# K142446: Fixtemp Cement

- Pathway: 510(k) (Traditional)
- Applicant: Exacta Dental Direct, Inc.
- Decided: Jun 4, 2015 after 275 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: 3 generations back to K982590 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110759: Tempocem, Dmg USA, Inc. (2011) Summary page 4.

## Indications for use
FixTemp ™ Cement 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/K142446
Methodology: https://510kreport.com/methodology