ULTRAEZ DESENSITIZING GEL

K061438 · Ultradent Products, Inc. · LBH · Jun 12, 2007 · Dental

Device Facts

• Record ID: K061438
• Device Name: ULTRAEZ DESENSITIZING GEL
• Applicant: Ultradent Products, Inc.
• Product Code: LBH · Dental
• Decision Date: Jun 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

Device Story

UltraEZ Desensitizing Gel is a topical dental varnish containing potassium nitrate and fluoride ions. It functions by creating an immediate physical blockage of dentinal tubules to eliminate painful sensitivity. The gel is applied to sensitive teeth either by a dental professional in a clinical setting or by the patient at home using a custom-fabricated dental tray. The product provides a film-like barrier over exposed dentin areas. It is intended to alleviate discomfort associated with dentin hypersensitivity.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Composition: 3% potassium nitrate and 0.11% w/w fluoride ion gel. Form factor: Film-like varnish. Delivery: Custom-fabricated dental tray. Mechanism: Physical blockage of dentinal tubules.

Indications for Use

Indicated for patients experiencing dentin sensitivity, including post-operative sensitivity or sensitivity due to exposed dentin. Used by dental professionals or patients for home treatment.

Regulatory Classification

Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Predicate Devices

• Cosmedent Tooth Desensitizer
• Protect (Sunstar Butler)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo consists of a stylized "U" shape on the left, followed by the word "ULTRADENT" in bold, uppercase letters. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, thinner font. The overall design is simple and professional, conveying a sense of reliability and innovation.

K061438

# SUMMARY REPORT AND STATEMENT OF COMPARISON

# INTRODUCTION:

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 and supports the conclusion of SE for UltraEZ Desensitizing Gel noted below.

## 1. Applicant's Name and Address:

Ultradent Products, Inc. 505 West 10200 South South Jordan, Utah 84095 Telephone number: 801-553-4323 Fax number: 801-572-0600 Contact Person: Tammy Lavery Regulatory Affairs Senior Manager

### Device Information: 2.

| Classification: | Class II |
|-----------------------|---------------------------|
| Regulation: | 872.3260 |
| Trade Name: | UltraEZ Desensitizing Gel |
| Common Name: | Tooth Desensitizer |
| Classification Name: | Varnish, Cavity |
| Classification Code: | LBH |
| Classification Panel: | Dental |

### 3. Indications for Use:

The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

#### 4. Predicate Device Description & Statement of Comparison to Predicate Device:

UltraEZ Desensitizing Gel which is to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, Utah 84095, is substantially equivalent to the legally - marketed device(s): Cosmedent Tooth Desensitizer marketed by Cosmedent, Inc., 401 N. Michegan Avenue, Ste 2500, Chicago, IL 60611, and Protect marketed by Sunstar Butler Refer, 4635 West Foster Avenue, Chicago, IL 60630. Refer to the comparison table below.

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Image /page/1/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo features a stylized "U" and "E" combined into a single graphic on the left. To the right of the graphic is the word "ULTRADENT" in bold, sans-serif font. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, sans-serif font.

## Product Description Similarities:

| UltraEZ Desensitizing Gel | Cosmedent Desensitizing Gel | Protect Desensitizing Gel |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Composed of potassium nitrate<br>and fluoride ions in a film-like<br>varnish. | Composed of potassium nitrate<br>and fluoride ions in a film-like<br>varnish. | Composed of potassium and<br>fluoride ions in a film-like varnish. |
| 3% Potassium Nitrate and 0.11%<br>w/w Fluoride Ion Gel for the<br>treatment of dentin sensitivity. | 3% Potassium Nitrate and 1200<br>ppm Fluoride Ion Gel for the<br>treatment of dentin sensitivity. | Ingredients: Ethanol, water,<br>hydroxypropylcellulose, potassium<br>fluoride, polyethylene glycol,<br>dimethacrylate, methacrylates. |
| For professional dental use. | For professional dental use. | For professional dental use. |
| Immediate physical blockage of<br>dentinal tubules to eliminate<br>painful sensitivity. | Immediate physical blockage of<br>dentinal tubules to eliminate<br>painful sensitivity. | Immediate physical blockage of<br>dentinal tubules to eliminate<br>painful sensitivity. |

# Product Description Differences:

| UltraEZ Desensitizing Gel | Cosmedent Desensitizing Gel | Protect Desensitizing Gel |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------|
| Designed to be used in a custom-<br>fabricated dental tray. | Designed to be tray delivered or<br>may be brushed directly on the<br>affected area: | Designed to be brushed directly on<br>the affected area. |

# CONCLUSION:

Ultradent deems the UltraEZ Desensitizing Gel to be substantially equivalent and equally safe and effective as that of the predicates: Cosmedent's Tooth Desensitizer and Sunstar Butler's Protect Tooth Desensitizer per comparison noted above.

Tammy Lavery

Tammy Laver Regulatory Affairs Senior Manager Submitter and Contact 800 552-5512 extension 4323 or direct 801 553-4323 fax [phone] or 801 572-0600 email: [e-mail]

Aug 7, 2006
Date

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tammy Lavery Regulatory Affairs Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

JUN 1 2 2007

Re: K061438

Trade/Device Name: UltraEZ Desensitizing Gel Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 8, 2007 Received: June 11, 2007

Dear Ms. Lavery:

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. Lavery

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 [phone]. 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 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/cdrh/industry/support/index.html.

Sincerely yours.

Susan Gunner

O Chiu Lin, Ph.D. 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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# INDICATIONS FOR USE

## 510(k) Number (if known): Unknown

Device Name: UltraEZ Desensitizing Gel

Indications for use:

The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X (Per 21 CFR 801.109)

OR

Over-The-Counter Use:_

(Optional Format 1-2-96)

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