Opal® Bond™ Flow is a light viscosity, light cure bonding adhesive used for bonding to etched enamel and is recommended for appliances, permanent retainers, bondable bite turbos/ramps or similar applications.

Device Description

Opal® Bond™ Flow is a light cure adhesive designed for bonding brackets other bondable appliances to etched enamel.

AI/ML Overview

The provided text describes a 510(k) submission for "Opal® Bond™ Flow," a light cure bracket adhesive. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on performance characteristics through in-house testing and comparisons.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes desired outcomes relative to competitors for each functional test performed. The reported device performance is described as "as well or better than the predicate devices currently on the market."

Function	Acceptance Criteria (Desired Outcome described)	Reported Device Performance
Shear Peel	Higher adhesion onto brackets compared to competitors (acceptable and preferred).	Performs as well or better than predicate devices.
Flexural Strength	Higher number than competitors (good). Modulus side comparable to most competitors.	Performs as well or better than predicate devices.
Hardness	Within competitors' range.	Performs as well or better than predicate devices.
Shear Bond (with bracket)	Highest value compared to competitors acceptable.	Performs as well or better than predicate devices.
Compressives	High numbers compared to competitors acceptable.	Performs as well or better than predicate devices.
Metal Shear	Both measures high or higher than competitors.	Performs as well or better than predicate devices.
Depth of Cure	At the high end of competitors.	Performs as well or better than predicate devices.
Tensile Pull	(No specific criteria described, only that it measures force to pull off a bracket.)	Performs as well or better than predicate devices.
Ambient Light Sensitivity	Low times for working and cure time.	Performs as well or better than predicate devices.
Sorption	Low readings.	Performs as well or better than predicate devices.
Stain Testing	Low score (1 being lowest, less staining).	Performs as well or better than predicate devices.

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

Test Set Sample Size: The document does not specify the exact sample sizes used for each of the bench tests (Shear Peel, Flexural Strength, etc.). It only states that these tests were "conducted during the R & D phase on Opal® Bond MV and compared to 3M Unitek's Transbond and Transbond LV (K073697) and Reliance's Flow-Tain LV (K083051)."
Data Provenance: The data is from "in-house testing" conducted during the R&D phase by Opal Orthodontics. It is retrospective for the purpose of this 510(k) submission, as it was performed prior to the submission. The country of origin of the data is implicitly the USA, where Opal Orthodontics is located.

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

There were no human experts used to establish "ground truth" for the performance tests. The "ground truth" for these physical and chemical property tests is derived directly from the laboratory measurements and comparisons to predicate devices, following established scientific and industrial standards for materials testing in dentistry.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements of material properties, not subjective assessments requiring expert 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 a dental adhesive, not an imaging or diagnostic AI-assisted device. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.

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

Not applicable. This device is not an algorithm or software. It is a physical dental adhesive.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" is based on objective physical and chemical property measurements and comparative performance against legally marketed predicate devices, as well as adherence to established industry standards for testing such materials. There is no mention of pathology, outcomes data, or expert consensus in establishing the ground truth for these specific material performance tests.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for a physical product.

Summary

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K|0030|

Section 5

APR 2 9 2010

Traditional 510(k) Summary

This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 .92.

Applicant's Name and Address

Opal Orthodontics by Ultradent Products Inc. 505 West 10200 South South Jordan, UT 84095

ﺎ ﺗ

Contact Person:
Title:
Telephone:
FAX:
Date Summary Prepared:

Diane Rogers Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 January 29, 2010

Name of the Device

Trade Name: Common Name: Device Classification: Classification Product Code: Opal® Bond™ Flow Bracket Adhesive Resin and Tooth Conditioner ll DYH

Legally Marketed Predicate Devices to Which Equivalence is Claimed

The predicate devices are: 3M Unitek's Transbond and Transbond LV (K073697) and Reliance's Flow-Tain LV (K083051).

Description of Device: Opal® Bond™ Flow is a light cure adhesive designed for bonding brackets other bondable appliances to etched enamel.

Intended Use of the Device: Opal® Bond™ Flow is a light viscosity, light cure bonding adhesive used for bonding to etched enamel and is recommended for appliances, permanent retainers, bondable bite turbos/ramps or similar applications. This product can be used for patients of all ages.

Opal Orthodontics

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The following table shows that each of these devices are similar as test results comparing these devices show similar results. The devices are so equivalent that each of these companies follow standards that show us how to test this type of a device and in Section 18 "Performance and Bench", you will see that test results show the devices have the same technological characteristics.

Function	Opal® Bond™ Flow	Transbond LR andSupreme LV (K073697)	Reliance's Flow-Tainand Flow-Tain LV(K083051).
Shear Peel	X	X	X
Flexural Strength	X	X	X
Hardness	X	X	X
Shear Bond	X	X	X
Compressives	X	X	X
Metal Shear	X	X	X
Depth of Cure	X	X	X
Tensile Pull	X	X	X
Ambient Light	X	X	X
Sorption	X	X	X
Stain Testing	X	X	X

Similarities in the Indications for Use:

Opal® Bond™ Flow	New	Adhesive, Bracket andTooth Conditioner	Opal® Bond™ Flow is a lightviscosity, light cure bondingadhesive used for bonding to etchedenamel and is recommended forappliances, permanent retainers,bondable bite turbos/ramps orsimilar applications.
3M Unitek's TransbondSupreme LV(K073697)	K071055	Adhesive, Bracket andTooth Conditioner	Transbond Supreme LV LowViscosity Light Cure Adhesive is aflowable orthodontic adhesiveadvantageous for indirectbonding or wherever a flowablelight cure adhesive may beindicated.
Reliance's Flow-TainLV (K083051)	K083051	Adhesive, Bracket andTooth Conditioner	Flow Tain LV is a lower viscosity,flowable light cure orthodonticadhesive intended to be used forindirect bonding of orthodonticbrackets."

Opal Orthodontics

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Brief Description of Testing Performed

The following tests were conducted during the R & D phase on Opal® Bond MV and compared to 3M Unitek's Transbond and Transbond LV (K073697) and Reliance's Flow-Tain LV (K083051).

Shear Peel This test shows higher adhesion onto brackets. A high number compared to our a. competitors is acceptable and preferred.
b. Flexural Strength This test will show the strength of the bond during stress. A higher number than our competitors is good. The modulus side of this test shows the strength at which flexing the bond occurs. We prefer the product to be comparable to most of our competitors. One competitor shows a higher reading and we believe that shows brittleness in the bond.
c. Hardness This test shows the hardness of the bond. We prefer to stay within our competitors range. However, one competitor shows a high reading and along with Flexural Strength, this can show brittleness.
d. Shear Bond with bracket This test shows the absolute strength of the bracket. The highest value according to our competitors is acceptable.
Compressives This test shows different forces on the resin. High numbers according to our e. competitors is acceptable.
Metal Shear This test measures the strength of the product's bonding to metal. It is measured f. in two ways. Both numbers should be high or higher than our competitors.
Depth of Cure This test shows how far a curing light penetrates into the cure. We want to stay g. at the high end of our competitors.
h. Tensile Pull This test measure the force to pull a bracket off of a tooth.
Ambient Light Sensitivity -- This test shows the that the product will cure in ambient light. It i. shows working time with the product and cure time of the product. We want low times in this category.
Sorption This test shows how much water the resin absorbs. We want low readings on this j. test.
k. Stain Testing We tested our product against our competitors to measure how much staining occurs with different fruits and spices. A score of1 was the lowest, less staining and a score of 5 was highest staining. It also shows us which products we should avoid if we don't want stained teeth!

Clinical Summary

Opal® Bond™ Flow is a resin based material that is light cured to adhere orthodontic appliances to teeth. Opal® Bond™ Flow is designed to bond the appliances effectively to enamel while allowing for easy removal at the appropriate time. The materials used in Opal® Bond™ Flow are the same as used by our predicates, 3M Unitek's Transbond and Transbond LV (K073697) and Reliance's Flow-Tain LV (K083051). These materials have been widely used by numerous manufacturer in the medical/dental industry.

In performing research for this summary, a PubMed search was conducted using the keywords "Orthodontic Bracket Bonding Materials". Twenty six articles were found, of which 7 were most relevant to Opal® Bond™ Flow and Indirect Bonding. Redundant articles and articles unrelated

Opal Orthodontics

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to the safety and efficacy of Opal Bond MV were not included. Copies of the articles are attached to this section.

The efficacy or suitability to the intended purpose of Opal® Bond™ Flow has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market. Results of our bench testing indicates that Opal® Bond™ Flow performs as well or better than the predicate devices currently on the market.

Summary Risk/Benefit Review

Considering the safe history of our predicates, 3M Unitek's Transbond and Transbond LV (K073697) and Reliance's Flow-Tain LV (K083051). Opal®Bond™ Flow, is considered a safe medical device. Our records indicate that our predicates have been used by many dentists and large group practices in the United States and purchased by a large number of international distributors. To date, there have been no reported complaints of local or systemic adverse effects associated with the use of these products.

In conclusion, Opal® Bond™ Flow has been designed and manufactured with the intended use and claims for the product in mind. Scientific literature, etc. has been collected and evaluated to determine safety and efficacy of similar products used for the same indication. Following the clinical review as documented above, Opal Orthodontics by Ultradent Products, Inc. deems that when this device is used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of the patient and the association with its use constitutes acceptable risks when weighed against the benefits to the patient. Therefore, the product is compatible with a high level of protection of health and safety and may be released to the market.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Diane Rogers Regulatory Affairs Product Specialist Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

APR 2 9 2010

Re: K100301

Trade/Device Name: Opal® Bond™ Flow Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: April 13, 2010 Received: April 15, 2010

Dear Ms. Rogers:

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. Rogers

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/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 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.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 yours,

h for

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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Statement of Indications for Use

10030 510(k) Number (if known):

Opal® Bond™ Flow 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Maluy for MSK

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

10030 510(k) Number:

Page 1 of 1

(Posted November 13, 2003)

Opal Orthodontics

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.