(1 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of the silver diamine fluoride solution and its mechanism of action (occluding dentinal tubules). There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is used for the "Treatment of dentinal hypersensitivity" and works by physically occluding dentinal tubules, which is a therapeutic action to reduce tooth sensitivity.
No
The device, e-SDF, is described as a "single component liquid device" applied to the tooth to reduce sensitivity by physically occluding dentinal tubules. Its intended use is "Treatment of dentinal hypersensitivity," not diagnosis. The performance studies also focus on its efficacy in reducing fluid flow and occluding tubules, which are therapeutic actions.
No
The device description clearly states it is a "single component liquid device" and is "applied to the tooth using an applicator brush or similar application," indicating it is a physical substance, 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 "Treatment of dentinal hypersensitivity." This is a therapeutic treatment applied directly to the tooth to alleviate a symptom.
- Device Description: The device is a liquid applied to the tooth to physically occlude dentinal tubules. This is a physical action on the tooth structure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body, or provide information about a patient's health status. IVDs are used to perform tests on samples (like blood, urine, tissue) to provide diagnostic information.
The device's function is to treat a condition by physically altering the tooth structure, which falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Treatment of dentinal hypersensitivity For use in adults over the age of 21.
Product codes
PHR
Device Description
e-SDF is a single component liquid device made up of 38% silver diamine fluoride.Silver diamine fluoride solution is applied to the tooth, to reduce tooth sensitivity by physically occluding the open dentinal tubules. e-SDF is a liquid that is applied to the teeth using an applicator brush or similar application.
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
adults over the age of 21
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)
A Hydraulic Conductance study of e-SDF and Silver Dental Arrest (Advantage arrest) tooth desensitisers was conducted. The data demonstrated that e-SDF is an effective agent to reduce fluid flow through dentine, and is substantially equivalent to Silver Dental Arrest (Advantage arrest) in treating dentinal hypersensitivity. Scanning electron microscope (SEM) images showed both e-SDF and Advantage Arrest formed a precipitate to occlude the open dentinal tubules.
Biocompatibility testing was conducted according to ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO 7405:2018 - Dentisty -Evaluation of biocompatibility of medical devices used in dentistry, and FDA General Guidance on the Use of International Standard ISO 10993-1 (2020).
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
March 6, 2024
Kids-e-Dental LLP % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K240619 Trade/Device Name: e-SDF Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: Class II Product Code: PHR Dated: March 5, 2024 Received: March 5, 2024
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
e-SDF
Indications for Use (Describe)
Treatment of dentinal hypersensitivity For use in adults over the age of 21.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Kids-e-Dental. The logo features the text "Kids-e-Dental" in a stylized font. A golden crown is placed above the letter "e" in "Kids-e-Dental", adding a playful and child-friendly touch to the logo. The letters are black, except for the "e" which is yellow.
510(k) Summary for e-SDF
| Date Summary was Prepared | February 20th 2024 |
|---|---|
| 510(k) Submitter | kids-e-dental LLP |
| 411, Akruti Arcade, Jp Road, Opp A.H Wadia school, Andheri | |
| west, Mumbai, India400053 | |
| http://kids-e-dental.com/ | |
| +91-7506-038-332 | |
| drmukul@kids-e-dental.com | |
| Primary Contact for this | |
| 510(k)Submission | kids-e-dental LLP |
| 411, Akruti Arcade, Jp Road, Opp A.H Wadia school, Andheri | |
| west, Mumbai, India400053 | |
| http://kids-e-dental.com/ | |
| +91-7506-038-332 | |
| drmukul@kids-e-dental.com | |
| Device Common Name | Tooth Desensitizer |
| Trade Name | e-SDF |
| Device Product Codes | |
| andClassification | Class II, PHR, 21 CFR 872.3260 |
| Predicate Device | Silver Dental Arrest (Advantage arrest), K102973 |
| Device Description | e-SDF is a single component liquid device made up of 38% silver |
| diamine fluoride.Silver diamine fluoride solution is applied to the | |
| tooth, to reduce tooth sensitivity by physically occluding the open | |
| dentinal tubules. e-SDF is a liquid that is applied to the teeth | |
| using an applicator brush or similar application. | |
| Indications for Use | Treatment of dentinal hypersensitivity. |
| For use in adults over the age of 21 |
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Image /page/4/Picture/0 description: The image shows the logo for "Kids-e-Dental". The logo features the text "Kids-e-Dental" in a stylized font, with a golden crown above the "e". The crown has several points, and the "e" has a swoosh design underneath it. There is a trademark symbol in the upper right corner of the logo.
Technological Characteristics
The intended use and key technological characteristics of e-SDF are substantially equivalent to that of the Predicate Device, Silver Dental Arrest (K102973).
A detailed comparison between the Subject Device and the Predicate Device is presented in the Table below-
| Description | Subject Device
e-SDF | Predicate Device
Silver Dental Arrest (102973) | Equivalency |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Company Name | Kids-e-Dental
LLP, India | Elevate Oral Care
(named as ADP Silver Dental
Arrest, LLC in 510k), USA | NA |
| Classification
Name | Cavity Varnish | Cavity Varnish | Equivalent |
| Common Name | Tooth desensitiser | Tooth desensitiser | Equivalent |
| Indications for Use | Treatment of
dentinal
hypersensitivity.
For use in adults over
theage of 21. | Treatment of
dentinal
hypersensitivity.
For use in adults over the age
of21. | Similar |
| Classification
Product Code &
Regulation
Number | PHR, 21 CFR 872.3260 | PHR, 21 CFR 872.3260 | Similar |
| Material
composition | Silver diamine fluoride | Silver diamine fluoride | Similar |
| Mode of action | Tubule occlusion | Tubule occlusion | Similar |
| Application: | Liquid | Liquid | Similar |
| Technical method
/ characteristics: | Silver diamine fluoride
forms precipitates with
calcium or phosphate in
the dentinal tubules to
block open dentinal
tubules | Silver diamine fluoride forms
precipitates with calcium or
phosphate in the dentinal tubules
to block open dentinal tubules | Similar |
| Sterility,
Packaging | Non-Sterile, Bulk Pack | Non-Sterile, Bulk Pack | Similar |
| Description | Subject Device
e-SDF | Predicate Device
Silver Dental Arrest (K102973) | Equivalency |
| OTC/Rx | Rx | Rx | Similar |
| Biocompatibility | Biocompatible as
per ISO 10993-1 | Biocompatible as per ISO 10993-1 | Similar |
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Image /page/5/Picture/0 description: The image is a logo for "Kids-e-Dental". The logo features the text "Kids-e-Dental" in a stylized font, with a golden crown above the "e" in "Kids-e-Dental". The crown has three points, each topped with a small golden ball. The "e" in "Kids-e-Dental" is stylized with a curved line underneath it. The letters are black, and the background is white.
Non-clinical performance testing
A Hydraulic Conductance study of e-SDF and Silver Dental Arrest (Advantage arrest) tooth desensitisers was conducted. The data demonstrated that e-SDF is an effective agent to reduce fluid flow through dentine, and is substantially equivalent to Silver Dental Arrest (Advantage arrest) in treating dentinal hypersensitivity. Scanning electron microscope (SEM) images showed both e-SDF and Advantage Arrest formed a precipitate to occlude the open dentinal tubules.
Biocompatibility testing was conducted according to ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO 7405:2018 - Dentisty -Evaluation of biocompatibility of medical devices used in dentistry, and FDA General Guidance on the Use of International Standard ISO 10993-1 (2020).
Conclusion:
e-SDF is deemed substantially equivalent to the Predicate Device, Silver Dental Arrest (Advantage arrest) (K102973) due to the similarities in intended use and function. Performance testing & Biocompatibility demonstrate that e-SDF is as safe and effective as the Predicate Device. The minor technological differences between e-SDF and the Predicate Device do not raise any questions on the safety and effectiveness of the Subject Device.