FiteBac Cavity Cleanser

K190271 · Largent Health, LLC · LBH · Jan 23, 2020 · Dental

Device Facts

• Record ID: K190271
• Device Name: FiteBac Cavity Cleanser
• Applicant: Largent Health, LLC
• Product Code: LBH · Dental
• Decision Date: Jan 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2

Intended Use

The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.

Device Story

FiteBac Cavity Cleanser is a 2% K21 quaternary ammonium silane-functionalized (QAS) aqueous ethanolic solution; used by dentists to cleanse and moisten/rewet prepared dental surfaces following tooth preparation or etching; applied prior to sealing dentinal tubules; removes debris in carious lesion preparations; penetrates exposed dentin tubules to facilitate restorative adhesive binding; supplied in liquid form in low-density polyethylene bottles; intended for prescription use in clinical dental settings; benefits include improved preparation of dentin surfaces for restorative procedures.

Clinical Evidence

No clinical data. Bench testing only, including bond strength testing and biocompatibility assessments (cytotoxicity and sensitization).

Technological Characteristics

2% K21 Quaternary Ammonium Silane-functionalized (QAS) aqueous ethanolic solution; liquid form; packaged in low-density polyethylene bottles; non-electronic; chemical-based cleansing and re-wetting agent.

Indications for Use

Indicated for cleansing and moistening/rewetting of cavity preparations in patients undergoing dental restorative procedures.

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

• Bisco Cavity Cleanser (K915668)

Reference Devices

• Ascent Dental Cleanser (K070070)
• Lang Orthodontic Acrylic 2 (K163482)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 23, 2020

Largent Health, LLC % Elizabeth O'Keeffe Director of Regulatory Affairs Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K190271

Trade/Device Name: FiteBac Cavity Cleanser Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: Class II Product Code: LBH Dated: January 8, 2020 Received: January 14, 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

{1}------------------------------------------------

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 medical devices and radiation-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,

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

{2}------------------------------------------------

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) K190271

#### Device Name

FiteBac® Cavity Cleanser

Indications for Use (Describe)

The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/rewetting of cavity preparations.

Type of Use (Select one or both, as applicable) 区 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)

Page 1 of 1

PSC Publishing Services [phone] EF

{3}------------------------------------------------

## K190271

# 6 510(k) Summary

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the FiteBac® Cavity Cleanser is provided below.

| Date | February 8, 2019 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Largent Health, LLC<br>3698 Largent Way NW, Suite 101<br>Marietta, GA 30064<br>Phone: [phone] |
| 510(k) Contact | Secure BioMed Evaluations<br>Elizabeth O'Keeffe, Ph.D.<br>7828 Hickory Flat Highway Suite 120<br>Woodstock, GA 30188<br>770-837-2681 (direct)<br>[e-mail] |
| Trade Name | FiteBac® Cavity Cleanser |
| Common Name | Varnish, Cavity |
| Code -Classification | LBH: Class II |
| Predicate Device | K915668 Bisco Cavity Cleanser |
| Reference Device | K070070 Ascent Dental Cleanser |
| Reference Device | K163482 Lang Orthodontic Acrylic 2 |

## Device Description

The FiteBac® Cavity Cleanser is a 2% K21 Quaternary Ammonium Silane-functionalized (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. Research has shown that FiteBac® Cavity Cleanser can not only remove debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes.

## Intended Use

The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.

{4}------------------------------------------------

## Technological Characteristics

The subject device has substantially equivalent technological characteristics to the predicate device and/or the reference devices in terms of principles of operation, intended use, material performance, and biocompatibility.

## Non-clinical Testing - Bench Study Comparison

The subject device has mechanical and physical properties substantially equivalent to commercially available devices with the same intended uses. The following characteristics were evaluated

## Performance Testing

- . Bond Strength Testing
## Non-Clinical Testing – Biocompatibility

- Cytotoxicity
- . Sensitization

## Substantial Equivalence Summary (Conclusion)

FiteBac® Cavity Cleanser has the same intended use, principles of operation and substantially equivalent technological characteristics as the predicate device Bisco Cavity Cleanser (K915668) and the reference device Ascent Dental Cleanser (K070070). Although FiteBac® Cavity Cleanser differs from the predicate and reference devices in the source of solution component (K21 QAS versus Chlorhexidine Digluconate), FiteBac® Cavity Cleanser and the reference device Lang Orthodontic Acrylic 2 both use the same functionalized quaternary ammonium molecule found in the FiteBac® QAS molecule as a source of product component. The subject device and the predicate and reference devices active ingredients have been shown to effectively cleanse and prepare carious lesions for restoration without diminishing restoration bond strength. FiteBac® Cavity Cleanser is as safe and effective as the predicate and reference comparator devices currently cleared for marketing in the United States. Additional biocompatibility and non-clinical testing demonstrate FiteBac® Cavity Cleanser is as safe and effective as these devices and does not raise additional questions of safety and effectiveness.

A comparison of the subject device to the predicate devices is shown in the following table.

| Trait | FiteBac® Cavity<br>Cleanser™ | Bisco Cavity Cleanser<br>(Predicate) | Ascent Dental Cleanser<br>(Reference) | Lang Orthodontic Acrylic<br>(Reference) | Comparison/<br>Equivalent to |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) number | TBD | K915668 | K070070 | K163482 | N/A |
| FDA Regulation | 872.3260 | 872.3690 | 872.3260 | 872.3760 | Equivalent to<br>reference |
| Product Code | LBH | EBF | LBH | EBI | Equivalent to<br>reference |
| Trait | FiteBac® Cavity<br>Cleanser™ | Bisco Cavity<br>Cleanser<br>(Predicate) | Ascent Dental<br>Cleanser<br>(Reference) | Lang Orthodontic<br>Acrylic<br>(Reference) | Comparison/<br>Equivalent to |
| Product<br>Classification | Class II | Class II | Class II | Class II | Equivalent to<br>predicate and<br>reference<br>devices |
| Use | Prescription Use<br>Part 21 CFR 801<br>Subpart D | Prescription Use<br>Part 21 CFR 801<br>Subpart D | Prescription Use<br>Part 21 CFR 801<br>Subpart D | Prescription Use<br>Part 21 CFR 801<br>Subpart D | Equivalent to<br>predicate and<br>reference<br>devices |
| Intended Use | The FiteBac®<br>Cavity Cleanser is<br>a 2% K21 QAS<br>aqueous ethanolic<br>solution intended<br>for cleansing and<br>moistening/re-<br>wetting of cavity<br>preparations | BISCO's Cavity<br>Cleanser is a 2%<br>chlorhexidine<br>digluconate<br>aqueous solution<br>intended for<br>cleansing and<br>moistening/re-<br>wetting cavity<br>preparations. | The Ascent Dental<br>Cleanser is<br>indicated for the<br>cleansing and<br>disinfecting only of<br>tooth cavity<br>preparations in<br>conjunction with<br>dental restorative<br>procedures | Orthodontic<br>Acrylic 2 is<br>intended for the<br>fabrication of<br>methacrylate-<br>based orthodontic<br>appliances (such<br>as retainers, bite<br>guards, and bite<br>plates, etc.) | Equivalent to<br>predicate |
| Principle of<br>Operation | Cleansing and re-<br>wetting of carious<br>preparations | Cleansing and re-<br>wetting of carious<br>preparations | Cleansing of<br>carious<br>preparations | Fabricating<br>orthodontic<br>appliances | Equivalent to<br>predicate |
| Composition | 2% K21 QAS | 2% Chlorhexidine<br>Digluconate | Chlorhexidine<br>Gluconate | 5% K18 QAMS | Equivalent to<br>reference<br>device |
| Available<br>Configurations | Liquid | Liquid | Liquid | Liquid, Powder | Equivalent to<br>predicate and<br>reference<br>devices |
| Size | 8 mL | 7 mL or 150 mL | unknown | Multiple sizes | N/A |
| Package | Low Density<br>Polyethylene<br>Bottles | 7 mL: Low Density<br>Polyethylene<br>135 mL: High<br>Density<br>Polyethylene | unknown | High Density<br>Polyethylene<br>Bottles | Equivalent to<br>predicate |
| Biocompatibility | Yes | Yes | unknown | Yes | Equivalent to<br>predicate and<br>reference<br>devices |

{5}------------------------------------------------