# K960954: Ketac-Molar Aplicap

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: May 16, 1996 after 66 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: 1 generation back to K843566 (1984). 2 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874788: Ketac-Bond Aplicap, Espe GmbH (Us) (1988) Summary page 1.
- K843566: Ketac-Silver, Espe GmbH (Us) (1984) Summary page 1.

## Most influential descendants
- K994251: Ketac-Molar Quick (2000), 1 descendant of its own
- K992966: Reference (1999), 1 descendant of its own
- K123826: Vitro Molar (2013), 0 descendants of its own
- K101493: Advanced Glass Ionomer (K-130) Restorative (2010), 0 descendants of its own
- K091826: Elegant (2009), 0 descendants of its own

## Indications for use
Ketac-Molar® Aplicap® is a glass ionomer cement material indicated for the following uses: (1) linings for Class I and II cavities filled with composite; (2) core build-ups; (3) fillings in deciduous teeth; (4) fillings in Class I cavities located in non-occlusal load bearing areas; (5) fillings in Class V cavities if the aesthetics are not of primary importance; and (6) temporary fillings in Class I and II cavities.

Source page: https://510kreport.com/device/K960954
Methodology: https://510kreport.com/methodology