(108 days)
No
The device description and performance studies focus on the antimicrobial properties of a chemical solution, with no mention of AI or ML technologies.
No
The device is described as an antimicrobial cleanser and re-wetting agent for cavity preparations, intending to remove debris and microorganisms to facilitate bonding of restorative adhesives, not to treat a disease or condition.
No
The device is an antimicrobial solution for cleansing and moistening dental cavity preparations. Its purpose is to prepare the tooth surface for restoration, not to diagnose a condition or disease.
No
The device is described as an "antimicrobial aqueous ethanolic solution," which is a liquid chemical 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 for "cleansing and moistening/re-wetting of cavity preparations." This is a direct application to a biological site (tooth cavity) for a therapeutic or preparatory purpose, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces the intended use, focusing on its antimicrobial action within the prepared dental surface and its role in preparing the dentin for bonding.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device acts directly on the site of treatment.
Therefore, based on the provided text, the FiteBac® Antimicrobial Cavity Cleanser is a therapeutic or preparatory device used in dentistry, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
Product codes
LBH
Device Description
The FiteBac® Antimicrobial Cavity Cleanser is an antimicrobial 2% K21 Quaternary Ammonium Silanefunctionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. FiteBac® Antimicrobial Cavity Cleanser acts on the microorganisms in the table below, and not only removes debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. In vitro studies, referenced below, demonstrated a reduction in the following microorganisms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
In the referenced literature, the subject device underwent antimicrobial effectiveness testing against Streptococcus mutans, Actinomyces naeslundii, Lactobacillus, and Candida albicans. Briefly, dentin blocks impregnated with each microorganism were treated with the subject device to determine the effectiveness of the subject device at reducing the microorganism from the dentin, in the reduction of each microorganism.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K190271 FiteBac® Cavity Cleanser
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.
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June 25, 2020
Largent Health, LLC % Elizabeth O'keeffe Director of Regulatory Affairs Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K200614
Trade/Device Name: FiteBac Antimicrobial Cavity Cleanser Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: March 28, 2020 Received: May 28, 2020
Dear Elizabeth O'keeffe:
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.
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
1
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 (OS) 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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K200614
Device Name
FiteBac® Antimicrobial Cavity Cleanser
Indications for Use (Describe)
The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
Type of Use (Select one or both, as applicable) 図 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."
FORM FDA 3881 (7/17)
PSC Publishing Services(301)443-6740 EF
3
K200614
6 510(k) Summary
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the FiteBac® Antimicrobial Cavity Cleanser is provided below.
| Date | March 6, 2020 |
|---|---|
| Submitted by | Largent Health, LLC |
| 3698 Largent Way NW, Suite 101 | |
| Marietta, GA 30064 | |
| Phone: 770-218-6221 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Elizabeth O'Keeffe, Ph.D. | |
| 7828 Hickory Flat Highway Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 (direct) | |
| Regulatory@SecureBME.com | |
| Trade Name | FiteBac® Antimicrobial Cavity Cleanser |
| Common Name | Varnish, Cavity |
| Code -Classification | LBH: Class II |
| Predicate Device | K190271 FiteBac® Cavity Cleanser |
Device Description
The FiteBac® Antimicrobial Cavity Cleanser is an antimicrobial 2% K21 Quaternary Ammonium Silanefunctionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. FiteBac® Antimicrobial Cavity Cleanser acts on the microorganisms in the table below, and not only removes debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. In vitro studies, referenced below, demonstrated a reduction in the following microorganisms.
| Microorganisms Susceptible to FiteBac® Antimicrobial Cavity Cleanser |
|---|
| Streptococcus mutans1 |
| Actinomyces naeslundii1 |
| Lactobacillus acidophilus2 |
| Candida albicans3 |
1 Gou YP, Li JY, Meghil MM, et al. Quatemary ammonium silane-based antibacterial and anti-proteolytic cavity cleanser. Dent Mater. 2018;34(12):1814-1827.
2 Daod U. Burrow MF, Yu CKY. Effect of a novel quaternary ammonium silane cavity disinfectant on cariogenic biofilm formation. Clin Oral Investig. 2020;24(2):649-661.
3 Data on File
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Indications for Use
The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.
Technological Characteristics
As the subject device is identical in formulation and manufacture, the subject device has substantially equivalent technological characteristics to the predicate device in terms of principles of operation, intended use, material performance, and biocompatibility.
Non-clinical Testing – Bench Study Comparison
As the subject device has the same formulation and manufacturing as the predicate device, the subject device has mechanical and physical properties identical to the predicate device. No additional biocompatibility testing was conducted for this submission.
In the referenced literature, the subject device underwent antimicrobial effectiveness testing against Streptococcus mutans, Actinomyces naeslundii, Lactobacillus, and Candida albicans. Briefly, dentin blocks impregnated with each microorganism were treated with the subject device to determine the effectiveness of the subject device at reducing the microorganism from the dentin, in the reduction of each microorganism.
Substantial Equivalence Summary (Conclusion)
FiteBac® Antimicrobial Cavity Cleanser subject device has equivalent intended use, principles of operation and the exact same technological characteristics as the predicate device FiteBac® Cavity Cleanser (K190271). Although the subject device includes and expanded antimicrobial claim, the subject device and the predicate device are the same formulation with the same manufacturing process. FiteBac® Antimicrobial Cavity Cleanser subject device is as safe and effective as the predicate device currently cleared for marketing in the United States and does not raise additional questions of safety and effectiveness.
| Trait | FiteBac® Antimicrobial Cavity Cleanser™
(Subject Device) | FiteBac® Cavity Cleanser™
(Predicate Device) | Comparison/
Equivalent to |
|---------------------------|-------------------------------------------------------------|-------------------------------------------------|------------------------------|
| 510(k) number | TBD | K190271 | N/A |
| FDA Regulation | 872.3260 | 872.3260 | Equivalent |
| Product Code | LBH | LBH | Equivalent |
| Product
Classification | Class II | Class II | Equivalent |
| Use | Prescription Use
Part 21 CFR 801 Subpart D | Prescription Use
Part 21 CFR 801 Subpart D | Equivalent |
A comparison of the subject device to the predicate device is shown in the following table.
5
| Trait | FiteBac® Antimicrobial Cavity Cleanser™
(Subject Device) | FiteBac® Cavity Cleanser™
(Predicate Device) | Comparison/
Equivalent to |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indications for
Use | The FiteBac® Antimicrobial Cavity
Cleanser with 2% K21 QAS is an
antimicrobial aqueous ethanolic solution
intended for cleansing and
moistening/re-wetting of cavity
preparations | The FiteBac® Cavity Cleanser is a 2% K21
QAS aqueous ethanolic solution
intended for cleansing and
moistening/re-wetting of cavity
preparations | Equivalent plus
Antimicrobial
Claim |
| Principle of
Operation | Cleansing and re-wetting of carious
preparations | Cleansing and re-wetting of carious
preparations | Equivalent |
| Composition | 2% K21 QAS | 2% K21 QAS | Equivalent |
| Available
Configurations | Liquid | Liquid | Equivalent |
| Size | 8 mL | 8 mL | Equivalent |
| Package | Low Density Polyethylene Bottles | Low Density Polyethylene Bottles | Equivalent |
| Biocompatibility | Yes | Yes | Equivalent |