(87 days)
No
The device description and performance studies focus on the chemical and physical mechanisms of action of the mouthrinse, with no mention of AI or ML.
Yes
The device is described as "relieves tooth sensitivity" by "physically occluding dentinal tubules, preventing hydrodynamic flow, thereby preventing the painful stimulation of nerves within the tooth," which indicates a therapeutic effect for a medical condition.
No
The device is described as relieving tooth sensitivity by physically occluding dentinal tubules, which is a therapeutic action, not a diagnostic one. It treats a condition rather than identifying or characterizing it.
No
The device description clearly states it is a "formulated device containing Dipotassium oxalate" and is a "Mouthrinse," indicating it is a chemical formulation, 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 to "Relieve tooth sensitivity." This is a therapeutic or preventative action taken directly on the patient's body (oral cavity), not a diagnostic test performed on a sample taken from the body.
- Mechanism of Action: The device works by physically occluding dentinal tubules within the tooth, which is a direct physical interaction with the patient's anatomy.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, measure a substance in a sample, or provide information for diagnostic purposes.
- Over-the-Counter Use: IVDs are typically used in a clinical or laboratory setting, not for over-the-counter home use for direct treatment.
While the device description mentions "Bench Performance Testing (in-vitro)," this refers to testing performed on the device itself or on samples outside of a diagnostic context to evaluate its physical properties and mechanism of action, not a diagnostic test performed on a patient sample.
N/A
Intended Use / Indications for Use
Relieves tooth sensitivity.
Provides continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact. For over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Listerine® Sensitivity Defense™ Mouthrinse (LSDM) is a formulated device containing Dipotassium oxalate directed for twice-daily use to provide continual dentinal sensitivity relief. The oxalate formula relieves this painful tooth sensitivity by physically occluding dentinal tubules, preventing hydrodynamic flow, thereby preventing the painful stimulation of nerves within the tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / Dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use / Over-the-counter use
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing: The biocompatibility evaluation for the LSDM device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standards (ISO) ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," and ISO-7405:2008 - Dentistry - Preclinical evaluation and biocompatibility of medical devices used in dentistry, as recognized by the FDA.
Biocompatibility results indicate that all components in the LSDM device comply with the ISO standards:
- ISO-10993-10:2010 Maximization Test for Delayed-Type Hypersensitivity -
- ISO-10993-10:2010 Oral Mucosa Irritation Test -
- ISO-10993-5:2009 Cytotoxicity -
Bench Performance Testing: The LSDM device was tested in in-vitro, using recognized methods for dentin occlusion including scanning electron micrographs. Hydraulic conductance testing of the subject device using Dentin Permeability model demonstrated physical occlusion of dentin tubules compared to similar device controls based on various occlusion technologies.
Clinical Performance Testing: A multi-center, double-blind, randomized, parallel-group study, controlled clinical study was conducted to determine the safety and effectiveness for the LSDM device in reducing and controlling dentinal hypersensitivity.
375 subjects were evaluated with 186 in the placebo group and 189 in the test product group. The subjects had at least two teeth that satisfied the qualifying response to stimuli for sensitivity measures (air blast and tactile). Evaluations occurred at baseline, 2 and 4 weeks. Results indicated that the test product group provided a statistically significant improvement relative to the placebo group for all primary and secondary measures at 2 and 4 weeks. In summary, in this study, the LSDM device was demonstrated to be superior to the placebo group in both the primary and the key secondary efficacy endpoints.
During the study, 7 of the subjects in the test group and 8 in the placebo control group experienced self-limiting adverse events which all resolved. All of the adverse events considered related to the test product group were mild to moderate and resolved without treatment or a change in study product usage. These were not unexpected adverse events for an oral rinse product. There were no serious adverse events during the study.
The results of the study conclude that the LSDM device showed statistically significant reductions in hypersensitivity at 2 and 4 weeks with twice-daily use supporting device effectiveness. All mild to moderate adverse events in the study groups resolved without treatment or change in study product usage and no serious adverse events were observed.
Summary: This study demonstrated that the LSDM device used twice daily as an adjunct to toothbrushing provided significantly greater efficacy in reducing and controlling dentinal hypersensitivity compared to a placebo mouth rinse. There were no serious adverse events during the study and the LSDM device was well tolerated. The LSDM device has been tested in non-clinical and clinical testing and has been shown to be safe and effective for its intended use.
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/DEN 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/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2015
Johnson & Johnson Healthcare Products Division of McNeil-PPC, Inc. C/O Ms. Angelina M. Hunt, RAC Director, Regulatory Affairs 199 Grandview Road Skillman, New Jersey 08558
Re: K143155
Trade/Device Name: Listerine® Sensitivity Defense™ Mouthwash Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: II Product Code: LBH Dated: October 31, 2014 Received: November 3, 2014
Dear Ms. Hunt:
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.
1
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/Resourcesfor You/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,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number, if known: K143155 Device Name: Listerine® Sensitivity Defense Mouthrinse
Indications for Use:
Provides continual relief from tooth sensitivity due to cold, heat, acids, sweets, or contact. Over-the-counter use.
Prescription Use OR Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
SECTION 5 - 510(k) SUMMARY
I. Submitter Information
| Name: | Johnson & Johnson Healthcare Products
Division of McNeil-PPC, Inc. |
|----------|-----------------------------------------------------------------------|
| Address: | 199 Grandview Rd.
Skillman, NJ 08558 |
| Contact: | Angelina M. Hunt, RAC |
|---|---|
| Phone: | (908) 874-2943 |
| Facsimile: | (908) 904-3712 |
| Email: | ahunt2@its.jnj.com |
Date Prepared: October 30, 2014
II. DEVICE
| Name of Device: | Listerine® Sensitivity Defense™ Mouthrinse |
|---|---|
| Common or Usual Name: | Mouthwash / Oral Rinse |
| 510(k) Number: | K143155 |
| Regulatory Class: | II |
| Classification Name: | Cavity Varnish (21 CFR 872.3260) |
| Product Code: | LBH |
III. PREDICATE DEVICE
| Predicate Device: | Colgate® Desensitizing Mouthwash | ||
|---|---|---|---|
| 510(k) Number: | K140481 | ||
| Applicant: | Colgate-Palmolive Company | ||
| Predicate Device: | Oralief™ OTC Toothpaste for Sensitive Teeth | ||
| 510(k) Number: | K080228 | ||
| Applicant: | NovaMin Technology, Inc. |
To our knowledge, the predicate devices have not been subject to a design-related recall.
| Reference Device: | Crest® Sensi-Stop Sensitivity Relief Strips (Sylphar
Remesense) |
|-------------------|--------------------------------------------------------------------|
| 510(k) Number: | K132426 |
COMPANY CONFIDENTIAL
4
Applicant:
Sylphar N.V.
To our knowledge, the reference device has not been subject to a design-related recall.
IV. Device Description
Listerine® Sensitivity Defense™ Mouthrinse (LSDM) is a formulated device containing Dipotassium oxalate directed for twice-daily use to provide continual dentinal sensitivity relief. The oxalate formula relieves this painful tooth sensitivity by physically occluding dentinal tubules, preventing hydrodynamic flow, thereby preventing the painful stimulation of nerves within the tooth.
V. INDICATIONS FOR USE
Intended Use: Relieves tooth sensitivity.
Indications for Use: Provides continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact. For over-the-counter use.
The Indications for Use statement for the LSDM is the same as the listed predicate devices. They are generally all indicated for providing relief from tooth sensitivity due to cold, heat, acids, sweets or contact. Additionally, the subject device and predicate devices are available over-the-counter for home use and have the same intended use for the relief of tooth sensitivity.
VI. COMPARISON OF TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The intended use, oral application and fundamental technology of the Listerine Sensitivity Defense Mouthrinse device is substantially equivalent to the predicate devices, Colgate Desensitizing Mouthwash and Oralief toothpaste for Sensitive Teeth. These devices contain a formulated occlusion technology that blocks the hydrodynamic flow within the open tubules. Open dentin tubules allow the fluid to transmit external stimuli to the nerves within the dentin pulp and to trigger a pain response, resulting in dentinal hypersensitivity. The components in the LSDM device 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 the pain response. The physical mechanism of action is responsible for the product's ability to achieve its intended purpose.
Technological characteristics differ in each formula composition between the subject device and the predicates; however, the fundamental scientific technology responsible for how the device achieves its intended use is the same.
5
| Device | Classification
Name | Intended
Use | Technical
Composition/
Occluding
Component | Fundamental
Technology /
Mechanism
of Action | Usage
Form |
|---------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------|-------------------------------|
| Listerine®
Sensitivity
Defense™
Mouthrinse
(LSDM)
(K143155) | Cavity
Varnish | Relief
from tooth
sensitivity | Dipotassium
Oxalate | Occlusion of
dentinal
tubules | Mouthwash/
Oral rinse |
| Predicate
Colgate®
Desensitizing
Mouthwash
(K140481) | Cavity
Varnish | Relief
from tooth
sensitivity | Arginine | Occlusion of
dentinal
tubules | Mouthwash/
Oral rinse |
| Predicate
Oralief™ OTC
Toothpaste for
Sensitive Teeth
(K080228) | Cavity
Varnish | Relief
from tooth
sensitivity | Calcium
sodium
phosphosilicate
(Novamin
Technology) | Occlusion of
dentinal
tubules | Non-
aqueous
Toothpaste |
| Reference
Device
Crest® Sensi-
Stop
Sensitivity
Relief Strips
(Sylphar
Remesense)
(K132426) | Cavity
Varnish | Relief
from tooth
sensitivity | Oxalic Acid,
Potassium Salt | Occlusion of
dentinal
tubules | Gel strips |
Table1: Intended Use and Technical Characteristic Comparison
6
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the LSDM device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standards (ISO) ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," and ISO-7405:2008 - Dentistry - Preclinical evaluation and biocompatibility of medical devices used in dentistry, as recognized by the FDA.
Biocompatibility results indicate that all components in the LSDM device comply with the ISO standards:
- ISO-10993-10:2010 Maximization Test for Delayed-Type Hypersensitivity -
- ISO-10993-10:2010 Oral Mucosa Irritation Test -
- ISO-10993-5:2009 Cytotoxicity -
Bench Performance Testing
The LSDM device was tested in in-vitro, using recognized methods for dentin occlusion including scanning electron micrographs. Hydraulic conductance testing of the subject device using Dentin Permeability model demonstrated physical occlusion of dentin tubules compared to similar device controls based on various occlusion technologies.
Clinical Performance Testing
A multi-center, double-blind, randomized, parallel-group study, controlled clinical study was conducted to determine the safety and effectiveness for the LSDM device in reducing and controlling dentinal hypersensitivity.
375 subjects were evaluated with 186 in the placebo group and 189 in the test product group. The subjects had at least two teeth that satisfied the qualifying response to stimuli for sensitivity measures (air blast and tactile). Evaluations occurred at baseline, 2 and 4 weeks. Results indicated that the test product group provided a statistically significant improvement relative to the placebo group for all primary and secondary measures at 2 and 4 weeks. In summary, in this study, the LSDM device was demonstrated to be superior to the placebo group in both the primary and the key secondary efficacy endpoints.
During the study, 7 of the subjects in the test group and 8 in the placebo control group experienced self-limiting adverse events which all resolved. All of the adverse events considered related to the test product group were mild to moderate and resolved without treatment or a change in study product usage. These were not unexpected adverse events for an oral rinse product. There were no serious adverse events during the study.
COMPANY CONFIDENTIAL
7
The results of the study conclude that the LSDM device showed statistically significant reductions in hypersensitivity at 2 and 4 weeks with twice-daily use supporting device effectiveness. All mild to moderate adverse events in the study groups resolved without treatment or change in study product usage and no serious adverse events were observed.
Summary
This study demonstrated that the LSDM device used twice daily as an adjunct to toothbrushing provided significantly greater efficacy in reducing and controlling dentinal hypersensitivity compared to a placebo mouth rinse. There were no serious adverse events during the study and the LSDM device was well tolerated. The LSDM device has been tested in non-clinical and clinical testing and has been shown to be safe and effective for its intended use.
VII. Conclusion
Based on the results of non-clinical and clinical testing on the LSDM device, the mouthrinse device is at least as safe and effective as the predicate devices through toxicological safety assessments, stability and in-vitro and clinical performance testing, therefore supporting that the LSDM device meets its intended use and is substantially equivalent to the predicate devices.