# K110759: Tempocem

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Jun 10, 2011 after 84 days
- Product code: EMB (Zinc Oxide Eugenol)
- Device class: 1
- 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 K982590 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970775: Tempo Cem (Multiple), Foremost Dental Mfg., Inc. (1997) Summary page 1.
- K091735: DC Provi Cem Esthetic, Esthetic Multi F, Implant, S & C Polymer GmbH (2009) Summary page 1.

## Most influential descendants
- K142446: Fixtemp Cement (2015), 0 descendants of its own

## Indications for use
TempoCem is a dental luting agent indicated for * temporary cementation of provisional crowns and bridges * cementing of semi-permanent implants

Source page: https://510kreport.com/device/K110759
Methodology: https://510kreport.com/methodology