(132 days)
No
The device description and performance studies focus on a chemical desensitizing agent and usability, with no mention of AI or ML.
Yes
The device is intended for use as a tooth desensitizer, which by blocking tubules to stop signals from hot or cold food reaching dental nerves and providing a rapid remedy for hypersensitivity, acts therapeutically on the body.
No
This device is a tooth desensitizer, which treats the symptom of tooth hypersensitivity by blocking tubules in the teeth. It does not diagnose any condition.
No
The device description explicitly lists physical components such as a pre-formed dental tray, foam strips impregnated with chemicals, and plastic packaging. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a tooth desensitizer." This is a therapeutic or treatment purpose, not a diagnostic one.
- Mechanism of Action: The device works by physically blocking tubules in the teeth to reduce sensitivity. This is a direct physical effect on the body, not an in vitro test performed on a sample taken from the body.
- Device Description: The description details a physical device (tray, foam strips) and its components, which are applied directly to the teeth.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Remesense for Sensitive Teeth is intended for use as a tooth desensitizer.
Product codes
LBH
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
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.
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
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
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)
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 study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
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)
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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