(99 days)
For the management of sensitive teeth. Provides relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Desensitizes teeth for lasting relief.
Colgate® Desensitizing Mouthwash (CDMW) is an oral rinse. The components of CDMW physically form a thin film that acts like a seal, thereby physically restricting fluid movement through the dentin tubules and preventing external stimuli from triggering a pain response.
This document, K140481, describes the submission for Colgate® Desensitizing Mouthwash (CDMW). The primary study proving the device meets its acceptance criteria is an in-vitro hydraulic conductance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reduction of dentinal fluid flow (seal formation) for management of sensitive teeth. | "Hydraulic conductance in-vitro study shows that Colgate® Desensitizing Mouthwash (referred to as Colgate® Sensitive Pro-Relief Mouthwash in the report) block dentinal fluid flow by forming a thin film that acts like a seal resulting in the reduction of fluid flow ultimately associated with decrease dentinal hypersensitivity." |
| Compliance with ISO standards | "CDMW complies with the following ISO standards: ISO 16408:2004, ISO 10993-1:2003 (E), ISO 7405: 2008 (E)." |
| Safety and Effectiveness | "The conclusions drawn from the performance testing are that the device is safe and as effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the in-vitro hydraulic conductance study. It is an in-vitro study, meaning it was conducted in a controlled environment outside of a living organism. Therefore, terms like "country of origin of the data" or "retrospective or prospective" are not applicable in the same way they would be for human clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Given it's an in-vitro study, expert involvement would likely be in the design and interpretation of the experiment, rather than establishing "ground truth" for a test set in the clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is in-vitro and does not involve human readers interpreting results that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The described study is an in-vitro hydraulic conductance study, not a human reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a mouthwash, not an algorithm or a software device. The described study evaluates the physical mechanism of action of the mouthwash.
7. The Type of Ground Truth Used
For the in-vitro hydraulic conductance study, the "ground truth" would be the objective measurement of dentinal fluid flow and the physical observation of film formation and sealing within the controlled laboratory setting. It is based on direct measurement and physical observation of the product's mechanism of action.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI-based device that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device and study.
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Image /page/0/Picture/0 description: The image shows the logo for Colgate-Palmolive. The logo consists of the letters "CP" in a stylized font on the left, followed by the words "COLGATE-PALMOLIVE" in a bold, sans-serif font. The letters and words are all in black, and the background is white. The logo is simple and recognizable.
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) Number: K140481
| Submission Date: | February 20, 2014. |
|---|---|
| 510 (k) Notification: | Special 510(k) submission |
Submitter Information:
| Company: | Colgate-Palmolive Company |
|---|---|
| Address: | 909 River Road |
| Piscataway, NJ 08855 USA | |
| Contact: | Charles P. Ireland, MBA |
| Director of Regulatory Affairs, North America | |
| Telephone: | (732) 878-7519 |
| Telefax: | (732) 878-7135 |
| Email: | Charles Ireland@colpal.com |
| Date Prepared: | June 2, 2014 |
Device Information:
Establishment Registration number: Common Device:
Classification Name: Classification Product Code: Classification Panel: Class:
2418748 Mouthwash, Oral rinse Colgate® Desensitizing Mouthwash Varnish, Cavity; 21 CFR § 872.3260 LBH Dental I I
Indications for Use:
For the management of sensitive teeth. Provides relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Desensitizes teeth for lasting relief.
Reason for the 510(k): This special premarket notification (Special 510(k)) submission is intended to modify the dosage form of our cleared medical device Colgate® Desensitizing Dental Cream (CDDC) from dentifrice to oral rinse. The components for Colgate® Desensitizing Mouthwash (CDMW) are similar to the previously cleared CDDC, and are commonly used in OTC oral care products. There is no change to the intended use of CDMW and it relies on the same fundamental scientific technology to function. The indications are consistent with the indications cleared in the CDDC 510(k).
Predicate Device used to claim substantial equivalence to:
CDMW has the same intended use and utilizes the same technological characteristics of CDDC our cleared predicate device. The components of CDMW have previously been cleared by CDRH in dental devices, including Colgate® Desensitizing Dental Cream (K103461). The technological characteristics of CDMW differ from CDDC but the fundamental scientific technology is the same.
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Image /page/1/Picture/0 description: The image shows the logo for Colgate-Palmolive. On the left is a stylized "CP" in a bold, sans-serif font. To the right of the logo is the text "COLGATE-PALMOLIVE" in a bold, sans-serif font.
| Trade Name: | Colgate® Desensitizing Dental Cream |
|---|---|
| Owner: | Colgate-Palmolive Company |
| 510(k) number: | K103461 |
| Product Code: | LBH |
Technological Characteristics:
The general components, intended use and application of Colgate® Desensitizing Mouthwash (CDMW) are substantially equivalent to our predicate device CDDC. 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 CDMW physically form a thin film that acts like a seal, thereby physically restricting fluid movement through the dentin tubules and preventing external stimuli from triggering a pain response. This physical mechanism of action is responsible for the product's ability to achieve its intended purpose.
Performance Data:
Hydraulic conductance in-vitro study shows that Colgate® Desensitizing Mouthwash (referred to as Colgate® Sensitive Pro-Relief Mouthwash in the report) block dentinal fluid flow by forming a thin film that acts like a seal resulting in the reduction of fluid flow ultimately associated with decrease dentinal hypersensitivity.
The conclusions drawn from the performance testing are that the device is safe and as effective as the predicate device. Furthermore, the device performs its intended use as well as the cleared predicate device and complies with several ISO standards.
Performance Standards:
CDMW complies with the following ISO standards:
- . ISO 16408:2004, Dentistry- Oral hygiene products-Oral rinses, 2004.
- ISO 10993-1:2003 (E), Biological evaluation of medical devices Part 1 Evaluation and . testing within a risk management process, 2009.
- ISO 7405: 2008 (E), Dentistry Evaluation of biocompatibility of medical devices used in . dentistry, 2008.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI> 20993-0002
June 5, 2014
Colgate-Palmolive Company Mr. Charles Ireland, MBA Director, Regulatory Affairs, North America 909 River Road, Post Office Box 1343 Piscataway, NJ 08855
Re: K140481
Trade/Device Name: Colgate Desensitizing Mouth Wash Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: May 21, 2014 Received: May 22, 2014
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 (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 - 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S: Bupper -S
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
\
510(k) Number (if known) K140481 .
Device Name
Colgate® Desensitizing Mouthwash
Indications for Use (Describe) For the management of sensitive teeth. Provides relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Desensitizes teeth for lasting relief
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line - continue on a separate page if needed.
CONTRACTORIAL CONFORT FOR FOR FOR FOR FOR FOR FOR MANAGEM OF THE CORPORATION OF THE CORPORATION OF
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sheena A. Green -S 2014.06.05 15:11:01 -04
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§ 872.3260 Cavity varnish.
(a)
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.(b)
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.