# K994261: Ultratemp Temporary Polycarboxylate Cement

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Feb 2, 2000 after 47 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.
3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080768: Ultratemp Firm, Fast and Regular Set (2008), 2 descendants of its own
- K211237: UltraTemp Rez II (2021), 1 descendant of its own
- K261937: PacTemp Automix NE (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K994261
Methodology: https://510kreport.com/methodology