# K962785: 3M Dent System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Aug 12, 1996 after 26 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: 1 generation back to K942493 (1994). 2 ancestors in all.
45 later devices descend from it; 8 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942493: Scotchbond Multi-Purpose Plus Dental Adhesive System, 3M Company (1994) Summary page 1.
- K951864: Prime & Bond Direct Composite Bonding Agent, Dentsply Intl. (1995) Summary page 1.
- (no number) One Step™ Universal Dental Adhesive System: named in the summary without a submission number

## 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

Source page: https://510kreport.com/device/K962785
Methodology: https://510kreport.com/methodology