FiteBac CC OrthoSeal

K210115 · Largent Health, LLC · DYH · Jul 29, 2021 · Dental

Device Facts

• Record ID: K210115
• Device Name: FiteBac CC OrthoSeal
• Applicant: Largent Health, LLC
• Product Code: DYH · Dental
• Decision Date: Jul 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended 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.

Device Story

FiteBac® CC OrthoSeal is a light-cured orthodontic primer containing 5% K18 Quaternary Ammonium Methacrylate (QAMS). It is applied to etched enamel surfaces by a dental professional in a clinical setting to prepare the tooth for bonding orthodontic appliances. The device functions as a methacrylate-based sealant; it is cured using a light source. The inclusion of K18 QAMS is intended to provide antimicrobial properties without negatively affecting the bond strength of orthodontic adhesives. The device is supplied in polyethylene bottles. Clinical benefit is derived from its role in the orthodontic bonding process, ensuring secure attachment of appliances to the tooth surface.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluation included bond strength testing and biocompatibility assessments (cytotoxicity, sensitization, and irritation) in accordance with ISO 10993 standards. Results confirmed the device is substantially equivalent to predicate devices.

Technological Characteristics

Methacrylate-based sealant containing 5% K18 Quaternary Ammonium Methacrylate (QAMS). Supplied as a liquid in polyethylene bottles. Light-cured (10-second cure time). Complies with ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 for biocompatibility.

Indications for Use

Indicated for use as a light cure primer to prepare etched enamel surfaces for the bonding of orthodontic appliances.

Regulatory Classification

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.

Predicate Devices

• Ultradent Opal® Seal™ (K090355)
• Transbond Light Cured Adhesive (Transbond XT Primer) (K880393)

Reference Devices

• Lang Orthodontic Acrylic 2 (K163482)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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: 06/30/2023 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.

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information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

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

Company Name:

Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064 Phone: [phone]

#### 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: [phone] 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 [e-mail]

# Secondary Contact:

Patricia D. Jones, VP of Regulatory Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 [e-mail]

- 3. 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

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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:

4.

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:

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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.

- 8. 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 Device<br>FiteBac® CC<br>OrthoSeal | Primary Predicate<br>Ultradent Opal®<br>Seal™<br>K090355 | Predicate Device<br>Transbond Light<br>Cured Orthodontic<br>Adhesive (Transbond<br>XT Primer)<br>K0880393 | *Reference Device<br>Lang Orthodontic<br>Acrylic 2<br>K163482 | Comparison<br>Results |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------|
| Indication for<br>Use Statement | FiteBac® CC OrthoSeal<br>with K18 QAMS is a<br>light cure primer<br>intended to prepare the<br>tooth surface prior to<br>bonding orthodontic<br>appliances to etched<br>enamel. | Opal® Seal is a<br>light cure primer<br>that is used when<br>bonding orthodontic<br>appliances to<br>etched enamel. | N/A | N/A | Comparable |
| Principle of<br>Operation | Methacrylate Sealant | Methacrylate<br>Sealant | Methacrylate Sealant | Methacrylate-based<br>material | Equivalent to<br>predicates |
| Available<br>Configurations | Liquid | Liquid in a single<br>barrel syringe | Liquid | Liquid and Powder | Equivalent to<br>predicate<br>devices |
| Size | 6 mL | 1.2- or 3-mL<br>Syringe | 6 mL | Multiple Sizes | Equivalent to<br>secondary<br>predicate<br>device |
| Package | Polyethylene Bottles | NA | Polyethylene Bottles | Polyethylene<br>Bottles | Equivalent to<br>secondary<br>predicate<br>device |

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

| Characteristics | Subject Device<br>FiteBac® CC<br>OrthoSeal | Primary Predicate<br>Ultradent Opal®<br>Seal™<br>K090355 | Predicate Device<br>Transbond Light<br>Cured Orthodontic<br>Adhesive (Transbond<br>XT Primer)<br>K0880393 | *Reference Device<br>Lang Orthodontic<br>Acrylic 2<br>K163482 | Comparison<br>Results |
|-----------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------|
| Biocompatibility | Yes - see table 12.2.1 | Yes | Yes | Yes | Equivalent to<br>predicate<br>devices |
| CC OrthoSeal Light Curing Specification Comparison with Ultradent Opal® Seal™ (K090355) | | | | | |
| Characteristics | | Subject Device<br>FiteBac® CC OrthoSeal<br>K210115 | | Primary Predicate<br>Ultradent Opal® Seal™<br>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.

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### 10. Performance Standards:

FiteBac® CC OrthoSeal complies with the following performance standards:

| Recognition<br># | Area | Title of Standard | Reference<br>Number and<br>Date | Standards<br>Development<br>Organization |
|------------------|------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------------------------|
| 2-258 | Biocompatibility | Biological Evaluation of<br>Medical Devices - Part 1:<br>Evaluation in Testing<br>Within a Risk Management<br>Process | 10993-1:2018 | ISO |
| 2-245 | Biocompatibility | Biological Evaluation of<br>Medical Devices - Part 5:<br>Tests for In Vitro<br>Cytotoxicity | 10993-5:2009 | ISO |
| 2-174 | Biocompatibility | Biological Evaluation of<br>Medical Devices - Part 10:<br>Tests for Skin Irritation and<br>Delayed 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.