(1 days)
No
The device description and performance studies focus on the material properties and mechanical performance of an orthodontic adhesive, with no mention of AI or ML.
No
The device is an orthodontic adhesive used for bonding brackets and creating attachments for aligners, which falls under the category of a dental material rather than a therapeutic device. A therapeutic device would typically be one that treats or prevents a disease or condition, or restores a function.
No
The device is an adhesive used for bonding orthodontic brackets to teeth and creating attachments. Its intended use does not involve diagnosing conditions or diseases.
No
The device description clearly states it is a physical adhesive material composed of resins and fillers, stored in a syringe, and used for bonding. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are "Creating attachments for orthodontic tray aligners" and "Bonding orthodontic brackets to teeth." These are procedures performed directly on a patient's teeth for orthodontic treatment.
- Device Description: The description details a dental adhesive used for bonding.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests outside of the body on biological samples to gain information about a person's health. This device is used inside the mouth for a physical bonding process.
N/A
Intended Use / Indications for Use
3M Transbond Orthodontic Adhesive is indicated for the following uses:
- · Creating attachments for orthodontic tray aligners.
- · Bonding orthodontic brackets to teeth.
Product codes
DYH
Device Description
3M Transbond Orthodontic Adhesive is a thixotropic, visible-light activated, radiopaque orthodontic adhesive. The product is stored in a multi-use syringe which is used with single-use dispensing tips.
3M Transbond Orthodontic Adhesive contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20 nm silica filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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
The following performance parameters were tested to demonstrate that the subject device performs as intended when used for creating attachments for orthodontic tray aligners or bonding brackets to teeth: Shear Bond Strength (adhesion), Depth of Cure (ISO 4049), Three-Body Wear Resistance, and Rheology.
FlowTain (predicate device) and/or 3M Transbond Supreme LV (reference device) were used as controls in these studies.
The performance bench studies and biocompatibility assesment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains 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.
December 22, 2023
3M Unitek Orthodontic Products % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K234043
Trade/Device Name: 3M™ Transbond™ Orthodontic Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket adhesive resin and tooth conditioner Regulatory Class: Class II Product Code: DYH Dated: December 20, 2023 Received: December 21, 2023
Dear Prithul Bom:
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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
3M TM Transbond TM Orthodontic Adhesive
Indications for Use (Describe)
3M Transbond Orthodontic Adhesive is indicated for the following uses:
- · Creating attachments for orthodontic tray aliqners.
- · Bonding orthodontic brackets 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| K234043 | ||||
|---|---|---|---|---|
| 510(k) Summary | Prepared on: 2023-12-08 | |||
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | 3M Unitek Orthodontic Products | |||
| Applicant Address | 2724 SOUTH PECK RD. Monrovia CA 91016 United States | |||
| Applicant Contact Telephone | 651-467-3014 | |||
| Applicant Contact | Mr. Chandrapaul Parsram | |||
| Applicant Contact Email | cparsram@mmm.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | 3M™ Transbond™ Orthodontic Adhesive | |||
| Common Name | Bracket adhesive resin and tooth conditioner | |||
| Classification Name | Adhesive, Bracket And Tooth Conditioner, Resin | |||
| Regulation Number | 872.3750 | |||
| Product Code | DYH | |||
| Legally Marketed Predicate Devices | ||||
| 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K083051 | FlowTain | DYH | ||
| K073697 | Transbond Supreme LV | DYH | ||
| K221695 | 3M™ Filtek™ Supreme Flowable Restorative | EBF | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| 3M Transbond Orthodontic Adhesive is a thixotropic, visible-light activated, radiopaque orthodontic adhesive. The product is stored in a | ||||
| multi-use syringe which is used with single-use dispensing tips. |
3M Transbond Orthodontic Adhesive contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium
trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20 nm silica | | | | |
| filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, and a surface modified aggregated zirconia/silica cluster
filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns.
The inorganic filler loading is approximately 65% by weight (46% by volume). | | | | |
| Intended Use/Indications for Use | | | | 21 CFR 807.92(a)(5) |
| 3M Transbond Orthodontic Adhesive is indicated for the following uses:
• Creating attachments for orthodontic tray aligners.
• Bonding orthodontic brackets to teeth. | | | | |
Indications for Use Comparison
21 CFR 807.92(a)(5)
4
The intended use of the proposed device and the predicate device, FlowTain (K083051), is the same.
The indications of use of the proposed device is substantially equivalent to the predicate device. Both products are indicated for use in for creating attachments for orthodontic tray aligners as well as bonding orthodontic brackets to the teeth.
21 CFR 807.92(a)(6)
Technological Comparison
The proposed device and the predicate device, FlowTain (K083051), have similar but not identical technological characteristics. Both devices are non-sterile, light-cured, single-paste resin adhesive packaged in a multi-use syringe with single-use needlepoint tips for dispensing.
Characteristics that are not identical between the proposed and predicate include curing conditions, nanomaterials, and materials used in the formulation.
Transbond Supreme LV (K073697) and 3M Filtek Supreme Flowable Restorative (K221695) are used as reference devices to demonstrate that the differences in technological characteristics between the proposed and predicate devices do not raise significant concern about safety or effectiveness. Transbond Supreme LV (K073697) and 3M Filtek Supreme Flowable Restorative (K221695) have similar curing conditions and are formulated with similar materials as the proposed device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following performance parameters were tested to demonstrate that the subject device performs as intended when used for creating attachments for orthodontic tray aligners or bonding brackets to teeth: Shear Bond Strength (adhesion), Depth of Cure (ISO 4049), Three-Body Wear Resistance, and Rheology.
FlowTain (predicate device) and/or 3M Transbond Supreme LV (reference device) were used as controls in these studies.
Not Applicable.
The performance bench studies and biocompatibility assesment show that the subject device is as safe, as effective, and performs as well as or better than the predicate and/or reference device.