(1 days)
Treatment of dentinal hypersensitivity For use in adults over the age of 21.
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.
The provided text describes a 510(k) summary for a medical device called "e-SDF." This device is a liquid made of 38% silver diamine fluoride, intended to treat dentinal hypersensitivity by occluding open dentinal tubules. The submission aims to demonstrate substantial equivalence to a predicate device, "Silver Dental Arrest (Advantage arrest)" (K102973).
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative sense with pass/fail thresholds. Instead, it presents a comparison of technological characteristics between the subject device (e-SDF) and the predicate device, aiming to show substantial equivalence. The performance is assessed through non-clinical testing.
| Acceptance Criteria (Implied by Equivalence Comparison) | Reported Device Performance (e-SDF) | Equivalence to Predicate (Silver Dental Arrest - K102973) |
|---|---|---|
| Intended Use | Treatment of dentinal hypersensitivity. For use in adults over the age of 21. | Similar |
| Classification Name | Cavity Varnish | Equivalent |
| Common Name | Tooth desensitizer | Equivalent |
| Classification Product Code & Regulation Number | PHR, 21 CFR 872.3260 | Similar |
| Material Composition | Silver diamine fluoride | Similar |
| Mode of Action | Tubule occlusion (forms precipitates with calcium or phosphate in the dentinal tubules to block open dentinal tubules) | Similar |
| Application | Liquid | Similar |
| Sterility, Packaging | Non-Sterile, Bulk Pack | Similar |
| OTC/Rx | Rx | Similar |
| Biocompatibility | Biocompatible as per ISO 10993-1 | Similar |
| Hydraulic Conductance (Functional Efficacy) | Effective agent to reduce fluid flow through dentine; substantially equivalent to Silver Dental Arrest (Advantage arrest) in treating dentinal hypersensitivity. | Substantially Equivalent |
| Mechanism of Action (Microscopic Evidence) | SEM images showed e-SDF formed a precipitate to occlude the open dentinal tubules. | Similar (predicate also forms precipitate) |
2. Sample Size for the Test Set and Data Provenance:
The document mentions a "Hydraulic Conductance study" and "Scanning electron microscope (SEM) images" as part of non-clinical performance testing. However, it does not specify the sample size used for these tests (e.g., number of teeth, dentin samples).
The data provenance is also not explicitly stated. It's non-clinical lab testing, so it likely occurred in a controlled laboratory environment, but the country of origin of the lab or whether it was prospective/retrospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the provided document describes non-clinical performance testing (a "Hydraulic Conductance study" and SEM imaging) rather than a clinical study requiring expert assessment for ground truth. The evaluation criteria for the Hydraulic Conductance study and SEM images would be based on scientific measurements and observations, not expert consensus on diagnoses.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reason as point 3. There is no human interpretation or diagnostic ground truth being established in the non-clinical tests described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device e-SDF is a dental product (cavity varnish/tooth desensitizer), not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. As mentioned above, the device is a dental product, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used:
For the non-clinical tests described:
- Hydraulic Conductance Study: The ground truth would be the measured reduction in fluid flow through dentin, quantifiable by established scientific methods.
- Scanning Electron Microscope (SEM) Images: The ground truth is the visual evidence of precipitate formation and occlusion of dentinal tubules, observed microscopically.
8. The sample size for the training set:
This is not applicable. The e-SDF is a physical dental product, not a machine learning model, so there is no concept of a "training set" for its development or evaluation in the context of this submission.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
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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.
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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
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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 LLP411, Akruti Arcade, Jp Road, Opp A.H Wadia school, Andheriwest, Mumbai, India400053http://kids-e-dental.com/+91-7506-038-332drmukul@kids-e-dental.com |
| Primary Contact for this510(k)Submission | kids-e-dental LLP411, Akruti Arcade, Jp Road, Opp A.H Wadia school, Andheriwest, Mumbai, India400053http://kids-e-dental.com/+91-7506-038-332drmukul@kids-e-dental.com |
| Device Common Name | Tooth Desensitizer |
| Trade Name | e-SDF |
| Device Product CodesandClassification | 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% silverdiamine fluoride.Silver diamine fluoride solution is applied to thetooth, to reduce tooth sensitivity by physically occluding the opendentinal tubules. e-SDF is a liquid that is applied to the teethusing 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 Devicee-SDF | Predicate DeviceSilver Dental Arrest (102973) | Equivalency |
|---|---|---|---|
| Company Name | Kids-e-DentalLLP, India | Elevate Oral Care(named as ADP Silver DentalArrest, LLC in 510k), USA | NA |
| ClassificationName | Cavity Varnish | Cavity Varnish | Equivalent |
| Common Name | Tooth desensitiser | Tooth desensitiser | Equivalent |
| Indications for Use | Treatment ofdentinalhypersensitivity.For use in adults overtheage of 21. | Treatment ofdentinalhypersensitivity.For use in adults over the ageof21. | Similar |
| ClassificationProduct Code &RegulationNumber | PHR, 21 CFR 872.3260 | PHR, 21 CFR 872.3260 | Similar |
| Materialcomposition | Silver diamine fluoride | Silver diamine fluoride | Similar |
| Mode of action | Tubule occlusion | Tubule occlusion | Similar |
| Application: | Liquid | Liquid | Similar |
| Technical method/ characteristics: | Silver diamine fluorideforms precipitates withcalcium or phosphate inthe dentinal tubules toblock open dentinaltubules | Silver diamine fluoride formsprecipitates with calcium orphosphate in the dentinal tubulesto block open dentinal tubules | Similar |
| Sterility,Packaging | Non-Sterile, Bulk Pack | Non-Sterile, Bulk Pack | Similar |
| Description | Subject Devicee-SDF | Predicate DeviceSilver Dental Arrest (K102973) | Equivalency |
| OTC/Rx | Rx | Rx | Similar |
| Biocompatibility | Biocompatible asper 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.
§ 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.