# K973262: Ketac-Fil Aplicap Plus

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: Nov 17, 1997 after 80 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K843566 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925027: Photac-Fil Aplicap, Espe GmbH (Us) (1993) Summary page 1.
- K960954: Ketac-Molar Aplicap, Espe GmbH & Co. Kg. (1996) Summary page 1.

## Indications for use
Fillings of Black Classes III and V cavities Wedge-shaped defects Fissure sealing Small Black Class I cavities Deciduous teeth Core build-ups

Source page: https://510kreport.com/device/K973262
Methodology: https://510kreport.com/methodology