Optiband LC Band Cement is a light-cured orthodontic bonding cement that is intended to be used for the attachment of orthodontic appliances to teeth.

Device Description

The device is a resiri-based fluoride releasing band cement. It is a single paste so messy powder and liquid mixing is eliminated as well as inconsistent mixing of catalyst/activator type cements. Optiband LC achieves high strength following light cure allowing active archwires to be placed immediately. Optiband LC has higher tensile and compressive strength than glass ionomers or zinc phosphates and does not have an unpleasant taste or odor. It is specially formulated to have high adhesion to enamel and metal surfaces to reduce the chances of wash-out and loose bands. Optiband LC is offered in two shades, chromatic formula and blue formula.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Optiband LC device, presented in the requested format.

It's important to note that the provided text is a 510(k) summary for a dental adhesive, which focuses on substantial equivalence to a predicate device rather than a comprehensive clinical study proving specific performance metrics against pre-defined acceptance criteria with detailed statistical analysis as one might find for a more complex medical device or AI algorithm.

Therefore, many of the requested sections (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance of an algorithm, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for this particular device. The "study" here is primarily a comparison of material properties and intended use to a legally marketed predicate.

Acceptance Criteria and Device Performance for Optiband LC

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use	To be used as a light-cured orthodontic band cement for the attachment of orthodontic appliances to teeth, performing in a manner similar to legally marketed predicate devices.	Intended use is identical to the predicate: "as a light-cured orthodontic band cement that is designed for the attachment of orthodontic appliances to teeth."
Composition	Resin-based, fluoride-releasing single paste cement, without unpleasant taste or odor, designed to eliminate messy powder and liquid mixing.	"It is a resin-based fluoride releasing band cement. It is a single paste... does not have an unpleasant taste or odor."
Strength (Tensile)	Achieve high strength following light cure, allowing immediate placement of active archwires. Equivalent or superior tensile strength compared to glass ionomers or zinc phosphates.	Achieves high strength following light cure, allowing active archwires to be placed immediately. "Optiband LC has higher tensile... strength than glass ionomers or zinc phosphates."
Strength (Compressive)	Equivalent or superior compressive strength compared to glass ionomers or zinc phosphates.	"Optiband LC has higher... compressive strength than glass ionomers or zinc phosphates."
Adhesion	High adhesion to enamel and metal surfaces to reduce the chances of wash-out and loose bands. Equivalent to or better than predicate device.	"It is specially formulated to have high adhesion to enamel and metal surfaces to reduce the chances of wash-out and loose bands." (Implicitly comparable to predicate)
Cure Mechanism	Light-cured.	"following light cure", "light-cured"
Formulation	Offered in varying shades (e.g., chromatic and blue) to meet market needs.	"Optiband LC is offered in two shades, chromatic formula and blue formula."
Substantial Equivalence	To a legally marketed predicate device (3M Unitek Dental Products Division, Transbond Plus) in terms of intended use, technology, principles of operation, and performance characteristics (e.g., strength, adhesion, cure).	"Optiband LC is substantially equivalent to other legally marketed devices...functions in a manner similar to and is intended for the same use as Transbond Plus..."

Explanation of "Acceptance Criteria" for this device: For a 510(k) submission of a dental cement, acceptance criteria are generally established by demonstrating that the new device is "substantially equivalent" to an already legally marketed predicate device. This typically involves performance bench testing (e.g., tensile strength, compressive strength, bond strength) and material characterization (e.g., rheology, cure depth, fluoride release) to show that the new device performs as well as or better than the predicate for its intended use, and does not raise new questions of safety or effectiveness. The text explicitly states "higher tensile and compressive strength than glass ionomers or zinc phosphates," implying these are baseline performance requirements that the device exceeds. The comparison with Transbond Plus is for overall "substantial equivalence."

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

Sample Size: Not specified in the provided 510(k) summary. For a dental material, this would typically involve a certain number of samples tested for each material property (e.g., N=10 for bond strength, N=5 for compressive strength).
Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. This would typically be laboratory bench testing conducted by the manufacturer.

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

Not Applicable. This is a material science study of a dental adhesive, not an image analysis or diagnostic AI device where human experts establish ground truth for a test set. Performance metrics are derived from instrumental measurements (e.g., forcemeasurement devices for strength, spectrometers for material composition).

4. Adjudication Method for the Test Set

Not Applicable. As this is not an expert-driven assessment, there is no adjudication method. Results are quantitative measurements from lab tests.

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 is a dental material, not an AI or imaging device involving human readers.

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

Not Applicable. This describes a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for verifying the device's performance would be established through objective, standardized laboratory measurements of its physical and chemical properties (e.g., tensile strength, compressive strength, bond strength, fluoride release, setting time, viscosity) performed according to recognized test methods (e.g., ISO standards, ADA specifications). These are quantitative, instrumental measurements, not expert consensus or outcomes data in the usual clinical trial sense.

8. The Sample Size for the Training Set

Not Applicable/Not Explicitly Stated. For a traditional medical device like this, there isn't a "training set" in the context of machine learning. If one were to interpret "training set" as the data used during product development and formulation optimization, it would involve numerous experimental batches and tests, but a specific "sample size" for "training" is not a standard concept for this type of device and would not be reported in a 510(k) summary.

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

Not Applicable/Not Explicitly Stated. Similar to point 8, the "ground truth" during development would be the desired performance characteristics identified through scientific literature, predicate device analysis, and dental professional feedback. The "establishment" would be through iterative formulation, material characterization, and bench testing, aiming to achieve and optimize these desired properties.

Summary

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OCT = 6 2003 Section III - 510(k) Summary of Safety and

Submitter:

K032407

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: July 2003

Device Name:

Trade Name Optiband LC ●
Common Name -- Orthodontic Band Cement ●
Classification Name Bracket Adhesive Resin and Tooth Conditioner, per 2 i CFR & 872.3750 .

Devices for Which Substantial Equivalence is Claimed:

3M Unitek Dental Products Division, Transbond Plus .

Device Description:

Intended Use of the Device:

The intended use of Optiband LC is as a light-cured orthodontic band cement that is designed for the attachment of orthodontic appliances to teeth.

Substantial Equivalence:

Optiband LC is substantially equivalent to other legally marketed devices in the United States. Optiband LC functions in a manner similar to and is intended for the same use as Transbond Plus that is currently marketed by 3M Unitek Dental Products Division.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, composed of three curved lines. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 6 2003

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K032407

Trade/Device Name: Optiband LC Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: July 31, 2003 Received: August 04, 2003

Dear Ms. Boswell:

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.

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Page 2 - Ms. Colleen Boswell

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Chiu S. Lin, PhD

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section I - Indications for Use

Ver/ 3 - 4/24/96
Applicant:	Ormco Corporation
510(k) Number (if known):	K032407
Device Name:	Optiband LC
Indications For Use:
Optiband LC Band Cement is a light-cured orthodontic bonding cement that is intended to be used for the attachment of orthodontic appliances to teeth.

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:	K032407
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.