# K160443: TempoCem Clear

- Pathway: 510(k) (Traditional)
- Applicant: Dmg USA, Inc.
- Decided: Sep 30, 2016 after 226 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 K042846 (2004). 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)
- K042846: Systemp.Link, Ivoclar Vivadent, Inc. (2004) Summary page 4.

## Indications for use
TempoCem Clear is indicated for: » Temporary or semipermanent luting of temporary and permanent crowns, bridges, inlays and onlays. * Temporary luting of temporary veneers * Temporary or semipermanent luting of implant-borne dental prosthesis.

Source page: https://510kreport.com/device/K160443
Methodology: https://510kreport.com/methodology