American Orthodontics' BracePaste™ Adhesive is intended for use as an orthodontic bonding agent for Metal Brackets, Ceramic Brackets and Buccal Tubes to the tooth's surface.

Device Description

BracePaste™ Adhesive is a light-curing adhesive used as an orthodontic bonding agent for metal brackets, ceramic brackets and buccal tubes. The adhesive will be offered in syringe and carpule containers which will allow a precise volume to be dispensed during orthodontic treatment.

The flow consistency (medium viscosity) of the adhesive allows for easy manipulation, yet does not allow bracket "drift" during placement. The flowable consistency also allows for precise dispensing and application of the adhesive.

The adhesive contains Bis GMA and Bis EMA as resin fillers. A combination of silanized strontium aluminum boron silicate glass and silanized silica is used as fillers (Silane Treated Quartz; Silane Treated Silica). The inorganic loading is approximately 72% by weight.

When exposed to light by a photoinitiator system, the methacrylate functionalities of the resin and fillers undergo a polymerization reaction which hardens or "cures" the adhesive. The adhesive in turn will create a "bond" to which the orthodontic appliance becomes attached to etched enamel surface.

AI/ML Overview

The American Orthodontics' BracePaste™ Adhesive is an orthodontic bonding agent intended for use with metal brackets, ceramic brackets, and buccal tubes to the tooth's surface. The submission includes performance testing to demonstrate its substantial equivalence to the predicate device, Transbond™ XT (K880393).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses the performance of the predicate device, Transbond™ XT, as the acceptance criteria for the BracePaste™ Adhesive. The study aims to show comparable performance.

Test Method (Implicit Acceptance Criteria)	BracePaste™ Adhesive Reported Performance	Transbond™ XT (Predicate) Reported Performance
Bond Strength on Enamel (24 hrs. in water)	29.66 N/mm²	30.62 N/mm²
Young's Modulus	13,766 MPa	16,468 MPa
Flexural Strength	109 MPa	123 MPa
Compressive Strength	259 MPa	241 MPa

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes for each non-clinical performance test (e.g., number of specimens tested for bond strength, Young's Modulus, etc.).

The data provenance is from non-clinical bench testing performed by American Orthodontics and "side-by-side comparison performed by the original manufacturer." This suggests the data is prospective in nature, as it was generated specifically for this submission. The country of origin of the data is not specified, but it's generated by American Orthodontics, a U.S.-based company.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This question is not applicable as the described tests are non-clinical (bench testing) and do not involve human interpretation or subjective assessments that would require experts to establish ground truth. The "ground truth" for these tests is the quantitative measurement obtained through standardized test methods (e.g., ISO, DIN standards).

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as point 3. Bench tests do not involve adjudication.

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:

This question is not applicable. The device is an orthodontic adhesive, not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant. The testing conducted is non-clinical performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. The device is an orthodontic adhesive, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical performance tests, the "ground truth" is the quantitative measurements obtained through standardized physical and mechanical testing protocols (e.g., ISO 29022:2013, DIN 13990-1, DIN 13990-2, ISO 4049:2009, ISO 10993-5). The predicate device's performance serves as a comparative benchmark for these measurements.

8. The Sample Size for the Training Set:

This question is not applicable. The BracePaste™ Adhesive is a physical medical device (an adhesive), not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized graphic. The graphic depicts three human profiles facing right, layered on top of each other. The profiles are rendered in a simple, abstract style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2016

American Orthodontics Ms. Trang Adams Regulatory Affairs Specialist American Orthodontics 3524 Washington Avenue Sheboygan, Wisconsin 53081

Re: K160782

Trade/Device Name: Bracepaste Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: Class II Product Code: DYH Dated: September 9, 2016 Received: September 12, 2016

Dear Ms. Adams:

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. 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 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160782

Device Name BracePaste™ Adhesive

Indications for Use (Describe)

INDICATIONS FOR USE:

American Orthodontics' BracePaste™ Adhesive is intended for use as an orthodontic bonding agent for Metal Brackets, Ceramic Brackets and Buccal Tubes to the tooth's surface.

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)

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Image /page/3/Picture/0 description: The image shows the logo for American Orthodontics. The logo consists of the letters "AO" in a stylized, blue font, with the "O" being a complete circle. To the right of the letters, the words "AMERICAN ORTHODONTICS" are written in a simple, sans-serif font, also in blue. The word "AMERICAN" is above the word "ORTHODONTICS".

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081

www.americanortho.com

1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax

510(k) Summary

Preparation Date: September 9, 2016

Company Information:

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 Phone: 920-457-5051 Fax: 920-457-5773

Contact Information:

Trang Adams / Regulatory Affairs Specialist

Device Information:

Trade Name: BracePaste™ Adhesive Common Name: Orthodontic Adhesive Classification Name: Bracket Adhesive Resin and Tooth Conditioner Classification: Class II Product Code: DYH Regulation Number (21CFR): 872.3750

Predicate Device Information:

Product/Trade Name: Transbond™ XT Manufacturer: 3M Unitek 510(k) #: K880393 Classification: Class II Classification Name: Bracket Adhesive Resin and Tooth Conditioner Product Code: DYH Regulation Number (21CFR): 872.3750

Description of the Device:

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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 +1 920 457 5051 office +1 920 457 1485 fax

Indications for Use:

American Orthodontics' BracePaste™ Adhesive is intended for use as an orthodontic bonding agent for Metal Brackets, Ceramic Brackets and Buccal Tubes to the tooth's surface.

Substantial Equivalence Discussion:

The Indications for Use statement for American Orthodontics' BracePaste™ Adhesive is not identical to the predicate in that the subject device includes the additional indication of bonding of buccal tubes and wording is slightly different; however, the differences do not alter the intended use of the device relative to the predicate. Both devices have intended use, to be used as a bonding agent for orthodontic appliances.

Both devices have the same technological characteristics through delivery system. flow behavior. curing mechanism and incorporation of similar materials such as silane treated quartz and silane treated silica, Bis GMA and Bis EMMA, uv light stabilizers and initiators.

The table below outlines the comparisons of the predicate Transbond™ XT and American Orthodontics' BracePaste™ Adhesive to show substantial equivalency.

	Device Name / Manufacturer
Element	Transbond™ XT / 3M Unitek	BracePaste™ Adhesive / AmericanOrthodontics
510(k) Number	K880393	K160782
Classification Code/Regulation Number	DYH872.3750	DYH872.3750
Intended Use	3M Unitek Transbond™ XT is designedfor direct bonding of ceramic bracketsand metal brackets.	American Orthodontics' BracePaste™Adhesive is intended for use as anorthodontic bonding agent for MetalBrackets, Ceramic Brackets, and BuccalTubes to the tooth's surface.
Delivery System	Syringe / Carpule	Syringe / Carpule
Flow Behavior	Flowable	Flowable
Curing Mechanism	Orthodontic Curing Light	Orthodontic Curing Light
Filler Composition	Silane Treated QuartzSilane Treated Silica	Silane Treated QuartzSilane Treated Silica

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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, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font. The logo is in blue color. The logo is simple and modern.

American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081

www.americanortho.com

1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax

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. Biocompatibility/Cytotoxicity according to ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity
1. Viscosity and Consistency Test
1. Drift Test
Performance/Shear Bond Strength in accordance to ISO 29022:2013 4.
1. Compatibility Testing
1. Shear Bond Strength in accordance to DIN 13990-1 (2009) Dentistry – Test Methods for Shear Bond Strength of Adhesives for Orthodontic Attachments – Part 1: Bonding of the Interfacial Surfaces Adhesive-Attachment and Adhesive-Enamel and DIN 13990-2 (2009) Dentistry – Test Methods for Shear Bond Strength of Adhesive for Orthodontic Attachments – Part 2: Bonding of the Entire Bonding System Attachment-Adhesive-Enamel
1. Density Testing
Compressive Testing 8.
1. Flexural Strength and Modulus of Elasticity Testing according to ISO 4049:2009 Polymer-Based Restorative Materials
1. Surface Hardness Testing

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 BracePaste™ Adhesive. Results of bench testing indicate that BracePaste™ Adhesive performs as well as the predicate Transbond™ XT. Any slight differences do not affect the original function or intended purpose of the device.

Test Method	BracePaste™ Adhesive	Transbond XT
Bond Strength on Enamel (24 hrs.in water)	29.66 N/mm²	30.62 N/mm²
Young's Modulus	13,766 MPa	16,468 MPa
Flexural Strength	109 MPa	123 MPa
Compressive Strength	259 MPa	241 MPa

Test Method Summary:

Conclusion:

BracePaste™ Adhesive has the following similarities to the legally marketed predicate Transbond™ XT (K880393):

. Same intended use, and
Same technological characteristics through delivery system, flow behavior, curing mechanism and ● incorporation of similar materials.

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.