(129 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the solution, with no mention of AI or ML.
Yes
The device is described as a "professional treatment for dentin hypersensitivity," which directly addresses a medical condition (dentin hypersensitivity) with the aim of alleviating symptoms.
No
The device is described as a "professional treatment for dentin hypersensitivity," indicating its purpose is therapeutic (to treat a condition), not diagnostic (to identify or determine a condition).
No
The device description explicitly states it is a solution presented in a dropper bottle, indicating it is a physical substance and 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 patient's dentin, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a solution applied topically.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any condition. Its sole purpose is to treat a symptom (dentinal hypersensitivity).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin / dentinal tubules
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)
Stability Test: To determine if the product remains stable during the proposed 2-year shelf life. Result: FAgamin® is physically and chemically stable in the proposed package for a period of 24 months (Pass).
Dentin Hydraulic Conductance: To demonstrate that FAgamin® is a dentin desensitizer similar to Advantage Arrest by measuring hydraulic conductance. Result: There were no significant differences between FAgamin® and Advantage Arrest p> 0.05 (Pass).
Fluoride release: To determine and compare the amount of fluoride release from FAgamin® and Advantage Arrest after application over teeth in vitro in water at 37°C during 7 days. Result: There are no significant differences between the two SDF in terms of fluorine ion release after application over teeth (Pass).
SEM-EDS: To compare the effect of FAgamin® and Advantage Arrest on phosphoric acid treated dentin. Result: 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).
ISTA 3A: To evaluate the ability of a package to protect its contents during transport. Result: No external damage to the transport packaging was observed (Pass).
ISO 10993-5 Cytotoxicity: To evaluate the cytotoxic potential of FAgamin®. Result: Non-Cytotoxic from a dilution of 1/320,000 (Pass).
Sensitization: To evaluate the sensitization potential of FAgamin®. Result: It could not be demonstrated that the substance produces sensitization reactions (Pass).
Irritation: To evaluate the irritation potential of FAgamin®. Result: Under the conditions of the study, not an irritant (Pass).
ISO 10993-11 Sistemic Toxicity: To evaluate the Sistemic Toxicity potential of FAgamin®. Result: The sample complies with the requirements of the assay (Pass).
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 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"
1
(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
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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."
4
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 |
| 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 AD |
| Silver 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
5
| Specifications | ||
|---|---|---|
| Test/Assey | Parameter | Specification |
| SDF titration | Silver Diamine Fluoride Conc. | 36- 40% W/V |
| Potenciom. Selective ion | ||
| elect. | 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 as | |
| ADP Silver Dental Arrest LLC in | |||
| 510k) | Different | ||
| Classification | |||
| Name | Cavity Varnish | Cavity Varnish | Same |
| Common | |||
| Name | Tooth Desensitizer | Tooth Desensitizer | Same |
| Regulation | |||
| Number | 872.3260 | 872.3260 | Same |
| Classification | Class 2 | Class 2 | Same |
| Product Code | PHR | PHR | Same |
| Indications for | |||
| Use | Treatment of dentinal | ||
| hypersensitivity. For use in | |||
| adult over the age of 21. | Treatment of dentinal | ||
| hypersensitivity. For use in | |||
| adult over the age of 21. | Same | ||
| Technical | |||
| Method / | |||
| Characteristics | FAgamin® reacts with calcium | ||
| and phosphates to form | |||
| precipitates that block the | |||
| dentinal tubules | Advantage Arrest reacts with | ||
| calcium and phosphates to | |||
| form precipitates that block | |||
| the dentinal tubules | Same | ||
| Mode of Action | Dentinal tubule obliteration. | Dentinal tubule obliteration. | Same |
| Material | |||
| Composition | Silver diamine fluoride, | ||
| Purified Water | Silver diamine fluoride Purified | ||
| Water 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 Bottle | |
| 8ml bottle Three 3ml bottle kit | Similar |
6
| Specifications | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| Fluoride | |||
| Release | The maximum rate of fluoride | ||
| release is 0.026 ppm/mm2 | The maximum rate of fluoride | ||
| release is 0.024 ppm/mm2 | There is no | ||
| significant | |||
| difference | |||
| between | |||
| both SDF | |||
| SEM/ EDS | |||
| Analysis | Deposites of silver, calcium, | ||
| fluoride and phosphate were | |||
| observed on dentin and | |||
| blocking tubules. | Deposites containing silver, | ||
| calcium and phosphate were | |||
| observed on dentin and | |||
| blocking tubules. | Same | ||
| Dentin | |||
| Permeability | Dentin permeability was | ||
| measured by means of | |||
| hydraulic conductance. | |||
| % Average FAgamin $\pm$ DS | |||
| 34.51 $\pm$ 12.61 | Dentin permeability was | ||
| measured by means of | |||
| hydraulic conductance. | |||
| % Average FAgamin $\pm$ DS | |||
| 30.72 $\pm$ 12.49 | No | ||
| significant | |||
| differences | |||
| between | |||
| FAgamin® | |||
| and | |||
| Advantage | |||
| Arrest 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 the | ||
| product remains stable | |||
| during the proposed 2- | |||
| year shelf life, | FAgamin® is physically and | ||
| chemically stable in the | |||
| proposed package for a | |||
| period of 24 months | Pass | ||
| Dentin Hydraulic | |||
| Conductance | To demonstrate that | ||
| FAgamin® is a dentin | |||
| desensitizer similar to | |||
| Advantage Arrest by | |||
| measuring hydraulic | |||
| conductance. | There were no significant | ||
| differences between | |||
| FAgamin® and Advantage | |||
| Arrest p> 0.05. | Pass | ||
| Fluoride release | To determine and | ||
| compare the amount of | |||
| fluoride release from | |||
| FAgamin® and Advantage | |||
| Arrest after application | |||
| over teeth in vitro in water | |||
| at 37°C during 7 days. | There are no significant | ||
| differences between the | |||
| two SDF in terms of | |||
| fluorine ion release after | |||
| application over teeth. | Pass | ||
| SEM- EDS | To compare the effect of | ||
| FAgamin® and Advantage | FAgamin® is similar to | ||
| Advantage Arrest and | |||
| both SDFs are | Pass |
7
| 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 10993-5 | |||
| Citotoxicity | 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 10993-11 | |||
| Sistemic 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.