and Depth of Cure.
3
Image /page/3/Picture/0 description: The image shows the logo for Reliance Orthodontic Products, Inc. The logo consists of a stylized "R" enclosed in a circle, followed by the company name written in a cursive font. The words "Reliance Orthodontic Products, Inc." are all on one line.
In addition, five replicates of a Compressive Strength Test were conducted for occlusal build-up suitability. This testing was conducted to show the intended use of L.C.R. " for this procedure was effective. Acceptable results were obtained for Compressive Strength.
For safety, L.C.R. "" has been tested via an Oral Toxicity Study using a 10 Mouse, 7 Day Method (Solid). L.C.R. "" showed no significant evidence of toxicity.
Based on the data comparison between LCR™ and the predicate device, Flowtain™, the intended use testing and oral toxicity study, LCR " was determined to be safe and effective for its intended use. Testing against the predicate device showed equivalent performance.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Paula Wendland Regulatory Affairs Manager Reliance Orthodontic Products, Incorporated 1540 West Thorndale Avenue Itasca, Illinois 60143
OCT 2 6 2010
Re: K101951 Trade/Device Name: L.C.RTM Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: October 8, 2010 Received: October 8, 2010
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.
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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 reportung (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/ucm115809.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 notifice: "on" (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.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 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 vours.
Susan Dunne.
Anthony 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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| (R) |
|---|
| Reliance Orthodontic Products, Inc. |
SECTION 6.0 INDICATIONS FOR USE STATEMENT
Indications for Use
OCT 2 6 2010
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
L.C.R." is a flowable, light-cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for the retention of thermo-plastic aligners.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Susa Ruane
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101951