(206 days)
Not Found
No
The device description focuses on the chemical composition and physical properties of an orthodontic adhesive, with no mention of AI or ML.
No
This device is an adhesive used to bond orthodontic appliances to teeth, indicating it is an accessory used in a therapeutic process rather than a therapeutic device itself.
No
The device is an adhesive used to bond orthodontic brackets and tubes to teeth, which is a therapeutic function, not diagnostic.
No
The device description clearly indicates that BracePaste™ Adhesive is a physical substance (an adhesive) composed of resins and fillers, dispensed in syringes and carpules, and undergoes a polymerization reaction when exposed to light. This is a hardware/material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to bond orthodontic brackets and tubes to the tooth's surface. This is a direct application to the patient's body for a therapeutic purpose (orthodontic treatment).
- Device Description: The description details a light-curing adhesive used for bonding orthodontic appliances. It describes the chemical composition and how it hardens to create a bond.
- 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 in a laboratory setting to test samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device is a material used directly on the patient for a structural and therapeutic purpose.
N/A
Intended Use / 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.
Product codes
DYH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth's surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Clinical Performance Testing No clinical performance testing has been conducted.
Non-Clinical Performance Testing
The following non-clinical performance tests were conducted:
-
- Biocompatibility/Cytotoxicity according to ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity
-
- Viscosity and Consistency Test
-
- Drift Test
- Performance/Shear Bond Strength in accordance to ISO 29022:2013 4.
-
- Compatibility Testing
-
- 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
-
- Density Testing
- Compressive Testing 8.
-
- Flexural Strength and Modulus of Elasticity Testing according to ISO 4049:2009 Polymer-Based Restorative Materials
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bond Strength on Enamel (24 hrs. in water): 29.66 N/mm²
Young's Modulus: 13,766 MPa
Flexural Strength: 109 MPa
Compressive Strength: 259 MPa
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.
Not Found
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
§ 872.3750 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.
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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
1
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
2
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
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:
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.
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
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 / American |
| Orthodontics | ||
| 510(k) Number | K880393 | K160782 |
| Classification Code/ | ||
| Regulation Number | DYH | |
| 872.3750 | DYH | |
| 872.3750 | ||
| Intended Use | 3M Unitek Transbond™ XT is designed | |
| for direct bonding of ceramic brackets | ||
| and metal brackets. | 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. | ||
| Delivery System | Syringe / Carpule | Syringe / Carpule |
| Flow Behavior | Flowable | Flowable |
| Curing Mechanism | Orthodontic Curing Light | Orthodontic Curing Light |
| Filler Composition | Silane Treated Quartz | |
| Silane Treated Silica | Silane Treated Quartz | |
| Silane Treated Silica |
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, 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
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:
-
- Biocompatibility/Cytotoxicity according to ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity
-
- Viscosity and Consistency Test
-
- Drift Test
- Performance/Shear Bond Strength in accordance to ISO 29022:2013 4.
-
- Compatibility Testing
-
- 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
-
- Density Testing
- Compressive Testing 8.
-
- Flexural Strength and Modulus of Elasticity Testing according to ISO 4049:2009 Polymer-Based Restorative Materials
-
- 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.