(99 days)
Not Found
No
The description focuses on the physical mechanism of action (forming a film to block tubules) and does not mention any computational or learning-based components.
Yes
The device is described as providing relief from painful sensitivity and desensitizing teeth, which are therapeutic effects for a medical condition.
No
The device description and intended use indicate it is for the management and relief of sensitive teeth by forming a physical seal, not for identifying, diagnosing, or monitoring a disease or condition. It is a therapeutic device.
No
The device description clearly states it is an "oral rinse" and describes its physical mechanism of action, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of sensitive teeth and providing relief from painful sensitivity. This is a therapeutic or preventative action directly on the patient's body (teeth).
- Device Description: The device is an oral rinse that physically forms a film on the teeth to block stimuli. This is a physical interaction with the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition. The mechanism of action is physical, not analytical.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEL number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEL number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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.
2
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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.
3
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
4
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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