Company ยท US
3M Unitek
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2017. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 2017 | K163689 | 3M Clear Tray Aligner 3M Unitek Corporation | NXC |
| Feb 2, 2012 | K113197 | APC FLASH-FREE ADHESIVE 3M Unitek Corporation | DYH |
| Feb 17, 2011 | K102803 | CLARITY ADVANCED CERAMIC BRACKETS 3M Unitek Corporation | NJM |
| Jul 27, 2010 | K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE 3M Unitek | DYH |
| Feb 15, 2008 | K073697 | TRANSBOND SUPREME ADHESIVE 3M Unitek | DYH |
| Oct 18, 2006 | K062305 | CLARITY MODIFIED CERAMIC BRACKETS 3M Unitek | NJM |
| Apr 12, 2002 | K020394 | APC PLUS ADHESIVE 3M Unitek | DYH |
| Feb 28, 2002 | K014142 | UNITE BONDING ADHESIVE 3M Unitek | DYH |
| Mar 7, 1995 | K950514 | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT 3M Unitek | DYH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2025 | 3M Unitek Corporation 3M Unitek Transbond Plus Self-Etching Primer REF
712-090 (100 unit box)
712-091 (20 unit box)
Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bo Open, Classified |
KLE | K992048 |