'Sylphar Remesense for Sensitive Teeth' is an identical device to 'Remedent Remesense', cleared for marketing in the US by FDA under K082594. 'Remedent Remesense' was cleared as a 'prescription only' (Rx) device. The purpose of this 510(k) submission is to present additional data so that 'Sylphar Remesense for Sensitive Teeth' may be cleared by FDA for marketing as an 'over-the-counter' (OTC) device in addition to a prescription device under a new name. The labeling, both on the device box and in the instructions sheet provided in the box, has however been revised to include the new product name and provide additional information to better accommodate sale as an OTC device. The component parts of the device are: Outer box, Pre-formed dental tray in a plastic bag, 3 x Two foam strips impregnated with glycerin, aqua, dipotassium oxalate, aroma, EDTA, methylparaben, citric acid and saccharin, Plastic packaging for the foam strips, with foil covering, Instruction sheet. Sylphar Remesense for Sensitive Teeth uses dipotassium oxalate crystals to block the tubules in the teeth of patients suffering from acute tooth hypersensitivity. By blocking the tubules, it stops the signals from hot or cold food reaching the dental nerve, providing a rapid remedy for hypersensitivity.

AI/ML Overview

The provided document for Sylphar Remesense for Sensitive Teeth describes a 510(k) submission to clear the device for over-the-counter (OTC) use, building upon a previous clearance for prescription-only use. The submission focuses on comparing the device to predicate devices and addressing suitability for OTC marketing rather than establishing new performance criteria through a traditional clinical study with defined acceptance criteria and statistical endpoints.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly available in the provided document. The submission is focused on demonstrating substantial equivalence to predicate devices and suitability for OTC labeling, rather than meeting specific performance criteria like a new device validation study would entail.

2. Sample Size Used for the Test Set and Data Provenance

Test Set: Not applicable in the traditional sense of a clinical trial test set for device performance. The two "studies" performed were:
- A questionnaire sent to US dentists. The sample size for this is not provided.
- A usability study of the subject device. The sample size for this is not provided.
Data Provenance:
- Questionnaire: US dentists (prospective, as it was sent out).
- Usability Study: The location of the usability study is not specified, and it's unclear if it was prospective or retrospective, though usability studies are typically prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the "studies" conducted were not designed to establish a "ground truth" in the manner of diagnostic or treatment efficacy studies.

The questionnaire gathered input from "US dentists." Their specific qualifications beyond being dentists are not detailed.
The usability study involved "patients suffering from tooth hypersensitivity," not experts establishing ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the "studies" were not designed to establish a "ground truth" requiring adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted. The studies focused on dentist perception and patient usability for an OTC product, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical product (tooth desensitizer), not an algorithm or software.

7. The Type of Ground Truth Used

There was no "ground truth" used in the context of clinical efficacy or diagnostic accuracy, as this was not the purpose of the submitted "performance data." The "questionnaire" aimed to understand dentist prescribing habits and information needs for OTC products, and the "usability study" aimed to assess patient's ability to select and understand the product for OTC use.

8. The Sample Size for the Training Set

This is not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for this type of device.

Summary of the Document's Approach to Acceptance Criteria:

The document describes a submission seeking OTC clearance for a tooth desensitizer. Instead of presenting a new clinical trial with pre-defined performance acceptance criteria (e.g., a specific reduction in pain score over a certain period), the submission relies on:

Substantial Equivalence: Primarily, the device is considered "identical" to a previously cleared prescription device (Remedent Remesense, K082594) and is compared to other predicate devices (Centrix Senzzzz Aqua, K120176). The core argument is that the device itself has already been proven safe and effective for its intended use.
Suitability for OTC Use: To justify the change from prescription to OTC, the submission presents two "studies":
- Dentist Questionnaire: The acceptance "criteria" here would likely be the satisfactory feedback from dentists indicating that they already recommend similar products for home use and that additional patient information (to be added to labeling) would suffice for OTC. The reported "performance" was that dentists "are routinely prescribing Rx tooth desensitizing products for patient home use" and that "additional information provided is merely a reinforcement of product instructions."
- Usability Study: The acceptance criteria would relate to patients' ability to understand and safely use the product in an OTC setting, including correct selection and avoiding contraindications. The reported "performance" was that "patients suffering from tooth hypersensitivity are able to select the product from a display of other dental products, and also that patients who have conditions that are contraindicated for use of the subject device are unlikely to select the product." Recommendations for labeling improvements were also made.

In essence, the "acceptance criteria" were less about the clinical efficacy of the device (which was established via its predicate) and more about demonstrating that the device could be safely and effectively marketed and used by consumers without a prescription, with appropriate labeling adjustments.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "Sylphar" in a stylized font, with a line above it. To the left of the word is a circular logo with the letters "SP" inside. The logo and the word "Sylphar" are in a dark color, possibly black or dark blue. The image appears to be a logo or branding element for a company named Sylphar.

Type of 510(k) submission:

FDA Registration Number:

FDA Registration Number: Owner/Operator Number:

510{k} Submitter and Contact:

Date of Submission:

Appendix E

JAN 1 4 2013

510(k) Summary in accordance with 21 CFR 807.92(c)

Device Name:

Manufacturer:

510(k) Owner:

Phone:

Fax:

Sylphar Remesense for Sensitive Teeth

Traditional

30 August 2012

Sylphar N.V. Xavier de Cocklaan 42 B-9831 Deurle Belgium

3004847139

Sylphar N.V. Xavier de Cocklaan 42 B-9831 Deurle Belgium

+32 (0)9 321 70 80 +32 (0)9 321 70 90

3006673777

10034642

ાં કાર

872.2360

Dental

Class II

Varnish, Cavity

Tooth Desensitizer

Mr Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 00153 Rome Italy

Phone: +39 06 578 2665 Fax: +30 06 574 3786 Email: rgray@donawa.com

FDA Product Code: FDA Regulation Number: FDA Classification Name: Classification Panel: Common Name: FDA Panel: FDA Classification:

FDA 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.

510(k) for Sylphar Remesense for Sensitive Teeth

Appendix E

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Sylphar. The logo consists of a circular design with the letters "SF" inside, followed by the word "Sylphar" in a bold, sans-serif font. The word "Sylphar" has a line above it.

Indications for Use: Remesense for Sensitive Teeth is intended for use as a tooth desensitizer.

Device Description:

'Sylphar Remesense for Sensitive Teeth' is an identical device to 'Remedent Remesense', cleared for marketing in the US by FDA under K082594.

'Remedent Remesense' was cleared as a 'prescription only' (Rx) device. The purpose of this 510(k) submission is to present additional data so that 'Sylphar Remesense for Sensitive Teeth' may be cleared by FDA for marketing as an 'over-the-counter' (OTC) device in addition to a prescription device under a new name.

The labeling, both on the device box and in the instructions sheet provided in the box, has however been revised to include the new product name and provide additional information to better accommodate sale as an OTC device.

The component parts of the device are:

. Outer box
.
Pre-formed dental tray in a plastic bag .
- 3 x Two foam strips impregnated with glycerin, aqua, dipotassium oxalate, aroma, EDTA, methylparaben, citric acid and saccharin
Plastic packaging for the foam strips, with foil covering .
Instruction sheet .

Performance Data:

Sylphar Remesense for Sensitive Teeth uses dipotassium oxalate crystals to block the tubules in the teeth of patients suffering from acute tooth hypersensitivity. By blocking the tubules, it stops the signals from hot or cold food reaching the dental nerve, providing a rapid remedy for hypersensitivity.

in order to confirm the safety and effectiveness of Sylphar Remesense for Sensitive Teeth as an OTC product, two studies were performed:

· The first was a questionnaire sent to US dentists
· The second was a usability study of the subject device

The conclusion from the results of the questionnaire was that dentists are routinely prescribing Rx tooth desensitizing products for patient home use, and that any additional information provided is merely a reinforcement of product instructions, rather than anything new related to safety or effectiveness. The additional instructions provided by the dentists answering the questionnaire have been reviewed and, where relevant to the subject device, it has been ensured that these are included within the instructions drafted for the subject device.

The conclusion from the usability study on the subject device was that patients suffering from tooth hypersensitivity are able to select the product from a display of other dental products, and also that patients who have conditions that are contraindicated for use of the subject device are unlikely to select the product. Several recommendations for improvement of the product labeling resulted from the usability studv.

Comparison with predicate devices:

The predicate devices selected for comparison with the Sylphar Remesense for Sensitive Teeth are:

Predicate Device 1:	Remedent Remesense
510(k) Sponsor:	Remedent N.V.
510(k) Number:	K082594

510(k) for Sylphar Remesense for Sensitive Teeth

Appendix E

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "Sulphar" in a stylized font, with a line above it. To the left of the word is a circular logo with the letters "SP" inside. The logo is made up of thick lines, and the letters are stylized to fit within the circle. The image is in black and white.

Clearance Date:	19 March 2009
FDA Product Code:	LBH
Classification Name:	Varnish, Cavity
Regulation No:	872.3260
Predicate Device 2:	Centrix Senzzzz Awa
510(k) Sponsor:	Centrix Inc
510(k) Number:	K120176
Clearance Date:	25 July 2012
FDA Product Code:	LBH
Classification Name:	Varnish, Cavity
Regulation No:	872.3260

Conclusion:

Based on the information contained within this submission, it is concluded that 'Sylphar Remesense for Sensitive Teeth' is substantially equivalent to the identified predicate devices already in interstate commerce within the USA.

: . .

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The text is in all capital letters and is in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 14, 2013

Sylphar N.V. C/O Mr. Roger Gray Vice President, Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 Rome, Italy 00153

Re: K122708

Trade/Device Name: Sylphar Remesense for Sensitive Teeth Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: January 3, 2013 Received: January 11, 2013

Dear Mr. Gray:

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.

{4}------------------------------------------------

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/ucm115809.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Statement

1122708 510(k) Number (if known): Notknown

Device Name: Sylphar Remesense for Sensitive Teeth

Indications for Use:

Remesense for Sensitive Teeth is intended for use as a tooth desensitizer

Prescription Use (Part 21 CFR 801 Subpart D)

ਸੀ

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ಸ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

201	Cرا، لا، ا		T	11

Susan Runner DDS, MA 14:35:39

-05'00'

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

510(k) Number: kla 1708

Page 1 of 1 Rev.2 Apr 4, 2008

Regulation Number and Section

§ 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.