# K040857: Modification to Adper Prompt

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: May 10, 2004 after 38 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: 2 generations back to K001494 (2000). 3 ancestors in all.
39 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020946: Adper Prompt, 3M Espe AG Dental Products (2002) Summary page 1.
- K992292: Gluma Comfort Bond + Desensitizer, Heraeus Kulzer, Inc. (1999) Summary page 1.

## Most influential descendants
- K060684: Adper Prompt, Adper Prompt L-Pop (2006), 38 descendants of its own
- K071131: UNO (2007), 35 descendants of its own
- 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

## Indications for use
Bonding between dentin/enamel and composite filling materials Bonding between dentin/enamel and compomer filling materials Bonding mediator for fissure sealing Desensitization of hypersensitive areas of teeth

Source page: https://510kreport.com/device/K040857
Methodology: https://510kreport.com/methodology