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.

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.

AI/ML Overview

This document is a 510(k) summary for a medical device called L.C.R.™, a light-cure orthodontic adhesive. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, Flowtain™.

Here's an analysis of the acceptance criteria and the study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (from Predicate Device)	L.C.R.™ Reported Performance
Intended Use	Light Cure adhesive for bonding lingual retainers, and retention of thermoplastic aligners	Light Cure adhesive for bonding lingual retainers, creation of occlusal buildups 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	Syringe and Tips
Flexural Strength	Performance consistent with ISO 4049:2009 requirements	Performance consistent with ISO 4049:2009 requirements (tested via ISO 4049:2009(E))
Depth of Cure	Performance consistent with ISO 4049:2009 requirements	Performance consistent with ISO 4049:2009 requirements (tested via ISO 4049:2009(E))
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.
Compressive Strength (for occlusal buildups)	(Implicitly, "effective" performance for the intended use)	"Acceptable results were obtained"
Oral Toxicity	(Implicitly, no significant toxicity)	"no significant evidence of toxicity"

2. Sample Size Used for the Test Set and Data Provenance

Flexural Strength & Depth of Cure: The document states "L.C.R.™ was tested and compared to Flowtain™ for Flexural Strength and Depth of Cure via ISO 4049:2009(E) test method." While the standard ISO 4049:2009(E) specifies methodology, the exact sample size used for this specific study is not explicitly mentioned in the provided text.
Compressive Strength: "five replicates" were conducted for the Compressive Strength Test.
Oral Toxicity: "a 10 Mouse, 7 Day Method (Solid)" was used.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of material property testing, these would typically be laboratory-based prospective studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish a "ground truth" in the traditional sense of clinical outcome assessment for the performance tests (Flexural Strength, Depth of Cure, Compressive Strength, Oral Toxicity). These are objective, quantitative laboratory measurements.

For the "Bonding of Lingual Retainers" and "Bonding of Thermoplastic Aligners" properties, the descriptions ("Successful bond," "Adhesive created retentive surface") suggest qualitative assessments, but no information about experts or their qualifications is provided.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are primarily objective laboratory measurements rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an orthodontic adhesive, not an AI software or imaging interpretation tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical medical device (an adhesive), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics (Flexural Strength, Depth of Cure, Compressive Strength) is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ISO 4049:2009(E)). For oral toxicity, the ground truth is established by the observed biological response in the mouse model. For bonding efficacy, the "successful bond" or "retentive surface" acts as a qualitative ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not a machine learning model, so there is no training set in the AI sense. The development of the adhesive likely involved internal R&D tests, but these are not described as a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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 AvenueItasca, Il 60143 USA
Phone Number:Fax Number:	630-773-4009630-250-7704
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™ .

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Reliance Orthodontic Products, Inc.

5.1 DESCRIPTION OF THE APPLICANTS DEVICE:

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.

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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.

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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.

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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:

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

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.