# K984246: Prompt L-Pop

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental AG
- Decided: Jan 8, 1999 after 42 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: 3 generations back to K900510 (1990). 8 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962442: Hytac Aplitip/Hytac Osb, Espe GmbH & Co. Kg. (1996) Summary page 1.
- K935898: Hydrogum, Zhermack Dental Production (1995) Summary page 1.
- K974458: Compolute Aplicap, Espe Dental-Medizin GmbH & Co.Kg. (1998) Summary page 1.

## Most influential descendants
- K992966: Reference (1999), 1 descendant of its own
- K210945: Ultra SEP (2021), 0 descendants of its own
- K071688: Reliance S.E.P. (2007), 0 descendants of its own
- K993566: Promptflow (1999), 0 descendants of its own
- K992048: Modification of Prompt L-Pop (1999), 0 descendants of its own

## Indications for use
Bonding of Enamel/Dentin and Compomer Restorative Materials

Source page: https://510kreport.com/device/K984246
Methodology: https://510kreport.com/methodology