(349 days)
No
The summary describes a chemical solution for dental cavity preparation and does not mention any AI or ML components or functions.
No
The device is described as a cleanser and moistening/re-wetting solution for cavity preparations, used prior to sealing dentinal tubules, and its primary function is to remove debris and improve binding of restorative adhesives. It does not actively treat a disease or condition for therapeutic benefit, but rather prepares the site for another treatment.
No
The device is described as a "Cavity Cleanser" intended for "cleansing and moistening/re-wetting of cavity preparations" and "prepared dental surfaces." Its stated function is to remove debris and prepare the tooth for bonding, which is a therapeutic or preparatory function, not a diagnostic one. There is no mention of it being used to identify, detect, or monitor a disease or condition.
No
The device is a liquid solution intended for cleansing and moistening, which is a physical substance, not software.
Based on the provided information, the FiteBac® Cavity Cleanser is not an In Vitro Diagnostic (IVD).
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 (the tooth cavity) for a physical/chemical action (cleansing and moistening).
- Device Description: The description reinforces the intended use, focusing on its application to prepared dental surfaces and its potential interaction with dentin tubules and restorative adhesives.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. IVDs are typically used to analyze samples like blood, urine, tissue, etc.
- Anatomical Site: The anatomical site is "cavity preparations," which is a part of the human body, not a specimen taken from the body.
- Performance Studies: The performance studies mentioned are "Bond Strength Testing," "Cytotoxicity," and "Sensitization." These are tests related to the device's physical properties, biocompatibility, and interaction with the tooth structure, not diagnostic performance metrics like sensitivity or specificity.
- Predicate Device: The predicate device, K915668 Bisco Cavity Cleanser, also appears to be a dental material for cavity preparation, not an IVD.
In summary, the FiteBac® Cavity Cleanser is a dental material intended for direct application to a tooth cavity for cleansing and moistening purposes. This function falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/rewetting of cavity preparations.
Product codes (comma separated list FDA assigned to the subject device)
LBH
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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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: Bond Strength Testing.
Non-Clinical Testing – Biocompatibility: Cytotoxicity, Sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 (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
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 (301)443-6740 EF
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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 |
| 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® 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
Cleanser™ | Bisco Cavity Cleanser
(Predicate) | Ascent Dental Cleanser
(Reference) | Lang Orthodontic Acrylic
(Reference) | Comparison/
Equivalent to |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) number | TBD | K915668 | K070070 | K163482 | N/A |
| FDA Regulation | 872.3260 | 872.3690 | 872.3260 | 872.3760 | Equivalent to
reference |
| Product Code | LBH | EBF | LBH | EBI | Equivalent to
reference |
| Trait | FiteBac® Cavity
Cleanser™ | Bisco Cavity
Cleanser
(Predicate) | Ascent Dental
Cleanser
(Reference) | Lang Orthodontic
Acrylic
(Reference) | Comparison/
Equivalent to |
| Product
Classification | Class II | Class II | Class II | Class II | Equivalent to
predicate and
reference
devices |
| Use | Prescription Use
Part 21 CFR 801
Subpart D | Prescription Use
Part 21 CFR 801
Subpart D | Prescription Use
Part 21 CFR 801
Subpart D | Prescription Use
Part 21 CFR 801
Subpart D | Equivalent to
predicate and
reference
devices |
| Intended Use | The FiteBac®
Cavity Cleanser is
a 2% K21 QAS
aqueous ethanolic
solution intended
for cleansing and
moistening/re-
wetting of cavity
preparations | BISCO's Cavity
Cleanser is a 2%
chlorhexidine
digluconate
aqueous solution
intended for
cleansing and
moistening/re-
wetting cavity
preparations. | The Ascent Dental
Cleanser is
indicated for the
cleansing and
disinfecting only of
tooth cavity
preparations in
conjunction with
dental restorative
procedures | Orthodontic
Acrylic 2 is
intended for the
fabrication of
methacrylate-
based orthodontic
appliances (such
as retainers, bite
guards, and bite
plates, etc.) | Equivalent to
predicate |
| Principle of
Operation | Cleansing and re-
wetting of carious
preparations | Cleansing and re-
wetting of carious
preparations | Cleansing of
carious
preparations | Fabricating
orthodontic
appliances | Equivalent to
predicate |
| Composition | 2% K21 QAS | 2% Chlorhexidine
Digluconate | Chlorhexidine
Gluconate | 5% K18 QAMS | Equivalent to
reference
device |
| Available
Configurations | Liquid | Liquid | Liquid | Liquid, Powder | Equivalent to
predicate and
reference
devices |
| Size | 8 mL | 7 mL or 150 mL | unknown | Multiple sizes | N/A |
| Package | Low Density
Polyethylene
Bottles | 7 mL: Low Density
Polyethylene
135 mL: High
Density
Polyethylene | unknown | High Density
Polyethylene
Bottles | Equivalent to
predicate |
| Biocompatibility | Yes | Yes | unknown | Yes | Equivalent to
predicate and
reference
devices |
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