e-SDF

K240619 · Kids-E-Dental Llp · PHR · Mar 6, 2024 · Dental

Device Facts

• Record ID: K240619
• Device Name: e-SDF
• Applicant: Kids-E-Dental Llp
• Product Code: PHR · Dental
• Decision Date: Mar 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Treatment of dentinal hypersensitivity. For use in adults over the age of 21.

Device Story

e-SDF is a 38% silver diamine fluoride liquid solution used to treat dentinal hypersensitivity. Applied by a clinician to the tooth surface using an applicator brush, the solution acts by physically occluding open dentinal tubules. It reacts with calcium or phosphate within the tubules to form precipitates, effectively blocking fluid flow. This process reduces sensitivity for the patient. The device is intended for professional use in a clinical setting.

Clinical Evidence

No clinical data. Evidence consists of bench testing: a hydraulic conductance study demonstrated e-SDF effectively reduces fluid flow through dentine, comparable to the predicate. Scanning electron microscope (SEM) imaging confirmed precipitate formation and tubule occlusion. Biocompatibility testing was performed in accordance with ISO 10993-1:2018 and ISO 7405:2018.

Technological Characteristics

Liquid formulation containing 38% silver diamine fluoride. Acts via chemical precipitation with calcium/phosphate to occlude dentinal tubules. Non-sterile, bulk packaging. Biocompatibility compliant with ISO 10993-1 and ISO 7405. Prescription-only device.

Indications for Use

Indicated for the treatment of dentinal hypersensitivity in adults over the age of 21.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Silver Dental Arrest (Advantage arrest) (K102973)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

K240619

| Date Summary was Prepared | February 20th 2024 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | kids-e-dental LLP<br>411, Akruti Arcade, Jp Road, Opp A.H Wadia school, Andheri<br>west, Mumbai, India400053<br>http://kids-e-dental.com/<br>[phone]<br>[e-mail] |
| Primary Contact for this<br>510(k)Submission | kids-e-dental LLP<br>411, Akruti Arcade, Jp Road, Opp A.H Wadia school, Andheri<br>west, Mumbai, India400053<br>http://kids-e-dental.com/<br>[phone]<br>[e-mail] |
| Device Common Name | Tooth Desensitizer |
| Trade Name | e-SDF |
| Device Product Codes<br>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<br>diamine fluoride.Silver diamine fluoride solution is applied to the<br>tooth, to reduce tooth sensitivity by physically occluding the open<br>dentinal tubules. e-SDF is a liquid that is applied to the teeth<br>using an applicator brush or similar application. |
| Indications for Use | Treatment of dentinal hypersensitivity.<br>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<br>e-SDF | Predicate Device<br>Silver Dental Arrest (102973) | Equivalency |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Company Name | Kids-e-Dental<br>LLP, India | Elevate Oral Care<br>(named as ADP Silver Dental<br>Arrest, LLC in 510k), USA | NA |
| Classification<br>Name | Cavity Varnish | Cavity Varnish | Equivalent |
| Common Name | Tooth desensitiser | Tooth desensitiser | Equivalent |
| Indications for Use | Treatment of<br>dentinal<br>hypersensitivity.<br>For use in adults over<br>theage of 21. | Treatment of<br>dentinal<br>hypersensitivity.<br>For use in adults over the age<br>of21. | Similar |
| Classification<br>Product Code &<br>Regulation<br>Number | PHR, 21 CFR 872.3260 | PHR, 21 CFR 872.3260 | Similar |
| Material<br>composition | Silver diamine fluoride | Silver diamine fluoride | Similar |
| Mode of action | Tubule occlusion | Tubule occlusion | Similar |
| Application: | Liquid | Liquid | Similar |
| Technical method<br>/ characteristics: | Silver diamine fluoride<br>forms precipitates with<br>calcium or phosphate in<br>the dentinal tubules to<br>block open dentinal<br>tubules | Silver diamine fluoride forms<br>precipitates with calcium or<br>phosphate in the dentinal tubules<br>to block open dentinal tubules | Similar |
| Sterility,<br>Packaging | Non-Sterile, Bulk Pack | Non-Sterile, Bulk Pack | Similar |
| Description | Subject Device<br>e-SDF | Predicate Device<br>Silver Dental Arrest (K102973) | Equivalency |
| OTC/Rx | Rx | Rx | Similar |
| Biocompatibility | Biocompatible as<br>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.