FAgamin® is presented in a 5 ml black dropper bottle and contains a 38% w/v solution of diamine silver fluoride. Its design includes a secure screw cap and labeled container.

AI/ML Overview

The provided document is a 510(k) Summary for the medical device FAgamin®, a cavity varnish for the treatment of dentinal hypersensitivity. It does not describe a study involving an AI/ML algorithm or its performance. The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study proving device effectiveness against acceptance criteria in the context of AI.

Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML, human expert involvement, and AI performance metrics cannot be found in this document.

However, I can extract information about the non-clinical tests performed and their criteria, which act as "acceptance criteria" for demonstrating substantial equivalence based on non-clinical performance.

Here's the information that can be extracted from the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Parameters)

Test/Assay	Parameter	Acceptance Criteria	Reported Device Performance (Result)
Appearance	Appearance	Clear Liquid	Clear Liquid
Color	Color	colorless	colorless
Odor	Odor	ammonia	ammonia
pH	pH	8 a 10	8 to 10
Density	Density (15°C)	1.25 a 1.35 g/ml	1.25 a 1.35 g/ml
Volhard titration	Silver Ions Conc.	24.1- 26.8 % W/V	24.1- 26.8 % W/V
SDF titration	Silver Diamine Fluoride Conc.	36- 40% W/V	36- 40% W/V
Potenciom. Selective ion elect.	Fluoride ion conc.	4.2 - 4.7 W/V	4.2 - 4.7 W/V
Microbiological Test	not applicable	not applicable	not applicable
Stability Test	Exp. Data	FAgamin® is physically and chemically stable in the proposed package for a period of 24 months	Pass (product remains stable during the proposed 2-year shelf life)
Dentin Hydraulic Conductance	Hydraulic Conductance	There were no significant differences between FAgamin® and Advantage Arrest p > 0.05.	Pass (% Average FAgamin ± DS 34.51 ± 12.61 vs. Predicate 30.72 ± 12.49; no significant differences)
Fluoride Release	Fluoride release rate	There are no significant differences between the two SDF [Subject Device and Predicate] in terms of fluorine ion release after application over teeth.	Pass (Maximum rate of fluoride release is 0.026 ppm/mm² for FAgamin®, vs. 0.024 ppm/mm² for predicate; no significant difference)
SEM- EDS	Tubule Obliteration	FAgamin® is similar to Advantage Arrest and both SDFs are desensitizing agents by obliterating the dentinal tubules with deposits containing silver, phosphorus and calcium.	Pass (Deposits of silver, calcium, fluoride, and phosphate were observed on dentin and blocking tubules, similar to predicate)
ISTA 3A	Package Protection	No external damage to the transport packaging was observed.	Pass (No external damage to the transport packaging was observed)
ISO 10993-5 Citotoxicity	Cytotoxicity	Non-Cytotoxic from a dilution of 1/320,000.	Pass (Non-Cytotoxic from a dilution of 1/320,000)
Sensitization	Sensitization Potential	It could not be demonstrated that the substance produces sensitization reactions.	Pass (It could not be demonstrated that the substance produces sensitization reactions)
Irritation	Irritation Potential	Under the conditions of the study, not an irritant	Pass (Under the conditions of the study, not an irritant)
ISO 10993-11 Sistemic Toxicity	Systemic Toxicity	The sample complies with the requirements of the assay	Pass (The sample complies with the requirements of the assay)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of an AI/ML study.
For the non-clinical tests, specific sample sizes (e.g., number of dentin samples, number of packages) are not provided in this summary.
Data provenance (country of origin, retrospective/prospective) for these non-clinical tests is not detailed, though the applicant is from Argentina.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document does not describe an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The non-clinical tests are laboratory-based.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This document does not describe an AI/ML study.

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

Not applicable. This document describes a medical device (cavity varnish), not an AI/ML software. No MRMC study was performed.

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

Not applicable. This document describes a medical device, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" refers to the established scientific and engineering criteria and measurements (e.g., chemical composition analysis, physical properties, biological assays, comparison to predicate device).

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI/ML algorithm. No training set was used.

9. How the ground truth for the training set was established

Not applicable. This document describes a medical device, not an AI/ML algorithm. No training set was used.

Summary of the Study Performed (Non-Clinical for Substantial Equivalence):

The studies conducted for the FAgamin® device were non-clinical laboratory tests designed to demonstrate its substantial equivalence to a legally marketed predicate device (Silver Dental Arrest, K102973). The purpose was to show that FAgamin® is as safe and effective, and performs as well as or better than the predicate device.

The non-clinical tests covered:

Physical and Chemical Properties: Appearance, color, odor, pH, density, silver ion concentration, silver diamine fluoride concentration, and fluoride ion concentration. These were compared against internal specifications and the predicate device's known properties.
Stability: To ensure a 2-year shelf life.
Efficacy surrogates:
- Dentin Hydraulic Conductance: Measured to demonstrate the device's ability to desensitize by reducing dentin permeability, with a criterion of no significant difference from the predicate device.
- Fluoride Release: Compared to the predicate device to ensure similar fluoride ion release, expected to contribute to its mechanism of action. The criterion was no significant difference.
- SEM-EDS Analysis: Used to observe the formation of deposits and obliteration of dentinal tubules, confirming a similar mechanism of action to the predicate. The criterion was similarity in effect and deposits.
Biocompatibility: Tests according to ISO 10993 standards including cytotoxicity, sensitization, irritation, and systemic toxicity. Criteria were established based on standard biological safety assessments.
Packaging Integrity: ISTA 3A test to ensure the packaging protects the contents during transport.

Conclusion from Non-Clinical Testing:
The document concludes that "The conclusions drawn from the non-clinical testing demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K102973."

No clinical testing was performed in support of this submission. Therefore, all performance claims are based on these non-clinical comparative tests.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

May 16, 2024

Tedequim SRL % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445

Re: K240059

Trade/Device Name: FAgamin® Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: PHR Dated: April 16, 2024 Received: April 16, 2024

Dear Juan Tezak:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240059

Device Name

FAgamin®

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary K240059

Prepared May 14, 2024

I) Applicant

Submitter	TEDEQUIM SRL
Address	Bv. Los Polacos 6136.Córdova, X5147GGP. Argentina
Contact	Mrs. Leonor Pasteris
Telephone	+54 93515112131
E-mail	lpasteris@tedequim.com.ar

FAgamin®

872.3260 PHR

Cavity varnish

Diammine Silver Fluoride Dental

Hypersensitivity Varnish

II) Device

Trade Name Common Name

Classification Name Regulation Number Product Code

III) Predicate Device

510(k) Number	K102973
Applicant	Elevate Oral Care (named as ADSilver Dental Arrest LLC in 510k)
Trade Name	Silver Dental Arrest
Classification Name	Cavity varnish
Regulation Number	872.3260

IV) Indication For Use

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

V) Device Description

FAgamin® is a professional treatment for dentin hypersensitivity. It is indicated for adults over 21 years of age.

FAgamin® is presented in a 5 ml black dropper bottle and contains a 38% w/v solution of diamine silver fluoride. Its design includes a secure screw cap and labeled container.

Specifications
Test/Assay	Parameter	Specification
Appearance	Appearance	Clear Liquid
Color	Color	colorless
Odor	Odor	ammonia
pH	pH	8 a 10
Density	Density (15°C)	1.25 a 1.35 g/ml
Volhard titration	Silver Ions Conc.	24.1- 26.8 % W/V

Table of specifications

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Specifications
Test/Assey	Parameter	Specification
SDF titration	Silver Diamine Fluoride Conc.	36- 40% W/V
Potenciom. Selective ionelect.	Fluoride ion conc.	4.2 - 4.7 W/V
Microbiological Test	not applicable	not applicable
Stability test	Exp. Data	2 years

Composition:

Silver diamine fluoride (CAS34445-07-3): 38%

ammonium hydroxide (CAS 1336-21-6) and distilled water (CAS7732-18-5): 62%

VI) Comparison of Technological Characteristics

Specifications	Subject Device	Predicate Device	Discussion
Device name	Fagamin®	Advantage Arrest	N/A
510(k) Number	K240059	K102973	N/A
Company	Tedequim SRL	Elevate Oral Care (named asADP Silver Dental Arrest LLC in510k)	Different
ClassificationName	Cavity Varnish	Cavity Varnish	Same
CommonName	Tooth Desensitizer	Tooth Desensitizer	Same
RegulationNumber	872.3260	872.3260	Same
Classification	Class 2	Class 2	Same
Product Code	PHR	PHR	Same
Indications forUse	Treatment of dentinalhypersensitivity. For use inadult over the age of 21.	Treatment of dentinalhypersensitivity. For use inadult over the age of 21.	Same
TechnicalMethod /Characteristics	FAgamin® reacts with calciumand phosphates to formprecipitates that block thedentinal tubules	Advantage Arrest reacts withcalcium and phosphates toform precipitates that blockthe dentinal tubules	Same
Mode of Action	Dentinal tubule obliteration.	Dentinal tubule obliteration.	Same
MaterialComposition	Silver diamine fluoride,Purified Water	Silver diamine fluoride PurifiedWater FD&C Blue 1	Similar
Color	Colorless	Blue	Different
% SDF	38%	38%	Same
Application	Liquid	Liquid	Same
pH	8 to 10	9.3	Superior
Density (15°C)	1.25 a 1.35 g/ml	1.275 g/ml	Similar
Rx / OTC	Rx	Rx	Same
Packaging	5 ml Black dropper bottle	Squeezable Dropper Bottle8ml bottle Three 3ml bottle kit	Similar

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Specifications	Subject Device	Predicate Device	Discussion
FluorideRelease	The maximum rate of fluoriderelease is 0.026 ppm/mm2	The maximum rate of fluoriderelease is 0.024 ppm/mm2	There is nosignificantdifferencebetweenboth SDF
SEM/ EDSAnalysis	Deposites of silver, calcium,fluoride and phosphate wereobserved on dentin andblocking tubules.	Deposites containing silver,calcium and phosphate wereobserved on dentin andblocking tubules.	Same
DentinPermeability	Dentin permeability wasmeasured by means ofhydraulic conductance.% Average FAgamin $\pm$ DS34.51 $\pm$ 12.61	Dentin permeability wasmeasured by means ofhydraulic conductance.% Average FAgamin $\pm$ DS30.72 $\pm$ 12.49	NosignificantdifferencesbetweenFAgamin®andAdvantageArrest p>0.05.

FAgamin® and its predicate Silver Dental Arrest are very similar products in terms of their intended use, composition and efficacy in the treatment of dentin hypersensitivity.

VII) Summary of Non-Clinical Testing

Test	Purpose	Criteria	Result
Stability Test	To determine if theproduct remains stableduring the proposed 2-year shelf life,	FAgamin® is physically andchemically stable in theproposed package for aperiod of 24 months	Pass
Dentin HydraulicConductance	To demonstrate thatFAgamin® is a dentindesensitizer similar toAdvantage Arrest bymeasuring hydraulicconductance.	There were no significantdifferences betweenFAgamin® and AdvantageArrest p> 0.05.	Pass
Fluoride release	To determine andcompare the amount offluoride release fromFAgamin® and AdvantageArrest after applicationover teeth in vitro in waterat 37°C during 7 days.	There are no significantdifferences between thetwo SDF in terms offluorine ion release afterapplication over teeth.	Pass
SEM- EDS	To compare the effect ofFAgamin® and Advantage	FAgamin® is similar toAdvantage Arrest andboth SDFs are	Pass

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Test	Purpose	Criteria	Result
	Arrest on phosphoric acid treated dentin.	desensitizing agents by obliterating the dentinal tubules with deposits containing silver, phosphorus and calcium.
ISTA 3A	To evaluate the ability of a package to protect its contents during transport.	No external damage to the transport packaging was observed.	Pass
ISO 10993-5Citotoxicity	To evaluate the cytotoxic potential of FAgamin®	Non-Cytotoxic from a dilution of 1/320,000.	Pass
Sensitization	To evaluate the sensitization potential of FAgamin®	It could not be demonstrated that the substance produces sensitization reactions.	Pass
Irritation	To evaluate the irritation potential of FAgamin®	Under the conditions of the study, not an irritant	Pass
ISO 10993-11Sistemic Toxicity	To evaluate the Sistemic Toxicity potential of FAgamin®	The sample complies with the requirements of the assay	Pass

VIII) Summary of Clinical Testing

No clinical testing was performed in support of this submission.

IX) Conclusion

The conclusions drawn from the non-clinical testing demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K102973.

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.