# K153174: Ketac Universal Aplicap

- Pathway: 510(k) (Traditional)
- Applicant: 3M Deutschland GmbH
- Decided: Apr 13, 2016 after 162 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 K091106 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091106: EQUIA, GC America, Inc. (2009) Summary page 6.

## Indications for use
Linings for single-surface and multiple-surface composite fillings Core build-up prior to crown placement Primary tooth fillings Stress bearing Class 1 restorations with at least one additional support outside of the filling area Stress bearing Class Il restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area Cervical fillings, if aesthetics is not the prime consideration Single-surface and multiple-surface temporary fillings Fissure sealing

Source page: https://510kreport.com/device/K153174
Methodology: https://510kreport.com/methodology