OPAL BOND MV

K094006 · Ultradent Products, Inc. · DYH · Mar 23, 2010 · Dental

Device Facts

• Record ID: K094006
• Device Name: OPAL BOND MV
• Applicant: Ultradent Products, Inc.
• Product Code: DYH · Dental
• Decision Date: Mar 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.

Device Story

Opal® Bond MV is a light-cure orthodontic adhesive resin used by orthodontists to bond brackets and appliances to etched enamel. The device is applied manually by the clinician to the bracket base or tooth surface, then cured using a light source to achieve adhesion. It functions as a restorative dental material to secure orthodontic hardware during treatment. The device is used in a clinical setting to facilitate fixed orthodontic therapy, providing mechanical retention of appliances to the tooth structure.

Clinical Evidence

The submission includes a clinical summary supported by selected literature regarding the safety and efficacy of the adhesive. No specific clinical trial data or performance metrics (e.g., sensitivity/specificity) were provided in the summary; evidence relies on bench testing comparisons (shear peel, flexural strength, hardness, shear bond, compressive strength, metal shear, depth of cure, and ambient light sensitivity) against predicate devices.

Technological Characteristics

Light-cure orthodontic adhesive resin. Materials and chemical composition are similar to predicate Opal Bond. Characteristics include shear bond strength, flexural strength, and depth of cure. No specific ASTM standards or software components are described.

Indications for Use

Indicated for bonding orthodontic brackets and bondable appliances to etched enamel in patients requiring orthodontic treatment.

Regulatory Classification

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.

Predicate Devices

• Opal Bond (K071055)
• 3M Unitek Transbond (K073609)

Reference Devices

• 3M Unitek's Transbond (K073697)
• Transbond XT Light Cure Orthodontic Adhesive (K073698)

Submission Summary (Full Text)

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K094006

# Section 5

MAR 2 3 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

| Contact Person: | Diane Rogers |
|------------------------|----------------------------------|
| Title: | Regulatory Affairs Manager |
| Telephone: | 800-552-5512 x4491, 801-553-4491 |
| FAX: | 801-553-4609 |
| Date Summary Prepared: | December 23, 2009 |

#### Name of the Device

| Trade Name: | Opal® Bond MV |
|------------------------------|----------------------------------------------|
| Common Name: | Bracket Adhesive Resin and Tooth Conditioner |
| Device Classification: | II |
| Classification Product Code: | DYH |

#### Legally Marketed Predicate Devices to Which Equivalence is Claimed

The predicate device is: Opal Bond (K071055). This device is manufactured and distributed by Opal Orthodontics by Ultradent Products, Inc., 505 West, 10200 South, South Jordan,Utah 84095. The Indications for Use have been changed.

Opal® Bond MV is also very similar to one of our competitor's products namely: 3M Unitek Transbond (K073609) Both products are used to adhere brackets and bondable appliances to etched enamel.

Substantial equivalence: Opal® Bond MV formula is similar to Ultradent's Opal Bond (K071055) formula.

Opal® Bond MV is also very similar to one of our competitor's products namely: 3M Unitek's Transbond (K073697).

Opal Orthodontics

Traditional 510(k) Submission for Opal® Bond™ Flow

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A comparison of the three products to determine substantial equivalence:

| Product | 510(k) number | Classification name | Indications for Use |
|--------------|---------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Opal Bond MV | New | Adhesive, Bracket and Tooth Conditioner | Light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel. |
| Opal Bond | K071055 | Adhesive, Bracket and Tooth Conditioner | ...This system is a bondable device for fixed attached orthodontics |
| Transbond | K073698 | Adhesive, Bracket and Tooth Conditioner | Transbond XT Light Cure Orthodontic Adhesive is designed for bonding ceramic and metal orthodontic brackets |

### Indications for Use

Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.

#### 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 (K073697).

- a. Shear Peel
- b. Flexural Strength
- c. Hardness
- d. Shear Bond with bracket
- e. Compressives
- f. Metal Shear
- g. Depth of Cure
- h. Tensile Pull (Ibf)
- i. Ambient Light Sensitivity
- j. Clinic
- k. Lab

#### Clinical Summary

A detailed Clinical Summary is included in this submission. It contains literature which we have selected that supports our claims for the safety and efficacy of Opal® Bond MV.

Opal Orthodontics

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

Ultradent Products, Incorporated C/O Ms. Diane Rogers Regulatory Affairs Manager Opal Orthodontics 505 West 10200 South South Jordan, Utah 84095

MAR 2 3 2010

Re: K094006

Trade/Device Name: Opal® Bond MV Regulation Number: 21CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: December 24, 2010 Received: December 28, 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

510(k) Number (if known): K094006

Opal® Bond MV Device Name:

Indications for Use:

Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.

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)

KSBetz DDS for Dr. K.P. Mulbry
(Division Sign-Off)

Division of Anesthesiology, General F Infection Control, Dental Devic

510(k) Number: K094006 Page_

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(Posted November 13, 2003)