# K121804: Provitemp, Dentotemp, Totalcem, Dentocem

- Pathway: 510(k) (Abbreviated)
- Applicant: Itena Clinical
- Decided: Apr 19, 2013 after 304 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: 2 generations back to K924151 (1992). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032470: Multilink, Ivoclar Vivadent, Inc. (2003) Summary page 1.
- K022476: Relyx Rmgip, 3M Company (2002)
- K012316: Permacem / Permacem Dual, Dmg USA, Inc. (2001) Summary page 1.

## Most influential descendants
- K162960: TotalC-Ram (2017), 0 descendants of its own

## Indications for use
It is intended for the cementation of posts, crowns, bridges, inlays and onlays. It is intended for permanent cementation of: * crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, Maryland bridges and veneers; * implant prosthesis; * orthodontic attachments; * amalgam restorations; * veneering of alloys; and * composite restorations.

Source page: https://510kreport.com/device/K121804
Methodology: https://510kreport.com/methodology