(3 days)
A light cure orthodontic band cement intended to bond orthodontic bands to teeth.
American Orthodontics' BracePaste Band and Build LC is a light-cure band cement that is intended to bond orthodontic bands to teeth.
When an orthodontic band is required for orthodontic treatment, band cement is applied to the inside of the orthodontic band and then the band is seated onto the tooth. Once the band is seated properly, excess adhesive is cleaned up from the proximity of the band and tooth and the adhesive is cured via curing light. The polymerization of the adhesive forms a bond between the orthodontic band and / or the tooth enamel. Upon completion of orthodontic treatment, the orthodontic band is removed and any adhesive remaining on tooth enamel is cleaned up and removed from the tooth.
The provided document describes the 510(k) submission for "BracePaste Band and Build LC," an orthodontic band cement. The document states that no clinical performance testing has been conducted. The submission relies on non-clinical performance testing and a comparison to a predicate device to establish substantial equivalence.
Therefore, the following information regarding acceptance criteria, study details, and ground truth cannot be extracted as they are not present in the provided text.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable (no clinical testing).
- Data Provenance: Not applicable (no clinical testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (no clinical testing).
4. Adjudication method for the test set:
- Not applicable (no clinical testing).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is an orthodontic band cement, not an AI device for diagnostic reading.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI algorithm.
7. The type of ground truth used:
- Not applicable (no clinical testing). For non-clinical testing, relevant benchmarks were likely derived from material science standards.
8. The sample size for the training set:
- Not applicable (no machine learning model to train).
9. How the ground truth for the training set was established:
- Not applicable (no machine learning model to train).
Non-Clinical Performance Testing Details (as provided):
The document states that the following non-clinical performance tests were conducted:
- Shear Bond Strength Test (ISO 29022:2013)
- Accelerated Aging Stability Test
- Interaction with Accessories
The conclusion states that 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 Band and Build LC." It also states, "Results of bench testing indicate that BracePaste Band and Build LC performs as well as the predicate Light-Cured Orthodontic Band Cement." However, specific numerical acceptance criteria or reported performance values for these tests are not provided in the document.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 14, 2020
American Orthodontics % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155
Re: K202276
Trade/Device Name: BracePaste Band and Build LC Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket adhesive resin and tooth conditioner Regulatory Class: Class II Product Code: DYH Dated: August 10, 2020 Received: August 11, 2020
Dear Rafael Aguila:
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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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Indications for Use
510(k) Number (if known) K202276
Device Name BracePasteTM Band and Build LC
Indications for Use (Describe)
A light cure orthodontic band cement intended to bond orthodontic bands to teeth.
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 on the left side of the image. To the right of the letters, the words "AMERICAN ORTHODONTICS" are written in a simple, 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
K202276
510(k) Summary 21CFR807.92
Preparation Date: May 19, 2020
Company Information:
American Orthodontics 3524 Washington Avenue Sheboygan, WI 53081 Phone: 920-457-5051 Fax: 920-457-5773
Submitter Information:
Andre Leak / Regulatory Affairs Coordinator
Device Information:
Trade Name: BracePaste™ Band and Build LC Common Name: Orthodontic Band Cement Classification Name: Adhesive, Bracket And Tooth Conditioner, Resin 510(k) Number: unknown Product Code: DYH Regulation Number (21CFR): 872.3750
Predicate Device Information:
Product/Trade Name: Light-cured orthodontic band cement (Band Secure) Classification Name: Adhesive, Bracket And Tooth Conditioner, Resin 510(k) Number: K001446 Product Code: DYH Regulation Number (21CFR): 872.3750
Description of the Device:
American Orthodontics' BracePaste Band and Build LC is a light-cure band cement that is intended to bond orthodontic bands to teeth.
When an orthodontic band is required for orthodontic treatment, band cement is applied to the inside of the orthodontic band and then the band is seated onto the tooth. Once the band is seated properly, excess adhesive is cleaned up from the proximity of the band and tooth and the adhesive is cured via curing light. The polymerization of the adhesive forms a bond between the orthodontic band and / or the tooth enamel. Upon completion of orthodontic treatment, the orthodontic band is removed and any adhesive remaining on tooth enamel is cleaned up and removed from the tooth.
Indications for Use:
A light cure orthodontic band cement intended to bond orthodontic bands to teeth.
Substantial Equivalence Discussion:
BracePaste Band and Build LC has the following similarities to the legally marketed predicate Light-Cured Orthodontic Band Cement (K001446):
- Same intended use, and .
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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 large, bold, sans-serif font, with the word "AMERICAN" above the word "ORTHODONTICS" to the right of the letters. The logo is blue in color and the background is white.
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
Same technological characteristics through delivery system, chemical characteristics, curing method, consistency, and incorporation of similar materials.
The table below outlines the comparison of the predicate device (Light-Cured Orthodontic Band Cement), and American Orthodontics' device (BracePaste Band and Build LC) to show substantial Equivalence.
| Device Name / Manufacturer | ||
|---|---|---|
| Element | Device: Light-Cured Orthodontic Band CementManufacturer: Scientific Pharmaceuticals, Inc. | Device: BracePaste Band and Build LCManufacturer: American Orthodontics |
| 510(k) Number | K001446 | unknown |
| ClassificationCode/ RegulationNumber | DYH872.3750 | DYH872.3750 |
| Intended Use | Light-cure orthodontic band cement is intended foruse in cementation of orthodontic bands on teethrequiring application of forces exceeding thecapacity of bonded brackets. | A light cure orthodontic band cement intended tobond orthodontic bands to teeth. |
| Delivery System | Clinician applies a manual load to the plunger todispense adhesive from the tip of the syringe or thecarpule. | Clinician applies a manual load to the plunger todispense adhesive from the tip of the syringe or thecarpule. |
| Cement Type | Resin-Based | Resin-Based |
| Physical Form | Paste | Paste |
| Curing Method | Light Activated | Light Activated |
Performance Testing:
Clinical Performance Testing No clinical performance testing has been conducted.
Non-Clinical Performance Testing
The following non-clinical performance tests were conducted:
-
- Shear Bond Strength Test (ISO 29022:2013) predicate device
-
- Accelerated Aging Stability Test
-
- Interaction with Accessories
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 Band and Build LC.
Conclusion:
The combination of in-house testing and side-by-side comparison performed by the original manufacturer has demonstrated the efficacy and suitability to the intended purpose of the BracePaste Band and Build LC orthodontic band adhesive. Results of bench testing indicate that BracePaste Band and Build LC performs as well as the predicate Light-Cured Orthodontic Band Cement. Both devices have the same intended use - to bond orthodontic bands to teeth.
Any slight differences do not affect the original function or intended purpose of the device.
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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 on the left, with the word "AMERICAN" in a smaller, sans-serif font to the right of the "AO". Below "AMERICAN" is the word "ORTHODONTICS" in an even smaller, sans-serif font. The letters and words are all in a dark blue color.
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
Information contained in this 510(k) does not raise new questions or safety and effectiveness and, demonstrates BracePaste Band and Build LC is at least as safe and effective as the predicate.
§ 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.