# K071131: UNO

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Jul 25, 2007 after 93 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900510 (1990). 33 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060684: Adper Prompt, Adper Prompt L-Pop, 3M Espe AG Dental Products (2006) Summary page 1.
- K001494: Modification to Prompt L-Pop, Espe Dental AG (2000) Summary page 1.
- K043043: Hermes Bond 2, 3M Espe AG Dental Products (2005) Summary page 1.
- K020256: Unicem, 3M Espe AG Dental Products (2002) Summary page 1.
- K913965: Espe (R) -Sil, Espe GmbH (Us) (1991) Summary page 1.
- K992645: Sinfony, Espe Dental AG (1999) Summary page 1.

## Most influential descendants
- K110302: Adhesive Exl-759 (2011), 34 descendants of its own
- K112118: Dreambond (2011), 8 descendants of its own
- K161051: All-Bond Universal w/BAC (not finalized) (2016), 6 descendants of its own
- K153231: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer (2016), 5 descendants of its own
- K200798: G-Cem One (2020), 3 descendants of its own

## Indications for use
- All classes of fillings (according to Black) with light-curing composite or compomer - Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX T ARC, manufactured by 3M ESPE - Core build-ups made of light-curing composite - Root surface desensitization - Repair of composite or compomer fillings - Repair of restorations veneered with composite or ceramic - Bonding orthodontic appliances to teeth for orthodontic treatment

Source page: https://510kreport.com/device/K071131
Methodology: https://510kreport.com/methodology