# K162960: TotalC-Ram

- Pathway: 510(k) (Abbreviated)
- Applicant: Itena Clinical
- Decided: Mar 14, 2017 after 141 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: 3 generations back to K924151 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121804: Provitemp, Dentotemp, Totalcem, Dentocem, Itena Clinical (2013) Summary page 4.

## Indications for use
It is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays.

Source page: https://510kreport.com/device/K162960
Methodology: https://510kreport.com/methodology