# K031212: Temporary Resin Cement

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Jul 11, 2003 after 85 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TempBond Clear: named in the summary without a submission number
- (no number) Sensitemp: named in the summary without a submission number
- (no number) GC Temporary Cement: named in the summary without a submission number

## Most influential descendants
- K101044: Retrieve Implant Cement (2010), 0 descendants of its own

## Indications for use
A resin-based cement designed for use with provisional restorations such as crowns, inlays, onlays, fixed bridges, etc. or for temporary cementation of permanent restorations.

Source page: https://510kreport.com/device/K031212
Methodology: https://510kreport.com/methodology