# K992048: Modification of Prompt L-Pop

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Aug 16, 1999 after 60 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K900510 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984246: Prompt L-Pop, Espe Dental AG (1999) Summary page 1.

## Recalls of this device
- Nov 26, 2024 · Class II · Z-0797-2025: Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

## Indications for use
Bonding between dentin/enamel and composite filling materials. Bonding between dentin/enamel and compomer filling materials. Bonding mediator for fissure sealing Bonding mediator for bracket attachment

Source page: https://510kreport.com/device/K992048
Methodology: https://510kreport.com/methodology