# K040895: Integrity Temporary Cement

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: May 21, 2004 after 45 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 K853431 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853431: Dental Cement, Dentsply Intl. (1985) Summary page 1.
- K854253: Root Canal Filling Resin, Dentsply Intl. (1985) Summary page 1.

## Indications for use
INTEGRITY TM TEMPORARY CEMENT is indicated for: I. Temporary cementation of provisional acrylic and composite indirect restorations to prepared teeth or implant abutments. 2. Provisional or trial cementation of ceramic, porcelain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to prepared teeth or implant abutments. 3. Cementation of ceramic, porcelain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to implant abutments and telescopic fixed restorations which require periodic removal for maintenance., etc.

Source page: https://510kreport.com/device/K040895
Methodology: https://510kreport.com/methodology