# K970775: Tempo Cem (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Foremost Dental Mfg., Inc.
- Decided: Jun 3, 1997 after 91 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110759: Tempocem (2011), 1 descendant of its own
- K142446: Fixtemp Cement (2015), 0 descendants of its own

## Indications for use
TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges. Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device.

Source page: https://510kreport.com/device/K970775
Methodology: https://510kreport.com/methodology