3M Transbond Orthodontic Adhesive
FDA 510(k) K234043 · 3M Unitek Orthodontic Products
510(k) numberK234043
Submission
- Device name
- 3M Transbond Orthodontic Adhesive
- Applicant
- 3M Unitek Orthodontic Products
Monrovia, CA, US - Received
- December 21, 2023
- Decision date
- December 22, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code DYH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261129 | OrthoFitDYH · Traditional | Spident Co., Ltd. | 07/02/2026SE |
| K261840 | BracePaste Prime PlusDYH · Traditional | American Orthodontics | 06/03/2026SE |
| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree AdhesiveDYH · Traditional | Ormco Corporation | 01/03/2025SE |
| K242537 | BracePaste Fluoride SealantDYH · Traditional | American Orthodontics Corp. | 08/27/2024SE |
| K231817 | AlignerFlow LCDYH · Traditional | Voco GmbH | 12/01/2023SE |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…DYH · Traditional | Tp Orthodontics, Inc. | 10/14/2022SE |
| K210115 | FiteBac CC OrthoSealDYH · Traditional | Largent Health, LLC | 07/29/2021SE |
| K202276 | BracePaste Band and Build LCDYH · Traditional | American Orthodontics | 08/14/2020SE |
| K192682 | Orthocem, Ortho BiteDYH · Traditional | Dentscare Ltda | 08/14/2020SE |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok LiquidDYH · Traditional | Reliance Orthodontic Products, Inc. | 04/27/2020SE |
Questions and answers
When was 3M Transbond Orthodontic Adhesive cleared by the FDA?
3M Transbond Orthodontic Adhesive (K234043) received a 510(k) decision of Substantially Equivalent on December 22, 2023, 1 days after the submission was received.
What is the product code of K234043?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.