(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.
§ 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.