FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.

Device Description

The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.

AI/ML Overview

The provided text describes the 510(k) summary for the FiteBac® CC OrthoSeal device. Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format for the device's performance characteristics. Instead, it categorizes performance testing, and the reported performance is described as being "acceptable" and not raising "any new issues of safety or effectiveness" in comparison to predicate devices. The primary performance characteristic mentioned is "Bond Strength Testing."

Acceptance Criteria (Implied)	Reported Device Performance
Bond Strength (Equivalent to predicate devices)	Results of all conducted testing including Bond Strength Testing was found acceptable and did not raise any new issues of safety or effectiveness. (Implied equivalence to predicate devices)
Biocompatibility (Meeting ISO standards)	Sensitization: Acceptable Cytotoxicity: Acceptable Irritation: Acceptable (Complied with ISO 10993-1, ISO 10993-5, ISO 10993-10)
Cure Time	10 seconds
Wavelength	< 600 mW/cm²

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 explicitly state the sample size used for the test set for "Bond Strength Testing" or the data provenance. It only mentions that "non-clinical testing" was performed.

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)

This information is not provided in the document. The testing described is non-clinical bench testing, not an effectiveness study requiring expert adjudication of patient data.

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

This information is not applicable as the testing described is non-clinical bench testing, not an effectiveness study involving human interpretation.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a light cure primer for orthodontic bonding, not an AI-assisted diagnostic tool.

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

This question is not applicable as the device is a chemical primer, not an algorithm. The non-clinical bench testing represents a "standalone" evaluation of the device's physical and chemical properties.

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

For Bond Strength Testing, the ground truth would be based on established engineering and materials science principles and validated testing methods for measuring adhesive bond strength. For Biocompatibility, the ground truth is established by the specified ISO standards (ISO 10993 series), which define acceptable biological responses.

8. The sample size for the training set

This is not applicable. The device is a chemical primer, not a machine learning model that requires a training set. The "testing summary" refers to non-clinical bench testing, not data used to train an algorithm.

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

This is not applicable since there is no training set for this device.

Summary

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

Image /page/0/Picture/0 description: The image shows 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.

July 29, 2021

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

Re: K210115

Trade/Device Name: FiteBac CC OrthoSeal Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket adhesive resin and tooth conditioner Regulatory Class: Class II Product Code: DYH Dated: May 28, 2021 Received: June 1, 2021

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 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,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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: 06/30/2023 See PRA Statement on last page.

510(k) Number (if known) K210115

Device Name

FiteBac® CC OrthoSeal

Indications for Use (Describe)

FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.

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 (6/20)

PSC Publishing Services(301)443-6740 EF

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

510(k) SUMMARY: FiteBac® CC OrthoSeal (K210115)

Company Name:

Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064 Phone: 770-218-6221

Date Prepared: July 28, 2021

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information:
  Applicant Name: Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064 Phone: 770-218-6221 Establishment Registration Number: 3015709927

2. Contact Person:

Elizabeth O'Keeffe, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy, Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com

Secondary Contact:

Patricia D. Jones, VP of Regulatory Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 Requlatory@SecureBME.com

1. Device Name and Classification: Trade Name: Classification Name:
  Common Name: Classification Panel: Regulation Number: Device Class: Product Codes:

FiteBac® CC OrthoSeal Bracket adhesive resin and tooth conditioner Adhesive. Bracket and Tooth Conditioner Dental 21 CFR §872.3750 DYH

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

Orthodontic

Primary Predicate Device: Ultradent Opal® Seal™ Trade Name: 510(k) Clearance: K090355 April 29, 2009 Clearance Date: Classification Name: Bracket adhesive resin and tooth conditioner Common Name: Adhesive, Bracket and Tooth Conditioner Dental Classification Panel: 21 CFR §872.3750 Regulation Number: Device Class: Product Codes: DYH Predicate Device: Trade Name: Transbond Light Cured Adhesive (Transbond XT Primer) 510(k) Clearance: K880393 March 31, 1988 Clearance Date: Bracket adhesive resin and tooth Classification Name: conditioner Common Name: Adhesive, Bracket and Tooth Conditioner Dental Classification Panel: Regulation Number: 21 CFR §872.3750 Device Class: Product Codes: DYH Reference Device: Orthodontic Acrylic 2 Trade Name: K163482 510(k) Clearance: May 31, 2017 Clearance Date: Classification Name: Denture relining, repairing, or rebasing resin. Classification Panel: Dental Regulation Number: 21 CFR §872.3760 Device Class: . EBI Product Codes:

5. Device Description:

The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.

Technological Characteristics:

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

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

6. Indications for Use:

FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.

7. Substantial Equivalence:

FiteBac® CC OrthoSeal has the same intended use, principles of operation and substantially equivalent technological characteristics as Ultradent's Opal® Seal™ (K090355). Although FiteBac® CC OrthoSeal differs from the predicate devices in the presence of K18 QAMS. FiteBac® CC OrthoSeal and the reference device Lang Orthodontic Acrylic 2 both contain this same K18 QAMS compound. Both the subject device and the predicate devices have been shown to prime teeth surfaces without negatively effecting the bond strength of orthodontic adhesives. FiteBac® CC OrthoSeal 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® CC OrthoSeal is as safe and effective as these devices and does not raise additional questions of safety and effectiveness.

1. Comparison of Technological Characteristics with the Predicate devices: A comparison of the subject device to the predicate devices and reference device is shown in the following table.

Characteristics	Subject DeviceFiteBac® CCOrthoSeal	Primary PredicateUltradent Opal®Seal™K090355	Predicate DeviceTransbond LightCured OrthodonticAdhesive (TransbondXT Primer)K0880393	*Reference DeviceLang OrthodonticAcrylic 2K163482	ComparisonResults
Indication forUse Statement	FiteBac® CC OrthoSealwith K18 QAMS is alight cure primerintended to prepare thetooth surface prior tobonding orthodonticappliances to etchedenamel.	Opal® Seal is alight cure primerthat is used whenbonding orthodonticappliances toetched enamel.	N/A	N/A	Comparable
Principle ofOperation	Methacrylate Sealant	MethacrylateSealant	Methacrylate Sealant	Methacrylate-basedmaterial	Equivalent topredicates
AvailableConfigurations	Liquid	Liquid in a singlebarrel syringe	Liquid	Liquid and Powder	Equivalent topredicatedevices
Size	6 mL	1.2- or 3-mLSyringe	6 mL	Multiple Sizes	Equivalent tosecondarypredicatedevice
Package	Polyethylene Bottles	NA	Polyethylene Bottles	PolyethyleneBottles	Equivalent tosecondarypredicatedevice

{6}------------------------------------------------

Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064

Characteristics	Subject DeviceFiteBac® CCOrthoSeal	Primary PredicateUltradent Opal®Seal™K090355	Predicate DeviceTransbond LightCured OrthodonticAdhesive (TransbondXT Primer)K0880393	*Reference DeviceLang OrthodonticAcrylic 2K163482	ComparisonResults
Biocompatibility	Yes - see table 12.2.1	Yes	Yes	Yes	Equivalent topredicatedevices
CC OrthoSeal Light Curing Specification Comparison with Ultradent Opal® Seal™ (K090355)
Characteristics		Subject DeviceFiteBac® CC OrthoSealK210115		Primary PredicateUltradent Opal® Seal™K090355
Time to Cure		10 seconds	20 seconds	20 seconds	10 seconds
Wavelength		< 600 mW/cm²	≥ 600 mW/cm²	< 600 mW/cm²	≥ 600 mW/cm²

*Reference Device Comparison Rationale: The reference device Lang Orthodontic Acrylic 2 (K163482) was chosen as a technological reference due to both the subject device and the reference device containing K18 QAMS. See relevant data provided in MAF2174.

9. Non-clinical Testing - Bench Study Comparison

The subject device has mechanical 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:

Sensitization ●
Cytotoxicity .
Irritation

Testing Summary:

Results of all conducted testing was found acceptable and do not raise any new issues of safety or effectiveness.

{7}------------------------------------------------

10. Performance Standards:

FiteBac® CC OrthoSeal complies with the following performance standards:

Recognition#	Area	Title of Standard	ReferenceNumber andDate	StandardsDevelopmentOrganization
2-258	Biocompatibility	Biological Evaluation ofMedical Devices - Part 1:Evaluation in TestingWithin a Risk ManagementProcess	10993-1:2018	ISO
2-245	Biocompatibility	Biological Evaluation ofMedical Devices - Part 5:Tests for In VitroCytotoxicity	10993-5:2009	ISO
2-174	Biocompatibility	Biological Evaluation ofMedical Devices - Part 10:Tests for Skin Irritation andDelayed Hypersensitivity	0993-10:2010	ISO

11. Conclusion as to Substantial Equivalence:

The FiteBac® CC OrthoSeal is comparable to listed Predicate Devices and any differences do not raise new questions of safety and effectiveness. When compared to marketed devices, performance data demonstrates that the FiteBac® CC OrthoSeal is at least as safe and effective as the Predicate Devices listed in this submission.

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.