(90 days)
Orthodontic Primers are intended to be used in the bonding procedure (direct or indirect) of brackets and tubes by preparing the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The Primer wets the bonding surface of the object to be bonded (i.e. enamel, composite materials, etc.) to promote adhesion.
American Orthodontics' BracePaste MTP Light Cure Primer is a light-curing primer that is intended to be used in direct or indirect bonding procedures of brackets and tubes. The primer prepares the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The primer "wets" the bonding surface of the object to be bonded [i.e. enamel, composite materials, etc.) to promote adhesion. The primer will be available in liquid form in a dropper bottle.
The primer contains Bisphenol a Diglycidyl Ether Dimethacrylate and 2-Hydroxyethyl Methacrylate resin compounds. These resin compounds are mixed with ethyl alcohol and water to form an aqueous solution. This solution has the hydrophilic characteristics necessary for the primer to adhere under wet conditions. Using a curing light, the irradiation causes the methylacrylate resins to undergo polymerization. This polymerization forms a bond between the etched enamel surface and the bracket adhesive.
The document describes the BracePaste MTP Light Cure Primer (K181910), an orthodontic primer, and its substantial equivalence to a predicate device, the Transbond MIP Primer (K962785). The primary acceptance criteria for such a device are related to its bond strength and other physical/chemical properties to ensure it performs as intended.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" values for bond strength. Instead, it presents a comparison of the subject device's performance against the predicate device, implying that performance similar to the predicate is the basis for acceptance.
| Test Method | Predicate Device Performance (Transbond MIP Primer) | Subject Device Performance (BracePaste MTP Light Cure Primer) | Implicit Acceptance Criteria (based on predicate) |
|---|---|---|---|
| Average Bond Strength | 38.70 N/mm² | 38.94 N/mm² | Similar to or better than 38.70 N/mm² |
| Refractive Index (20.0°C) | 1.4441 | 1.4284 | Within a comparable range of 1.4441 |
The conclusion states that the BracePaste MTP Light Cure Primer "performs as well as the predicate Transbond MIP Primer," indicating that matching or exceeding the predicate's performance is the criterion for determining efficacy and suitability.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size in terms of the number of individual tests or specimens used for the non-clinical performance tests.
Data Provenance: The studies are described as "in-house testing" and "side-by-side comparison performed by the original manufacturer." This indicates the data is retrospective and likely originated from internal laboratory testing. The country of origin is not specified but is implicitly the location of the manufacturer (American Orthodontics, Sheboygan, Wisconsin, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an orthodontic primer, and the studies performed are non-clinical (in vitro and bench testing). The "ground truth" for these types of tests (like bond strength or refractive index) is established by direct physical measurement, not by expert interpretation or consensus.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on direct physical measurements from bench tests, there is no need for expert 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
Not applicable. This is a physical device (orthodontic primer), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI-related effectiveness are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the non-clinical performance tests (e.g., average bond strength, refractive index) is derived from direct physical and chemical measurements obtained through standardized laboratory testing (e.g., DIN 13990-2, ISO 29022:2013).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not a machine learning algorithm.
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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.
American Orthodontics Andre Leak Regulatory Affairs Coordinator 3524 Washington Avenue Sheboygan, Wisconsin 53081
Re: K181910
Trade/Device Name: BracePaste MTP Light Cure Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, DYH Dated: July 17, 2018 Received: July 17, 2018
Dear Andre Leak:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
October 15, 2018
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S3
For 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) K181910
Device Name BracePaste MTP Light Cure Primer
Indications for Use (Describe)
Orthodontic Primers are intended to be used in the bonding procedure (direct or indirect) of brackets and tubes by preparing the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The Primer wets the bonding surface of the object to be bonded (i.e. enamel, composite materials, etc.) to promote adhesion.
| 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 a triangle shape forming the "A". To the right of the letters, the words "AMERICAN ORTHODONTICS" are written in a smaller, sans-serif font, also in blue.
American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
Page 5-1
510(k) Summarv
21CFR807.92
Preparation Date: July 13, 2018
Company Information:
American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 Phone: 920-457-5051 Fax: 920-457-5773
Submitter Information:
Trang Adams / Regulatory Affairs Specialist
Device Information:
Trade Name: BracePaste MTP Light Cure Primer Common Name: Orthodontic Primer Classification Name: Agent, Tooth Bonding, Resin 510(k) Number: unknown Product Code: KLE Regulation Number (21CFR): 872.3200
Predicate Device Information:
Product/Trade Name: Transbond MIP Primer Classification Name: Agent, Tooth Bonding, Resin 510(k) Number: K962785 Product Code: KLE Regulation Number (21CFR): 872.3200
Description of the Device:
American Orthodontics' BracePaste MTP Light Cure Primer is a light-curing primer that is intended to be used in direct or indirect bonding procedures of brackets and tubes. The primer prepares the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The primer "wets" the bonding surface of the object to be bonded [i.e. enamel, composite materials, etc.) to promote adhesion. The primer will be available in liquid form in a dropper bottle.
The use of light-curing primers/adhesives has been around since 1970's. In the early 1980's, visible light-cured restorative materials were introduced. Hydrophilic primers were introduced in 1998. These primers were hydrophilic and bonded well to wet or dry enamel.
The primer contains Bisphenol a Diglycidyl Ether Dimethacrylate and 2-Hydroxyethyl Methacrylate resin compounds. These resin compounds are mixed with ethyl alcohol and water to form an aqueous solution. This solution has the hydrophilic characteristics necessary for the primer to adhere under wet conditions. Using a curing light, the irradiation causes the methylacrylate resins to undergo polymerization. This polymerization forms a bond between the etched enamel surface and the bracket adhesive
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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, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font. The letters and words are all in a dark blue color. The logo is simple and modern, and it is likely used to represent the company's brand.
American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081
1 800 558 7687 +1 920 457 5051 office +1 920 457 1485 fax
Page 5-2
Indications for Use:
Orthodontic Primers are intended to be used in the bonding procedure (direct or indirect) of brackets and tubes by preparing the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The Primer wets the bonding surface of the object to be bonded (i.e. enamel, composite materials, etc.) to promote adhesion.
Substantial Equivalence Discussion:
The Indications for Use statement for American Orthodontics' BracePaste MTP Light Cure Primer is not identical to the predicate in that the subject device's intended use is more descriptive. However, the differences do not alter the intended use of the device relative to the predicate. Both devices have the same intended use – to prepare the enamel for orthodontic treatment for bonding of brackets and tubes to increase adhesion.
Both devices have the same technological characteristics through delivery system, chemical characteristics, curing method, and incorporation of similar materials such as ethyl alcohol, Bisphenol a Diglycidyl Ether Dimethacrylate, 2-Hydroxyethyl Methacrylate, 2-Hydroxy-1,3-Dimethacryloxypropane, Diurethane Dimethacrylate, and Water.
| Device Name / Manufacturer | |||
|---|---|---|---|
| Element | Device: Transbond MIP PrimerManufacturer: 3M Dental Products Laboratory | Device: BracePaste MTP Light Cure PrimerManufacturer: American Orthodontics | |
| 510(k) Number | K962785 | unknown | |
| ClassificationCode/ RegulationNumber | KLE872.3200 | KLE872.3200 | |
| Intended Use | This product is intended for use in orthodontictreatment. | Orthodontic Primers are intended to be used in thebonding procedure (direct or indirect) of bracketsand tubes by preparing the enamel duringorthodontic treatment to increase adhesion to wetor dry, normal and atypical enamel surfaces. ThePrimer wets the bonding surface of the object to bebonded (i.e. enamel, composite materials, etc.) topromote adhesion. | |
| Delivery System | 6mL Dropper Bottle | 6mL Dropper Bottle | |
| MaterialComposition | · Ethyl Alcohol· Bisphenol a Diglycidyl Ether Dimethacrylate· 2-Hydroxyethyl Methacrylate· 2-Hydroxy-1,3-Dimethacryloxypropane· Diurethane Dimethacrylate· Water | · Ethyl Alcohol· Bisphenol a Diglycidyl Ether Dimethacrylate· 2-Hydroxyethyl Methacrylate· 2-Hydroxy-1,3-Dimethacryloxypropane· Diurethane Dimethacrylate· Water | |
| ChemicalCharacteristics | Hydrophilic | Hydrophilic | |
| Curing Method | Light Activated | Light Activated | |
| Consistency | Liquid | Liquid | |
| Bonding Type | Direct/Indirect | Direct/Indirect |
The table below outlines the comparison of the predicate device (Transbond MIP Primer) and subject device (BracePaste MTP Light Cure Primer) to show substantial equivalence.
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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 large, bold, sans-serif font, followed by the words "AMERICAN ORTHODONTICS" in a smaller, sans-serif font. The letters and words are all in the same 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
Page 5-3
Performance Testing:
Clinical Performance Testing No clinical performance testing has been conducted.
Non-Clinical Performance Testing
The following non-clinical performance tests were conducted:
- In vitro Cytotoxicity Assay: Direct Cell Contact Test with MTP Light Curable Moisture Tolerant ● Primer (Study No. 176263)
- Interaction with Accessories: MTP Light Curable Moisture Tolerant Primer Compatibility ●
- Stability Test: MTP Light Curable Moisture Tolerant Primer Compatibility
- Test Report # 1701006; DIN 13990-2 Primer Testing ●
- Test Report # 1706013: DIN 13990-2: Bond Strength of MTP Primer with BracePaste
- Test Report # 1708011: Moisture Tolerant Primer Adhesive Strength Testing
- Performance Testing in accordance with ISO 29022:2013 Dentistry-Adhesion-Notched-edge shear bond strength test
- . Test Protocol: Transbond MIP, 3M Unitek
- Test Protocol: MTP Light Curable Moisture Tolerant Primer .
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 MTP Light Cure Primer. Results of bench testing indicate that BracePaste MTP Light Cure Primer performs as well as the predicate Transbond MIP Primer.
Test Method Summary:
| Test Method | BracePaste MTP Light Cure Primer | Transbond MIP Primer |
|---|---|---|
| Average Bond Strength | 38.94/mm² | 38.70 N/mm² |
| Refractive Index (20.0°C) | 1.4284 | 1.4441 |
Conclusion:
In summary, BracePaste MTP Light Cure Primer has the following similarities to the legally marketed predicate Transbond MIP Primer (K962785):
- Same intended use, and ●
- Same technological characteristics through delivery system, chemical characteristics, curing ● method, consistency, bonding type (direct/indirect) and incorporation of similar materials.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.