COLGATE DESENSITIZING DENTAL CREAM

K103461 · Colgate-Palmolive Co. · LBH · Sep 13, 2011 · Dental

Device Facts

• Record ID: K103461
• Device Name: COLGATE DESENSITIZING DENTAL CREAM
• Applicant: Colgate-Palmolive Co.
• Product Code: LBH · Dental
• Decision Date: Sep 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

For the management of sensitive teeth. Provides rapid relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Rapid Desensitizer

Device Story

Colgate® Desensitizing Dental Cream is a topical dental cream designed for the management of dentin hypersensitivity. The device functions via a physical mechanism of action: components adhere to exposed dentin tubules, forming a solid plug that prevents fluid movement within the tubules and blocks external stimuli from reaching the nerves in the dentin pulp. It is intended for over-the-counter use by patients to provide rapid relief from tooth sensitivity. The device is applied directly to the affected area. Clinical benefit includes immediate reduction of pain response to thermal, chemical, or tactile stimuli. This submission represents an Rx-to-OTC switch for a previously cleared prescription device.

Clinical Evidence

Clinical studies demonstrate that direct application of the device provides instant sensitivity relief. In vitro studies confirm physical occlusion of dentin tubules, creating a protective barrier against external stimuli. No specific sample sizes or statistical metrics (p-values, CIs) were provided in the summary.

Technological Characteristics

Physical occlusion of dentin tubules via topical cream application. Complies with ISO 11609 (toothpaste requirements), ISO 10993-1 (biological evaluation), and ISO 7405 (biocompatibility of dental materials).

Indications for Use

Indicated for management of sensitive teeth in patients experiencing pain from cold, heat, acids, sweets, or contact.

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

• DenClude® Desensitizing Dental Cream (K003482)
• ProClude® Prophylaxis Paste (K002989)
• Oravive™ Tooth Revitalizing Paste (K040473)
• Protect™ Tooth Desensitizer (K050486)

Submission Summary (Full Text)

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K103461 SEP 13 201

Colgate-Palmolive Company Colgate® Desensitizing Dental Cream Rx to OTC switch Traditional 510(k) Notification

#### 510(k) Summary 8.

This 510(k) summary is in accordance with the requirements of 21 CFR 807.92(c).

November 23, 2010 Submission Date:

510 (k) Notification: Traditional 510(k) Submission

#### Submitter Information:

| Company: | Colgate-Palmolive Company |
|------------|--------------------------------------------------------------------------|
| Address: | 909 River Road<br>Piscataway, NJ 08855 USA |
| Contact: | Charles P. Ireland, MBA<br>Director of Regulatory Affairs, North America |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Email: | |

#### Device Information:

| Establishment Registration number: | 2418748 |
|------------------------------------|-------------------------------------|
| Common Device: | Dentifrice, Toothpaste |
| Trade Name: | Colgate® Desensitizing Dental Cream |
| Classification Name: | Varnish, Cavity; 21 CFR § 872.3260 |
| Classification Product Code: | LBH |
| Classification Panel: | Dental |
| Class: | II |

#### Intended Use:

For the management of sensitive teeth. Provides rapid relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Rapid Desensitizer

Reason for the 510(k): This premarket notification (510(k)) submission is intended to modify the marketing status of our legally marketed device, Rx home-use DenClude (originally called ProClude-Sensitive) Desensitizing Cream (K003482) from Prescription use to Over-the-counter use. All of the components for Colgate® Desensitizing Dental Cream (CDDC) are similar to the previously cleared DenClude Desensitizing Cream. These intended use are consistent with the indications cleared in the DenClude 510(k).

### Predicate Devices used to claim substantial equivalence to:

Colgate Desensitizing Dental Cream has the same intended use and utilizes the same technological characteristics as these legally marketed predicate devices. The components of CDDC have previously been cleared by CDRH in dental devices, including Colgate-

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#### Colgate-Palmolive Company Colgate® Desensitizing Dental Cream Rx to OTC switch Traditional 510(k) Notification

K103461

Palmolive's ProClude® (K002989) and DenClude® (K003482) and the other predicate devices.

| 1. | Trade Name: | DenClude® Desensitizing Dental Cream |
|----|----------------|--------------------------------------|
| | Owner: | Colgate-Palmolive Company |
| | Original name: | ProClude-Sensitive |
| | 510(k) number: | K003482 |
| | Product Code: | LBH |
| 2. | Trade Name: | ProClude® Prophylaxis Paste |
| | Owner: | Colgate-Palmolive Company |
| | 510(k) number: | K002989 |
| | Product Code: | EJR |
| 3. | Trade Name: | Oravive™ Tooth Revitalizing Paste |
| | Applicant: | NovaMin Technology, Inc |
| | 510(k) number: | K040473 |
| | Product Code: | LBH |
| 4. | Trade Name: | Protect™ Tooth Desensitizer |
| | Applicant: | Sunstar Butler |
| | 510(k) number: | K050486 |
| | Product Code: | LBH |

# Technological Characteristics

The general components, intended use and application of CDDC are substantially equivalent to those of the legally marketed predicate devices. Open dentin tubules allow the fluid within to transmit external stimuli to the nerves within the dentin pulp and to trigger a pain response, resulting in dentin hypersensitivity. The components of CDDC physically adhere to exposed dentin forming a solid plug, stopping fluid movement. This physical mechanism of action is responsible for the product's ability to achieve its intended purpose.

# Performance Data

In vitro studies show that CDDC demonstrates physical occlusion of the dentin tubules, creating a protective barrier that prevents external stimuli from reaching the nerves that reside in the dentin pulp. Clinical studies show that instant sensitivity relief occurs with direct application..

The conclusions drawn from the performance testing are that the device is safe and as effective as the predicate devices. Furthermore, the device performs its intended use as well as or better than the legally marketed predicate devices and complies with several ISO standards.

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K103461

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# Performance Standards

CDDC complies with the following ISO standards:

- ISO 11609, Dentistry Toothpastes Requirements, test methods and marking, u 1998.
- ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: I Evaluation and testing.
- . ISO 7405: 2008 (E), Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Charles P. Ireland Director of Regulatory Affairs, North America Colgate-Palmolive Company 909 River Road Piscataway, New Jersey 08855

SEP 1 3 2011

Re: K103461

Trade/Device Name: Colgate® Desensitizing Dental Cream Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: September 8, 2011 Received: September 9, 2011

Dear Mr. Ireland:

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 ffor 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 - Mr. Ireland

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 /ucm11.5809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh 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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K103461

Colgate-Palmolive Company Colgate® Desensitizing Dental Cream Rx to OTC switch Traditional 510(k) Notification

7. Indications for Use

510(k) Number (if known): _ KJO3 Y o

Device Name: Colgate® Desensitizing Dental Cream

# Indications for Use:

For the management of sensitive teeth.

Provides rapid relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact.

· Rapid Desensitizer

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (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)

Susan Purro

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

510(k) Number: K103461