# K111685: IP Temp Cement

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Sep 2, 2011 after 78 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
IP Temp Cement, is temporary luting cement intended for temporary cementation of permanent restorations including crowns and bridges etc. or provisional restorations to natural teeth (intraoral hard tissue) or other materials (implant abutment etc.).

Source page: https://510kreport.com/device/K111685
Methodology: https://510kreport.com/methodology