Transbond Idb Pre-Mix Chemical Care Adhesive
FDA 510(k) K100536 · 3M Unitek
510(k) numberK100536
Submission
- Device name
- Transbond Idb Pre-Mix Chemical Care Adhesive
- Applicant
- 3M Unitek
Monrovia, CA, US - Received
- February 25, 2010
- Decision date
- July 27, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K234043 | 3M Transbond Orthodontic AdhesiveDYH · Traditional | 3M Unitek Orthodontic Products | 12/22/2023SE |
| 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 |
More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K163689 | 3M Clear Tray AlignerNXC · Traditional | 01/27/2017SE |
| K113197 | Apc Flash-Free AdhesiveDYH · Traditional | 02/02/2012SE |
| K102803 | Clarity Advanced Ceramic BracketsNJM · Traditional | 02/17/2011SE |
| K073697 | Transbond Supreme AdhesiveDYH · Traditional | 02/15/2008SE |
| K062305 | Clarity Modified Ceramic BracketsNJM · Traditional | 10/18/2006SE |
| K020394 | Apc Plus AdhesiveDYH · Traditional | 04/12/2002SE |
| K014142 | Unite Bonding AdhesiveDYH · Traditional | 02/28/2002SE |
| K950514 | Tri-Cure Glass Ionomer Orthodontic Band CementDYH · Traditional | 03/07/1995SE |
Questions and answers
When was Transbond Idb Pre-Mix Chemical Care Adhesive cleared by the FDA?
Transbond Idb Pre-Mix Chemical Care Adhesive (K100536) received a 510(k) decision of Substantially Equivalent on July 27, 2010, 152 days after the submission was received.
What is the product code of K100536?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.