BracePaste Fluoride Sealant

K242537 · American Orthodontics Corp. · DYH · Aug 27, 2024 · Dental

Device Facts

• Record ID: K242537
• Device Name: BracePaste Fluoride Sealant
• Applicant: American Orthodontics Corp.
• Product Code: DYH · Dental
• Decision Date: Aug 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel. BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

Device Story

BracePaste Fluoride Sealant is a light-curing, methacrylate-based resin primer/sealant; used by orthodontists or dental professionals in clinical settings to prepare etched enamel surfaces for direct or indirect bonding of orthodontic appliances. The liquid sealant is applied to the tooth surface to increase adhesion; cured via light activation. The device is supplied in a 6mL dropper bottle; intended for long-term oral contact (>30 days). It functions as a chemical interface to improve bond strength between the tooth and orthodontic hardware. Benefits include enhanced adhesion and fluoride release during orthodontic treatment.

Clinical Evidence

No clinical performance testing conducted. Substantial equivalence supported by non-clinical bench testing including shear bond strength (ISO 29022:2013), stability, fluoride measurements, depth of cure, water sorption/solubility, and comprehensive biocompatibility testing (cytotoxicity, systemic toxicity, genotoxicity, irritation, and sensitization).

Technological Characteristics

Methacrylate-based resin; light-activated curing; liquid form; light yellow color; fluoride-containing; supplied in 6mL dropper bottle. Biocompatible per ISO 10993-1 and ISO 7405. Shipped unsterile.

Indications for Use

Indicated for orthodontic treatment of malocclusions and craniofacial abnormalities in patients requiring orthodontic bonding, as diagnosed by a trained dental professional or orthodontist.

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

• Opal Seal (K090355)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 27, 2024

American Orthodontics Corp. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K242537

Trade/Device Name: BracePaste Fluoride Sealant Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket adhesive resin and tooth conditioner Regulatory Class: Class II Product Code: DYH Dated: August 24, 2024 Received: August 26, 2024

Dear Dave Yungvirt:

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.

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

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 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 -S

Michael E. Adjodha, MChE, RAC, CQIA 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}------------------------------------------------

# Indications for Use

Submission Number (if known)

K242537

Device Name

BracePaste Fluoride Sealant

Indications for Use (Describe)

BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel.

BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

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

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 [e-mail]

"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."

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

Image /page/3/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized, geometric font, with the word "AMERICAN" above the word "ORTHODONTICS" to the right of the letters. The logo is in a blue color and the background is white.

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081

www.americanortho.com

1 800 558 7687 [phone] office [phone] fax

# K242537

# 510(k) Summary 21CFR807.92

Preparation Date: August 5th, 2024

#### Company Information:

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 Phone: [phone] Fax: [phone]

#### Submitter Information:

Luke Hetue | Supplier Quality Engineer

#### Device Information:

Trade Name: BracePaste Fluoride Sealant Common Name: Orthodontic Primer Classification Name: Bracket Adhesive Resin and Tooth Conditioner 510(k) Number: unknown Product Code: DYH Regulation Number (21CFR): 872.3750

#### Predicate Device Information:

Product/Trade Name: Opal Seal Classification Name: Bracket Adhesive Resin and Tooth Conditioner 510(k) Number: K090355 Product Code: DYH Regulation Number (21CFR): 872.3750

#### Description of the Device:

American Orthodontics' BracePaste Fluoride Sealant is a light-curing primer that is intended for use in orthodontic treatment as diagnosed by a trained dental professional or orthodontist. The primer prepares the enamel during orthodontic treatment to increase adhesion to the bonding surface by wetting the bonding surface of the object to be bonded.

#### Indications for Use:

BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel.

BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

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

Image /page/4/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, with the word "AMERICAN" above the word "ORTHODONTICS" to the right of the letters. The logo is in a blue color.

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081

www.americanortho.com

1 800 558 7687 [phone] office [phone] fax

# Substantial Equivalence Discussion:

BracePaste Fluoride Sealant has the following similarities to the legally marketed predicate Opal Seal (K090355):

- Same intended use, and .
- Same technological characteristics through delivery system, chemical characteristics, curing . method, and incorporation of similar materials.

The table below outlines the comparison of the predicate device (Opal Seal), and American Orthodontics' device (BracePaste Fluoride Sealant) to show Substantial Equivalence.

| | | Device Name / Manufacturer |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element | Device: Opal Seal<br>Manufacturer: Ultradent Products, Inc. | Device: BracePaste Fluoride Sealant<br>Manufacturer: American Orthodontics |
| 510(k) Number | K090355 | unknown |
| Classification<br>Code / Regulation<br>Number | DYH<br>872.3750 | DYH<br>872.3750 |
| Indications for<br>Use / Intended<br>Use | Opal Seal is a light cure primer that is used when<br>bonding orthodontic appliances to etched enamel. | BracePaste Fluoride Sealant is a light-cure primer /<br>sealant intended to be used in the bonding<br>procedure (direct or indirect) of orthodontic<br>bondable devices by preparing the bonding surface<br>during orthodontic treatment to the etched enamel.<br>BracePaste Fluoride Sealant is indicated for the<br>orthodontic treatment of malocclusions and<br>craniofacial abnormalities as diagnosed by a trained<br>dental professional or orthodontist. |
| Type and<br>Duration of<br>Tissue Contact | Long term use (used continuously for more than<br>thirty days)<br>Location - oral cavity, direct contact with tooth<br>enamel<br>Duration - greater than thirty days | Long term use (used continuously for more than<br>thirty days)<br>Location - oral cavity, direct contact with tooth<br>enamel<br>Duration - greater than thirty days |
| Delivery System | 1.7g syringe | 6mL Dropper Bottle |
| Material Type | Methacrylate based resin | Methacrylate based resin |
| Color | Light Yellow | Light Yellow |
| Physical Form | Liquid | Liquid |
| Storage<br>Conditions | Under recommended storage conditions of 2 – 8 °C<br>(36 - 46 °F), product has a shelf life of 18 months. | Under recommended storage conditions of 3 - 25 °C<br>(38 - 77 °F), product has a shelf life of 3 years. |
| Curing Method | Light Activated | Light Activated |
| Presence of<br>Fluoride | Yes | Yes |
| Sterile | Shipped Unsterile | Shipped Unsterile |
| Limits of Reuse | Tips are single use only | Do not re-use used/dispensed product |

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

Image /page/5/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized font, with the word "AMERICAN" above the word "ORTHODONTICS" to the right of the letters. The logo is in blue.

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081

www.americanortho.com

1 800 558 7687 [phone] office [phone] fax

| Biocompatibility | Biocompatible per ISO 7405, ISO 10993-1<br>Refer to FDA 510(k) submission K090355. | Biocompatible per ISO 7405, ISO 10993-1<br>Refer to Section 15 – Biocompatibility |
|------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
|------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|

# Performance Testing:

Clinical Performance Testing

No clinical performance testing has been conducted.

## Non-Clinical Performance Testing

The following non-clinical performance tests were conducted:

- 1. Shear Bond Strength Test (ISO 29022:2013) predicate device
- 2. Stability Study
- 3. Interaction with Accessories
- 4. Fluoride Measurements
- 5. Depth of Cure
- Evaluation of Reapplication 6.
- 7. Water Sorption and Water Solubility
- 8. Evaluation of Air Dry, Tack Cure

Non-Clinical Biocompatibility Testing

- 1. Cytotoxicity Direct Contact
- 2. Cytotoxicity Elution
- 3. Acute Systemic Toxicity Test
- 4. Genotoxicity Bacterial Reverse Mutation Test
- Genotoxicity Mouse Lymphoma Assay 5.
- 6. Irritation Intracutaneous Reactivity
- 7. Sensitization Delayed Hypersensitization Test
- 8. Subacute/Subchronic Systemic Toxicity Test

The combination of in-house testing and side-by-side comparison performed by the original manufacturer has demonstrated the efficacy or suitability to the intended purpose of the BracePaste Fluoride Sealant. Results of all conducted testing was found acceptable and does not raise any new issues of safety or effectiveness.

#### Conclusion:

The combination of in-house testing and side-by-side comparison performed by the original manufacturer has demonstrated the efficacy or suitability to the intended purpose of the BracePaste Fluoride Sealant. Results of bench testing indicate that BracePaste Fluoride Sealant performs as well as the predicate Opal Seal.

Both devices have the same intended use – to prepare the enamel and increase adhesion to the bonding surface during orthodontic treatment.

Any slight differences do not affect the original function or intended purpose of the device.

Information contained in this 510(k) does not raise new questions or safety and effectiveness and, demonstrates BracePaste Fluoride Sealant is at least as safe and effective as the predicate.