3M Unitek
Medical device manufacturer in Monrovia, CA.
9510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 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 |
| K100536 | Transbond Idb Pre-Mix Chemical Care AdhesiveDYH · Traditional | 07/27/2010SE |
| 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 |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0797-2025 Class II | 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit…Due to an increase of complaints for bracket bond failures and skin irritation or blistering. | 11/26/2024Open, Classified |