# K080768: Ultratemp Firm, Fast and Regular Set

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Apr 11, 2008 after 24 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 K994261 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994261: Ultratemp Temporary Polycarboxylate Cement, Ultradent Products, Inc. (2000) Summary page 1.

## Most influential descendants
- K211237: UltraTemp Rez II (2021), 1 descendant of its own
- K261937: PacTemp Automix NE (2026), 0 descendants of its own

## Indications for use
UltraTemp Firm, Fast and Regular is a non-eugenol temporary cement indicated for interim cementation of inlays, onlays, crowns and bridges. It is methacrylate based and does not negatively affect resin bonding. Being water soluble until set, it cleans up easily.

Source page: https://510kreport.com/device/K080768
Methodology: https://510kreport.com/methodology